Do you have a BS degree in Microbiology or Biology and some experience in a QC environment, or looking to use your degree and step into one? If you're looking for a great company focused on Animal Health and Enzymes, tremendous opportunity to grow in skills and roles, as well as a fun and close-knit team, this could be the QC Lab Tech opportunity for you!
This role is located onsite at the New Berlin facility and is 7am-3pm M-F; as well as a few hours every 4th Saturday.

What You'll Do:

This position works under general supervision and is primarily responsible for using laboratory equipment and standardized procedures to test and evaluate the company’s products with regard to quality standards. Responsibilities include:

Knowledge, Skills & Abilities:

Candidates should have a BS Degree in Microbiology or Biology and preferably 1-3 years experience in a similar QC Lab Tech position; candidates without these degrees or experience will be considered. Individuals within this role will need:
:

Take the next big step in your career and Apply Now!
Questions? Contact Andie Veach directly at Andie@CarexScientific.com

 

Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.

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Are you a Molecular, Cell or Protein Scientist with a PhD and lab experience? Are you looking to either move your sales career forward, or make the step from the lab into sales? This is the role for you!

Our biotech partner is seeking a Scientific Client Representative for a Home-Based scientist in the San Francisco area that will develop strong relationships with clients there. It's critical that you have at least a Bachelor's degree in a science field and have solid lab experience (while earning your degree or after) . *This role will be remote/home-based and will require the individual live in the San Francisco area in order to regularly meet with clients at their site.

A little about the team: 

We are a close knit team focused on our clients and supporting one another. Honesty, integrity, mutual respect, open communication, and advocacy are woven into our team values. Our approach is science led, to make sure we are aligning our efforts to best support our clients’ research focus, and develop long-term, consultative relationships. Our team partners closely with nearly every other area of the company, providing a new challenge and learning opportunity every day.

 

YOUR ROLE: As a Scientific Client Representative, you’ll support and engage with local researchers at institutes in the San Francisco area to align solutions of value to their scientific efforts. You’ll interact with the fascinating folks who utilize our products and you’ll have an ability to help both our team and company learn more about them and their science, building bridges between HQ & researchers. Although you’re a solo act, you’ll never be alone as we have a deep network of overlay teams ready to collaborate with and assist you.

CORE DUTIES:

1. Sales Behaviors:

2. Sales Tools (Outlook/CRM/PowerBI/LinkedIn/Showpad):

3. Branch Initiatives:

4. Continuous Improvement

5. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.

6. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

 

KEY QUALIFICATIONS:

 

1. Minimum BS or BA (M.S./Ph.D. preferred) in Life Sciences with a focus on hands-on laboratory experience in Molecular Biology, Cell Biology and/or Protein Biochemistry.

2. Strives to incorporate the Core Emotional Social Intelligence (ESI) Principles in their position (Check in with yourself, Listen with empathy, Enhance self-esteem, Look for the good, with discernment, encourage diverse perspectives and Use courage and compassion to say what needs to be said).

3. Flexible in handling change, meeting a standard of excellence, persistent in pursuing goals despite obstacles and setbacks. Self-awareness of how behaviors can affect our colleagues. Keeping disruptive emotions and impulses in check, sensing other’s feelings and perspectives to advocate and voice opinions and viewpoints appropriately within and outside our company.

4. Independently motivated and works well with others.

5. Excellent communication skills (oral/written).

6. Excellent organizational skills.

7. Strong commitment to customer service. Excellent communication, strong analytical and conflict resolution ability.

8. Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook), e-mail and the use of the Internet.

If you're looking for a great opportunity apply now!

Questions? Contact Andie Veach at andie@carexscientific.com

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Senior Lab Automation Engineer with Scheduling Software Experience (GreenButtonGo, Momentum, etc.) – $20,000 Sign-On Bonus and do meaningful work in the Cancer field!
 

This is an excellent opportunity for an expert in lab automation and scheduling software to step into a key role with an industry leader! The position will be onsite initially with the Oncology Business Unit in Redwood City, CA, and have significant hybrid flexibility!
 

What We Do:
The Mission of the Precision Oncology Business Unit is to transform treatment decisions and outcomes in cancer by delivering clinically actionable diagnostics, both as in-vitro diagnostic (IVD) devices and as Laboratory Developed Tests (LDTs) conducted in the Redwood City Clinical Laboratory. The Senior Laboratory Automation Engineer will provide technical expertise to drive continuous improvement of state-of-the-art diagnostic tests for cancer patients.

What You'll Do:
The Process Engineering team is a multidisciplinary group of engineers with backgrounds in mechanical, electrical, software, and process engineering.  The Senior Laboratory Automation Engineer work will focus on designing, building, and optimizing integrated laboratory automation systems. The process engineering team has direct involvement throughout the lifecycle of automation development; including design, build, test, launch, and continuous improvement.

The successful candidate will be a key member on project teams developing integrated systems laboratory automation, ensuring their efficient and effective transfer into production, and will also contribute to ongoing improvements of existing commercialized processes and products.

Essential Responsibilities:

 

What You'll Bring:

Preferred Additional Qualifications:

Apply Now and start the next step of your career!
Questions? Feel free to contact Ginger Auchter directly at Ginger@carexscientific.com

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If you're a Regulatory Affairs Engineer with several years of experience in Medical Device and Instrumentation, we have an amazing role for you!

What You'll Do:

We are a small team of very motivated and energetic individuals. We are always seeking to drive speed to market by the least burdensome, but compliant path.  We work very closely together on new product development and realization projects and ensure that we support each other in our day-to-day roles and in our department.

As part of our Regulatory Affairs team, you will be an important part of our new laboratory instrumentation product development and realization teams from start to finish making sure all regulatory compliance is met. You will work with cross-functional teams and external testing vendors to ensure that our electronic and electrical equipment complies with international standards and regulations. 

 

In this role you'll be able to work closely with Engineering, Quality Assurance, Regulatory Affairs, and Operations to provide technical interpretation of regulatory and reliability requirements for new instrumentation product launches and changes throughout the product lifecycle. Key responsibilities include:

1. Identify applicable regulatory requirements during product development and support compliance activities related to the company's analytical instruments and systems.
2. Understand new and changing regulations for electrical and electronic equipment and in vitro diagnostic medical devices to determine impact on new and existing products.
3. Plan and lead Safety, Laser and EMC/EMI testing, including collaboration with external test labs.
4. Serve as a key member of cross-functional engineering teams (internal and external) consisting of optical, electrical, software, mechanical, manufacturing, and quality engineers to develop high-performance analytical instruments.
5. Evaluate product design changes for impact on compliance to applicable regulations and standards.
6. Lead cross-functional initiatives to maintain product licenses and registrations.
7. Support company registrations and medical device listings in the US, Canada, EU, UK, China, and others as needed.
8. Consider all aspects of system reliability including mechanical and electronic failures and user error.
9. Author content and seek input from others on the creation and maintenance of technical files in support of Declarations of Conformity.
10. Support internal and external audits and regulatory inspections.
11. Support products post-launch by evaluating field failures and recommending specific design improvements.
12. Support preparation of proposals, project plans, and cost estimates.
13. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity, and respect for others.
14. Embracing and being open to incorporating the company's Emotional & Social Intelligence (ESI) core principles in daily work.
15. Understands and complies with ethical, legal, and regulatory requirements applicable to our business.

What You'll Bring:

1. Bachelor’s Degree (BS) or equivalent in engineering, technical and/or scientific discipline.
2. Minimum 4 years of Regulatory Engineering experience in instrumentation, electrical equipment or safety engineering.
3. Extensive knowledge of key electrical equipment standards for EMC, including EN 61326-1, and safety, including CAN/CSA C22.2 No. 61010-1-12, IEC 61010-1, EN 60825, and UL 61010-1.
4. Extensive knowledge of international regulatory requirements, including FDA, Conflict Minerals, Canada, EU (including RoHS).
5. Proficient in software tools for structured reliability modeling and statistical analysis.
6. Demonstrated ability to perform and/or direct testing, including performance, life, and EMC/EMI.
7. Excellent conceptual, analytical, and problem-solving abilities.
8. Working knowledge of FDA Quality System Regulations, ISO 13485, and ISO 9001.
9. Must be able to manage various activities and priorities with minimal direction. Strong attention to detail and sound ability to interpret, translate and address regulatory needs.
10. Excellent written and oral communication skills. Demonstrated ability to comply with regulations while meeting business needs. Able to present information within teams and groups.
11. Strong interpersonal skills and ability to work independently and cooperatively in teams, including as a project manager.

 

Ideal Experience:
1. 4 – 6 years of combined Regulatory and Quality experience.
2. 10 years industry experience, with a minimum of 4 years as a regulatory engineer or equivalent.
3. Knowledge and experience with medical device standards, including IEC 60601-1.
4. Working knowledge of electronics, enough to understand and assess electronic circuits and hardware designs.
5. Knowledge and experience with test results being used in successful FDA and rest of world submissions.

 

Apply Now and move your career forward with an exciting and highly respected biotech leader!
Questions? Contact Ginger Auchter directly at Ginger@CarexScientific.com

Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.

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Are you looking to use your Regulatory / QA experience with invitro diagnostics or medical devices at a company you can grow and be valued in? This could be the perfect role for you!

What You'll Do:

The Regulatory Scientist will provide regulatory support to different areas of the company to ensure that products comply with relevant domestic and international invitro diagnostic medical device and electrical equipment regulations. You will also be able to assist in the development and maintenance of required documentation to support regulated products, as well as support the preparation activities for submissions to regulatory authorities.

Key Responsibilities Include:
1. In collaboration with RA leadership and subject matter experts, evaluate regulatory impact of proposed products.
2. Research and evaluate regulatory requirements.
3. Provide regulatory guidance and assess regulatory implications for products throughout the product lifecycle.
4. Work with cross-functional teams to prepare regulatory applications, registrations, and submissions to regulatory authorities.
5. Maintain documentation needed to support regulated product throughout the product’s lifecycle.
6. Review and approve product labels (label disclaimers).
7. Review and approve product literature for compliance to applicable regulations.
8. Facilitate risk assessments for regulated products.
9. Evaluate risks based on regulatory factors, provide options and recommendations to mitigate risk.
10. Organize, facilitate, or lead meetings to discuss review findings and planning issues.
11. Provide regulatory support for other branches as needed.
12. Develop and conduct regulatory training, as needed.
13. Assist with writing SOPs as needed.
14. Provide regulatory input for complaint investigations and product recalls.
15. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
16. Embracing and being open to incorporating the company's Emotional & Social Intelligence (ESI) core principles in daily work.
17. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

What You'll Bring:

1. Bachelor’s degree in life science, chemistry, or other relevant field.
2. Minimum of 3 years quality assurance or regulatory experience with a graduate degree or 10 years’ quality assurance or regulatory work experience with a bachelor’s degree.
3. Good understanding of applicable FDA regulations and EU Directives.
4. Experience in writing and reviewing documents required to support regulated products.
5. Proficiency with basic word processing and spreadsheet software programs.
6. Ability to develop concise, clear communication and presentations that contain both analysis and possible solutions.
7. Proven ability to work effectively with a broad range of people, both internally and externally, to achieve results.
8. Effective communication skills.

Ideal (but not required) Qualifications:
1. Regulatory Affairs Certification (RAC).
2. Experience in developing EU Technical Files to support regulated product.
3. Experience in developing compliance files or submissions to support regulated product in other markets.

 

Apply Now and move your career forward with an exciting and highly respected biotech leader!
Questions? Contact Andie Veach directly at Andie@CarexScientific.com

Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.

#LI-GA1

Do you have Quality System experience in API drug development and a passion for mental health treatment? This could be the perfect leadership role for you!

What You'll Do:

The Director, Quality Assurance is responsible for the strategic development and execution of the quality assurance program including all quality-related decisions. This position reports to the Founder and Executive Director for the execution and administration of all GXP Quality Systems and is directly accountable for cGMP, GLP, GCP and GVP compliance in accordance with ICH, US, EU, and other relevant regulations.
This role is expected to lead a team and collaborate across the organization on all quality matters and develop strong relationships with external consultants and contractors as necessary to support QA activities and responsibilities. The opportunity requires expertise in current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP) and relevant regulations across multiple jurisdictions. The successful candidate will drive, promote, and embed a culture of ethics, integrity, and continuous improvement focused on delivering efficiencies and maximizing the company's impact within its field of research.

Key Responsibilities:
  Ensures that the Quality Management System meets standards expected by US and global regulatory authorities for research, development, and ultimately commercial activities.
  Ensures quality metrics comply with best industry standards and practices.
 Maintains effective quality governance and continually improves governance to meet organizational and compliance needs.
  Accountable for overall quality and compliance oversight to include manufacturing, supply chain, nonclinical, and clinical functions.
  Establishes strong working relationships with external product manufacturers and assures alignment of Quality Management Systems and requirements with these CMOs. Ensures that products manufactured at CMOs meet organizational quality standards and government regulations.
  In collaboration with Clinical team, provides appropriate quality oversight of CROs.
  Establishes, maintains, and leads oversight of internal Quality Management Systems. Continually evaluates and improves quality-related initiatives, priorities, and timelines.
  Ensures that appropriate quality criteria are built into the selection/implementation of, and upgrades to, electronic systems used to support any GXP related activities.
  Provides leadership and mentorship to the Quality team. Plans and oversees day-to-day activities of the Quality function including management of consultants/auditors as needed to ensure project and business needs are met.
  Keeps abreast of industry developments, forthcoming regulations, guidance, best practices, etc.
  Interprets and applies quality requirements and provides guidance and training to ensure that the company and its GxP vendors maintain an ongoing state of compliance.
  Communicates significant quality risks that may impact product suitability or regulatory compliance in a timely manner to the Leadership Team.
  Serves as an escalation point for organizational compliance and quality issues.
  Serves as a primary contact in any audit by a regulatory authority and leads all audit communications with audit personnel from a regulatory agency. Responsible for supplier/vendor qualification audit and inspection management.
  Conducts all duties in compliance with country-specific regulations, applicable SOPs, and other applicable guidelines.
  Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
  Embraces and is open to incorporating the Emotional & Social Intelligence (ESI) core principles in daily work.
  Understands and complies with ethical, legal and regulatory requirements applicable to our business.

What You'll Bring:

  Bachelor’s degree, preferably in the life sciences.
  15+ years of relevant experience in GXP, QA leadership positions in a Biotech and/or Pharmaceutical industry.
  Extensive knowledge and in-depth experience of implementation of Quality regulations in clinical, laboratory and pharmaceutical manufacturing environments for USA, EU and other global Health authorities.
  Familiar with ICH Quality Guidelines and a demonstrated ability to utilize ICH Q9 / Quality Risk Management principles in everyday practice.
  A hands-on leader with previous managerial experience who leads by example, inspires, and empowers team members.
  Proactive in identifying opportunities with a strong solution-minded approach and flexibility to emerging challenges based on the scope and growth of the organization.
  Strong collaborative, influencing, and interpersonal skills
  Excellent verbal, written, and presentation skills with the ability to deal effectively across all levels of management.
  Ability to prioritize competing activities, manage resources, and budget accordingly.

Ideal Qualifications (Not required)
  Master’s Degree
  Experience/familiarity with regulations related to controlled substances
  Proficiency with Microsoft Word, Excel, and Outlook.
 

Apply Now and move your career forward with a great team and non-profit leader in mental health!
Questions? Contact Andie Veach directly at Andie@CarexScientific.com
 

Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.

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If you're well-versed in Digital Building Automation Control Systems and BAS programming, and have great project management skills, we have an exciting opportunity for you! Come join a thriving Biotech leader as a Building Automation Engineer and grow into the SME across the organization when it comes to Building Automation needs!
Note this role is based out of Madison, WI; full relocation is available.

 

What You'll Do:

As part of the facilities team, you will love working with different groups of individuals ranging from outside vendors to internal customers. With the growing number of buildings on campus, you will collaborate with resources to design, troubleshoot, or manage, facility-related building automation needs. This role will be integral in providing building automation and project management support for Facilities Services to meet organizational goals and objectives. Role responsibilities include:

OCCASIONAL DUTIES:

What You'll Bring:

Preferred Qualifications

 

Take the next big step in your career and Apply Now!
Questions? Contact Ginger Auchter directly at Ginger@CarexScientific.com
 

Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.

 

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Are you a Process Validation Engineer with Process Validation Development and Execution experience within a Biotech, Pharma or similar manufacturing environment? If you're looking to join a leading Biotech company in the Madison area with a great team and lots of room for growth, this opportunity is for you!

What You'll Do:
This role is a key part of the Operations Validation Team. The team is made up of different specialists who play multiple roles including statistical data scientists, process validation engineers, and analytical method validation engineers that provide their expertise in all things Validation. This includes validating products, processes, analytical methods, and qualifying equipment that supports the Class 1 Medical Devices. The diverse internal clientele includes all areas of the company's Bulk Manufacturing, Customs Manufacturing and R&D business units.

In this role you'll have an opportunity to lead and execute validation and qualification activities of equipment and processes while working in a team environment. Independently draft, review, execute validation and qualification protocols per industry practices and internal guidelines. The position requires working knowledge and experience in the qualification of bulk manufacturing process equipment and facilities utilities. Experience with equipment and process validation is highly desirable. Additional key responsibilities include:

What You'll Bring:

PREFERRED QUALIFICATIONS (We encourage you to apply even if you do not have the following):

ADDITIONAL NEEDS OF ROLE:

 

Take the next big step in your career and Apply Now!
Questions? Contact Ginger Auchter directly at Ginger@CarexScientific.com
 

Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.

 

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Looking to further your QA career with a leader in Biotech? If you have a scientific background and significant experience in quality system operation processes, we have the perfect Supervisor, Quality Assurance role for you!

What You'll Do:
As part of the Product Quality Assurance team, you will lead a team of Quality Assurance Specialists and/or Scientists as well as apply your quality and scientific knowledge to provide product support as an individual contributor.

We are looking for someone with a scientific background and quality experience that includes working knowledge and direct application experience of the requirements of quality assurance systems in a manufacturing and/or product or process development environment. This role will include:
– Support QA Management in establishing direction and leadership for and participating in QA’s role in supporting the company's catalog and custom products. 
– Direct and oversee the involvement of QA Scientists and Specialist/Senior Specialist staff.
– Ensure that QA staff support business, regulatory, and quality system requirements.
– Provide direction to staff and resource allocation as needed.
– Ensure that QA fulfills its role in verifying product claims and supporting external customer needs.
– Utilize key performance indicators to identify areas for improvement and to justify departmental resources.
– Ensure that records are produced and maintained according to procedural requirements.
– Provide daily support for QA-owned processes, including but not limited to batch record review, deviations, investigations, quality holds, product stability program, New Product Realization, and review/approval of work instructions, labeling, and certificates of analysis.
– Recruit, manage and develop staff to meet departmental and business needs. Provide coaching, career development and performance expectations to staff in performance review process.
– Represent Quality Assurance on cross-functional teams and in interactions with other departments.
– Work with QA Director and QA Manager to develop departmental staffing, budget, training and capital expense plans annually or as necessary and required to meet departmental and business needs.
– Creation, review and approval of product batch records, work instructions, labels, and product literature, process changes, investigations, deviations, and corrective/preventive actions, as needed.
– Assure that new products meet their design requirements and performance requirements through participation in new product development teams.
– Make decisions regarding product quality and product release, including nonconforming product situation, quality hold, and general disposition planning.
– Establish and approve shelf-life assignments for catalog and custom products in cooperation with Manufacturing, Marketing and R&D staff. This includes approval of study design, data review, and Process Change approval.
– Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
– Understands and complies with ethical, legal and regulatory requirements applicable to our business.

OCCASIONAL DUTIES:
– 
Represents the company in discussions/interactions with external customers and suppliers.
– Present updates or training on projects/programs to leadership or company employees as required.
– Organize, facilitate, or lead cross departmental teams.
– Participate in training programs in areas of expertise and experience.

What You'll Bring:
– A B.S. or M.S. plus 8 years experience, or a Ph.D. plus 5 years experience in a scientific area such as molecular biology, cell biology, proteomics or chemistry, or Quality Assurance related field.
– Demonstrated experience and technical understanding of development, manufacturing and quality assurance processes for life science research products. Ability to troubleshoot, define problems and develop solutions, and bring improvements to bear in a technical setting.
– Demonstrated experience in achieving results in a cross functional environment.
– Advanced communication skills, both verbal and written.
– Independent self-starter with proven analysis planning, leadership, and project management skills.

PREFERRED QUALIFICATIONS (We encourage you to apply even if you don't meet those listed below):
– Demonstrated skills in the recruitment, coaching and development of staff to meet organizational needs.
– Experience in professional QA organization.
– Understanding of ISO13485 and QSR Quality System requirements.
– Demonstrated results and experience in an ISO, cGMP, or other regulated environment.

 

Apply Now and catapult your career forward!
Questions? Contact Ginger Auchter directly at Ginger@CarexScientific.com

Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.

 

#LI-GA1

 

 

Do you have significant QA experience in In Vitro Medical Devices and are looking for a leading biotech company you can continue growing your career in?
This high level QA Scientist role is made for you!

What You'll Do:
In this role you'll play a key role in assuring product quality and compliance to quality system requirements (QSR) pertaining to the manufacture of in vitro diagnostic medical devices.

Key Responsibilities:

  1. Work independently and with cross-functional teams to assure QSR compliance with applicable regulations (US FDA 21CFR820, Europe IVDR, Health Canada regulations, MDSAP requirements, ISO 13485, etc.).
  2. Review and assist in the development of reports, protocols, and SOPs for new and current products.
  3. Execute the following activities when appropriate:
    1. Review and approve batch records, stability data and validation results to ensure that products meet requirements.
    1. Review and approve technical literature content for accuracy and consistency.
    1. Assess the scope and inventory impact of nonconforming product situations; approve disposition plans of inventory product on hold and assist in the disposition planning for nonconforming product.
  4. Demonstrate leadership within the Product Quality Team.
  5. Act as QA lead on new product development cross-functional teams.
  6. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
  7. Embracing and be open to incorporating the company's 6 Emotional & Social Intelligence (ESI) core principles in daily work.
  8. Understand and comply with ethical, legal and regulatory requirements applicable to our business.

 What You'll Bring:

  1. Bachelor of Science degree in life science or chemistry.
  2. Minimum of 7 years’ experience that includes time spent working in Medical Device industry. Experience should be in manufacturing, process development, quality control or quality assurance.
  3. Five (5) years Working knowledge of ISO13485 requirements. Direct experience working in an FDA regulated system.
  4. Proven ability to work constructively with a broad range of people, backgrounds, and functions.
  5. Ability to apply effective critical thinking skills in complex problem solving and decision making to achieve positive results.
  6. Ability to develop concise, clear written communication and presentations that contain both analysis and possible solutions.
  7. Ability to effectively prioritize and manage workload in an environment with frequent interruptions and changing priorities and timelines.
  8. Experience leading department or corporate projects in a positive team environment.
  9. Proficiency with basic word processing and spreadsheet software.

Preferred (Not Required) Experience:

1.  Direct experience in quality field related to in vitro diagnostic medical devices.

Apply Now and move your career forward with an exciting and highly respected biotech leader!
Questions? Contact Andie Veach directly at Andie@CarexScientific.com

Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.

#LI-GA1

Are you highly skilled in Equipment Qualification, Method Validation, and overall QA Validation and looking to take your next big career step? We have a great team of Engineers and Scientists that are waiting to meet you!
 

What You'll Do:
You are our Quality go-to for equipment qualification of equipment used to manufacture medical devices. You have a passion and demonstrated experience establishing procedures for validating equipment and processes, evaluating risk and serve as our expert on all things validation related.

You have an extensive background in IVD/Medical device validation, including molecular method and process validation. Ideally your experience would include filling, packaging and other manufacturing equipment. You are a complex thinker and have the ability to communicate across all levels of the organization. Strong cross functional teamwork experience is desired.

Essential Duties:

This role will be responsible for managing and performing the Process Validation activities for all manufacturing equipment, manufacturing processes, and critical utilities. This includes:

– Work with the Manufacturing Support and Technology (MSAT) engineering and validation teams to produce resource estimates and schedules for the process validation tasks on new projects. Manage scheduled activities to ensure the successful completion of validation tasks.

– Review validation master plans for validation projects.

– Responsible for approval of process validation test procedures and acceptance criteria for process equipment and critical utilities validation protocols.

–  Assist validation lead in turnover of validated systems to process owners.

– Implement and coordinate validation activities in support of Quality Systems Regulation (QSR) compliant manufacturing.

– Establish procedures for validating equipment, processes, and Quality Control (QC) methods.

– Create process maps for manufacturing and QC processes; utilize maps for validation planning.

– Assist Project Managers in developing the validation needs within project plans and identifying the resources required for successful implementation of validations.

– Serve as process validation equipment qualification subject matter expert (SME) for the company in the IVD (21 CFR Part 820) regulated industry.

– Serve as technical resource for specification of equipment for automation projects.

– Proactively maintain a working knowledge of current industry trends and developments in the validation field including equipment facilities and utilities.

– Demonstrate inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.

– Embracing and being open to incorporating the company's core principles in daily work.

– Understand and comply with ethical, legal, and regulatory requirements applicable to the business.

OCCASIONAL DUTIES:

– Provide support to management for special projects or duties.

– Present updates and departmental information at various company meetings.

– Attend relevant validation meetings and technical seminars.

What You'll Bring:

– BS in engineering, chemistry, biochemistry, or related science field.

– 5 or more years of process validation development and execution experience in a manufacturing environment in a biotech, pharmaceutical, or IVD industry.

– Strong interpersonal and communication skills.

PREFERRED QUALIFICATIONS:

– Advanced degree in engineering related discipline.

– Validation Engineer certification.

– 3 or more years of process validation development and execution experience in a manufacturing environment in the medical device industry.

– Experience implementing automated packaging equipment projects.

PHYSICAL DEMANDS:

– Ability to observe and inspect equipment and operations for proper operation and compliance to safety and housekeeping standards.

– Ability to work in a production environment around automated equipment.

– Ability to work in an office environment utilizing a computer workstation.

– Ability to work in a lab environment with chemical, biological, and packaging materials.

– Ability to travel by car or airplane to suppliers, equipment vendors, trade shows, etc.

 

Apply Now and move your career forward with an exciting and highly respected biotech leader!
Questions? Contact Ginger Auchter directly at Ginger@CarexScientific.com

 

Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.

 

#LI-GA1

Do you have a strong background in API's and experience building out quality systems to support ongoing production? Want to work in a brand-new facility of a global Biotech leader with amazing Scientists and Engineers as colleagues? This could be the perfect role for you!

What You'll Do:

The Manager, Quality Assurance – API is responsible for providing the direction and leadership for quality assurance processes for product quality and GMP compliance of contract manufactured Active Pharmaceutical Ingredient (API) products. This will include:
– Manage QA staff involved in key processes such as CAPA, Nonconformances, Change Control, Audit, Training, and Document Control & and Records related to the manufacture of API products.
– Design, develop, and manage key quality system processes to ensure compliance with the requirements for API products.
– Work with QA leadership to improve quality system processes and overall quality and regulatory activities.
– Participate in both internal and external audits; play an active role in maintaining an inspection ready state.
– Represent the company in discussions/interactions with regulatory bodies, partners, vendors, or customers.
– Actively coach, mentor and develop team members and leaders within the department.
– Lead and support cross-departmental, corporate, and team projects and initiatives.
– Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Act with kindness, curiosity and respect for others. 
– Understand and comply with ethical, legal and regulatory requirements applicable to our business.

What You'll Bring:

– University degree (B.S. or M.S.) in a biological or chemical science or other relevant field.
– Minimum of 10 years related experience in quality control, quality assurance, product support, or manufacturing.
– Working knowledge of quality standards governing API products including 21 CFR 210 & 211 and ICH Q7.
– Ability to understand basic statistical concepts and analytical data.
– Ability to communicate (in written and oral forms) in a concise, clear, and accurate manner.
– Proven ability to work constructively with a broad range of people, backgrounds, and functions.
– Ability to perform analysis of complex problems or data requiring in-depth evaluation of various factors.
– Exercise judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
– Proficient with electronic tools including Microsoft Office applications and eQMS programs.

PREFERRED QUALIFICATIONS:
– Technical knowledge or experience in scientific areas specifically applicable to small molecule drug manufacturing.
– Previous experience managing FDA inspections.

 

Apply Now and move your career forward with an exciting and highly respected biotech leader!
Questions? Contact Andie Veach directly at Andie@CarexScientific.com

 

Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.

 

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Are you a Molecular, Cell or Protein Scientist with some lab experience and a passion for the client and sales side? This is the role for you!

Our biotech partner is seeking a Scientific Client Representative for a remote role based in San Diego, San Francisco, or the Pacific Northwest that will develop strong relationships with clients there.  It's critical that you have at least a Bachelor's degree in a science field and have some lab experience (while earning your degree or after) . 

A little about the team: 

We are a close knit team focused on our clients and supporting one another. Honesty, integrity, mutual respect, open communication, and advocacy are woven into our team values. Our approach is science led, to make sure we are aligning our efforts to best support our clients’ research focus, and develop long-term, consultative relationships. Our team partners closely with nearly every other area of the company, providing a new challenge and learning opportunity every day.

 

YOUR ROLE: As a Scientific Client Representative, you’ll support and engage with local researchers at institutes in your area to align solutions of value to their scientific efforts. You’ll interact with the fascinating folks who utilize our products and you’ll have an ability to help both our team and company learn more about them and their science, building bridges between HQ & researchers. Although you’re a solo act, you’ll never be alone as we have a deep network of overlay teams ready to collaborate with and assist you.

CORE DUTIES:

1. Sales Behaviors:

2. Sales Tools (Outlook/CRM/PowerBI/LinkedIn/Showpad):

3. Branch Initiatives:

4. Continuous Improvement

5. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.

6. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

 

KEY QUALIFICATIONS:

 

1. Minimum BS or BA (M.S./Ph.D. preferred) in Life Sciences with a focus on hands-on laboratory experience in Molecular Biology, Cell Biology and/or Protein Biochemistry.

2. Strives to incorporate the Core Emotional Social Intelligence (ESI) Principles in their position (Check in with yourself, Listen with empathy, Enhance self-esteem, Look for the good, with discernment, encourage diverse perspectives and Use courage and compassion to say what needs to be said).

3. Flexible in handling change, meeting a standard of excellence, persistent in pursuing goals despite obstacles and setbacks. Self-awareness of how behaviors can affect our colleagues. Keeping disruptive emotions and impulses in check, sensing other’s feelings and perspectives to advocate and voice opinions and viewpoints appropriately within and outside our company.

4. Independently motivated and works well with others.

5. Excellent communication skills (oral/written).

6. Excellent organizational skills.

7. Strong commitment to customer service. Excellent communication, strong analytical and conflict resolution ability.

8. Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook), e-mail and the use of the Internet.

If you're looking for a great opportunity apply now!

Questions? Contact Andie Veach at andie@carexscientific.com

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Carex Scientific's world-renowned partner in Madison, WI is currently seeking an innovative and industry-leading Director, Engineering to help assess, develop strategy and implement continuous best-in-class solutions that keep the company at the forefront of the biotech and life science industry. Individuals with strong process and automation engineering experience, as well as strength or exposure to packaging engineering, in the highly regulated biotechnology, pharmaceutical or similar life science industry that are looking to work on a breadth of projects from capital and equipment to vendor management will thrive in this role. If you're a serve-first leader that wants the leeway and ability to take your team and department where you best see fit and bring in resources to stay cutting-edge, this opportunity could be what you're looking for!

What You'll Do:

The Director, Engineering plans and directs all aspects of engineering (process engineering, automation engineering and packaging equipment engineering) activities within the organization. This individual is responsible for the design and implementation of manufacturing engineering plans and projects, quality requirements, and/or testing and troubleshooting systems. They will ensure all engineering projects, initiatives, and processes are in conformance with the organization's established policies and objectives. This individual will also ensure continuous improvement in process, cost, quality, and production. This group’s goal is to support the manufacturing and distribution of continued quality, innovative products.

Essential Duties:

What You'll Bring:

Preferred Qualifications:

Physical Requirements:

If you're looking for your next career step apply now!
Questions? Feel free to contact Ginger Auchter directly: ginger@carexscientific.com

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Senior Scientist / Orbitrap Mass Spectrometry Expert

Get in on the Ground Floor of a Fully Funded, Innovative Drug Discovery StartUp!

 

This is an exciting opportunity to join a fully funded, venture-backed startup whose mission is to accelerate the discovery of lifesaving therapeutics.

 

You’ll be joining a company that is a contract research organization that provides analytical research services for drug discovery, specifically targeting the $300 billion antibody therapeutics market. We’ve reduced analysis time from the industry standard of 6-12 months to only 2-3 weeks and are completely changing the market!

 

Our patented, cutting-edge technology has significant advantages over the existing technologies available in the market today. We have an established pipeline of pharmaceutical customers including big pharma, clinical-stage biotechnology companies and research institutions. We have assembled a talented group of PhD-level scientists, including leading experts in biochemistry, who are passionate about revolutionizing drug discovery to improve patient outcomes. 

 

What You’ll Do

Our Scientists at make an impact on day one. We are a fast-paced, entrepreneurial organization without the bureaucracy of a traditional life sciences business. As an early employee, you will collaborate with other top scientists to solve real-world customer problems to advance drug discovery. You will have the opportunity to shape the future direction of the organization and the potential to manage a team of scientists as the business grows.

 

Our Technology

Our founders developed a patented technology called Plasma Induced Modification of Biomolecules (“PLIMB”). PLIMB is a mass spectrometry-based technique for epitope mapping and protein structural analysis. Over the last 5 years, the NIH, NSF, WARF, and others have invested $1.4 million in PLIMB’s research and development, product development, and application testing. Our technology is customer-ready today and has been validated by pharmaceutical customers.
 

What You’ll Bring

·   Minimum 4+ years of experience and strong expertise in LC-MS protein analysis

·   Ph.D. in analytical chemistry, biochemistry, or related field 

·   Deep understanding and proven experience in LC-MS instrumentation and troubleshooting

·   Experience in proteomic LC-MS method development and analysis

·   Ability to work independently and collaborate with team members

·   Ability to identify bottlenecks and unmet needs in analytical characterization workflows and develop solutions for customers

·   Entrepreneurial mindset with interest in taking a leadership/management role

·   Exceptional time and project management skills with the ability to own and manage multiple projects in a changing environment and meet timelines

·   Excellent communication skills and ability to speak, present and write clearly and accurately

·   Willingness to travel to conferences and customer site visits

 

Additional Ideal Skills

·   Experience or understanding of the following techniques

oHydrogen/Deuterium Exchange (HDX):

oHydroxyl radical protein footprinting (HRF)

oChemical cross-linking mass spectrometry (XL-MS)

oSite-specific labeling MS

oGlycoprotein analysis with MS

oIn-silico structural modeling

oProtein expression and purification

oMembrane protein expression and purification

oMutagenesis

oSEC-MALS

oELISA

oProtein-protein interaction and in vitro binding assays

·   Experience and/or familiarity with in-silico protein structural analysis and visualization.

·   2+ years of industry experience, especially in the field of antibody drug discovery/development

·   Hands-on experience with Thermo Orbitrap technology

·   Familiarity with Protein Metrics software 

·   Business experience and interest

·   Demonstrated experience in developing strong customer relationships and project management

 

Overall Responsibilities

·   Lab and instrument design and setup

·   Develop and optimize HDX, HRF, XL-MS (and others as described above) experiments for the following applications:

oEpitope mapping

oProtein-protein and protein-small molecule interactions

oStructural analysis

·   Visualize complex proteomics datasets

·   Technical presentations to clients and at conferences

·   Manage customer projects

·   Author scientific papers

·   Write grant funding proposals 

·   Future potential of managing a team of analytical and biological chemists

 

This position is based in Madison, WI and includes a full relocation package for applicable candidates. Excellent compensation package includes salary, benefits package, stock options and performance bonuses (both cash and stock options).

 

If you’re looking to unleash your expertise and follow your dream of being on the ground floor of an amazing startup, contact us today! 

Questions? Email Ginger Auchter directly at ginger@carexscientific.com

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