Overview
The Associate Director CMC Drug Substance works cross-functionally with internal and external teams to support drug substance (DS) GMP external clinical and commercial manufacturing, process technology transfer, process validation (PV), continuous process verification (CPV), preparing Module 3 of the CTD for commercialization of pipeline drug candidates while adhering to Good Manufacturing Practices, company policies and procedures.
Responsibilities
- Support process characterization and validation for commercialization of pipeline drug candidates.
- Support GMP external manufacturing of clinical or commercial biologics DS.
- Review Contract Development and Manufacturing Organization (CDMO) batch records, protocols, and reports. Lead/ support troubleshooting, process risk analysis and manufacturing investigations.
- Serve as a person-in-plant (PIP) to assist in management of CDMO activities.
- Lead technology transfer of pipeline drug candidates to external CDMOs.
- Support authoring Module 3 of the DS Common Technical Document (CTD) for regulatory submissions.
- Support Continuous Process Verification (CPV) program for commercial biologics manufacturing.
- Collaborate closely with internal and external cross-functional teams like analytical, formulation, quality assurance and regulatory to support batch release, manufacturing investigations, testing and stability programs.
Qualifications
- Master’s degree in Chemical Engineering, Biochemical Engineering, Biochemistry, Biological Sciences or science related field.
- 8+ years of progressive experience within biotechnology, pharmaceutical, or biologics manufacturing environments.
- 3+ years of experience in managing or working with biologics CDMOs.
- 2+ years of experience in working with late-phase biologics programs
- 2+ years of experience in authoring CMC technical writing
- Interpersonal skills to effectively manage internal and external communications.
- Able to travel 10-15 % of time.
- Proficient in the use MS Outlook, Word, Excel, Project, PowerPoint, Visio.
Compensation Statement
The expected base salary for this position is: $153616.00 to $199501.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.
