The Director of CMC will work in a cross functional to support the various therapeutic programs for Progenity’s Precision medicine division.
- Carries out the formulation and process development of the company’s proprietary drug delivery products.
- Participates in process scale-up and manufacturing activities to provide quality materials for nonclinical and clinical trials.
- Evaluates and manages tech transfer with contract manufacturing organizations.
- Manages a global network of CMOs and CROs for development work related to small and large molecules.
- Maintains accurate lab notebooks and complete development reports.
- Authors and reviews relevant documents required to support IND and BLA regulatory submissions.
- Authors and reviews production batch records for the manufacturing of GMP materials.
- Cooperatively works with personnel in other departments and collaborators: Analytical Development, Quality Assurance and Regulatory Affairs, and collaborating partners.
- Identifies and evaluates new technologies for the company’s portfolio.
- Travels to various partner sites as needed.
This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as deemed necessary.
- PhD in pharmaceutics, industry pharmacy, biochemistry, chemical engineering, biomedical engineering or any equivalent major.
- Over 10 years of working experience in biotech or pharmaceutical companies with prior experience in small molecule and biologics formulation and process development.
- Experience managing a global network of CMOs and CROs for various development activities.
- Prior experience with medical devices or combination products highly desirable.
- Good knowledge and understanding of cGMP regulations and ICH guidelines.
- Excellent verbal and written communication skills; capable for writing reports and analytical methods.
- Team player with ability to positively communicate with team members.
- Must be highly organized and able to work independently in a fast-paced environment.
- Must be professional, dedicated, detail-oriented, and self-motivated.
- Proficiency with word-processing, spreadsheet, chemical drawing, and basic statistical analysis (i.e. MS Word, Excel, ChemDraw, JMP etc.).