Formulation & Development Manager - HIGH VISIBILITY - New Drug Product Development/API/Encapsulation
Do you have a strong background in a pharma pilot plant setting working with encapsulated or tablet-based Drug Product Development? Want to build your own Program and work in a brand-new facility of a global Biotech leader with amazing Scientists and Engineers as colleagues? This Program Manager – Drug Product Development could be the perfect role for you!
What You'll Do:
The Program Manager – Drug Product Development is responsible for working closely with clients in Custom Products and supporting both their internal Drug Development activities, as well as working with outside contractors to move the products forward. This will include:
Driving multiple drug product development programs in conjunction with cross-functional project teams. The candidate will have a broad knowledge of regulatory, scientific, and technical issues concerning drug development applications in the USA, Europe, and other global markets.
Define, align scientific and regulatory strategy, manage, and execute drug product programs utilizing both external vendors and internal capabilities.
Work with external partners including CROs and CMOs and regulatory agencies.
Author and review technical documents in support of regulatory submittals and preparation of submission ready sections. Manage input with internal team of individuals, consultants, and SME’s as part of regulatory submission process.
Oversee CROs and CMOs as a technical expert and coordinate contract work to ensure projects adhere to established timelines and technical specifications.
Facilitate API and finished drug product (dosage form) development activities including biochemical and biophysical characterization, formulation development, and extractable/ leachable studies, etc.
Prepare presentations, organize meetings, and collaborate with other scientists and departments.
Identify issues that may delay timely completion of critical project tasks and escalate as needed.
Work cross-functionally and communicate effectively across functional areas and collaborate across the organization to help identify/develop new external development capabilities.
Lead projects/programs managed by the Product Launch and Change Planning (PLCP) function.
Provide understanding of cGMP and global regulatory requirements for drug product development and manufacturing.
Manage and resolve conflict within the project team. Lead cross-functional teams within Process Development across all modalities and across all commercialization stages as needed. Facilitate and incorporate lessons learned and standard methodologies.
Draft timeline scenarios to enable/adjust project execution across multiple development paradigms to inform portfolio decisions.
Play a critical role in the resource/financial management and forecasting of individual projects on an ongoing basis.
Demonstrate a continuous improvement mindset: proactively seek out, recommend, and implement process improvements.
Apply project management best practices in the initiation, planning, execution, control and closing of projects.
Understand and comply with ethical, legal, and regulatory requirements applicable to our business.
What You'll Bring:
Degree in pharmaceutical sciences, chemistry, chemical engineering, biology, or related sciences.
Minimum 10+ years industrial experience in a pharmaceutical setting with specific focus on drug product development.
Experience with methods for the biochemical and biophysical characterization of small and large molecules and dosage forms of various nature, including capsule and IM.
Excellent technical written and oral communication skills.
Good organizational skills and ability to meet challenging project deadlines among competing priorities.
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.