Associate Director, Drug Substance

Celldex; Hampton (NJ); On-site; USD 154,000 - 200,000; Full time

Job summary

Celldex is seeking an Associate Director for CMC Drug Substance to drive cross-functional support for GMP external manufacturing, technology transfer, and CTD Module 3 preparation for pipeline drug candidates.

The role emphasizes collaboration with analytical, formulation, QA and regulatory teams to ensure batch release, investigations and stability programs, while leading CDMO relationships and CPV programs. Expect travel and leadership across 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.

Responsibilities

• Support process characterization and validation for commercialization of pipeline drug candidates.
• Support GMP external manufacturing of clinical or commercial biologics DS.
• Review 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 CPV program for commercial biologics manufacturing.
• Collaborate with analytical, formulation, quality assurance and regulatory teams to support batch release, investigations, testing and stability programs.

Skills

Interpersonal skills

Travel readiness

Education

Master’s degree in Chemical Engineering or related field

Tools

MS Outlook

Word

Excel

Project

PowerPoint

Visio

Job description

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.