Associate Director, Drug Substance

Celldex Therapeutics, Inc.; Hampton (VA); On-site; USD 154,000 - 200,000; Full time

Job summary

Celldex Therapeutics, Inc. seeks an Associate Director CMC Drug Substance to drive process characterization and transfer for pipeline candidates. The role collaborates across analytical, formulation, QA, and regulatory teams to ensure robust manufacturing for clinical and commercial programs.

You will manage external CDMOs, oversee batch records, and author CTD Module 3 documentation, while enabling CPV programs and continuous improvements in manufacturing.

Qualifications

• Master's degree in a relevant field.
• 8+ years of progressive experience in biotechnology, pharmaceutical, or biologics manufacturing.
• 3+ years of experience with biologics CDMOs.
• 2+ years of experience in working with late-phase biologics programs.
• 2+ years of experience in authoring CMC technical writing.
• Ability to travel 10-15% of time.
• Strong interpersonal and cross-functional collaboration skills.

Responsibilities

• Support process characterization and validation for commercialization of pipeline drug candidates.
• Lead/ support GMP external manufacturing of clinical or commercial biologics DS.
• Review CDMO batch records, protocols, and reports; lead troubleshooting and investigations.
• Serve as a person-in-plant (PIP) to assist in CDMO activity management.
• Lead technology transfer of pipeline drug candidates to external CDMOs.
• Support authoring Module 3 of the DS CTD for regulatory submissions.
• Support CPV program for commercial biologics manufacturing.
• Collaborate with analytical, formulation, quality assurance and regulatory teams for batch release and stability programs.

Skills

Biologics

Project management

Cross-functional communication

Regulatory writing

Education

Master's degree in Chemical Engineering, Biochemical Engineering, Biochemistry, Biological Sciences or science related field

Tools

MS Office Suite (Outlook, Word, Excel, Project, Visio)

Job description

About Celldex

Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. We have built a culture where innovative and talented people thrive- focusing a significant effort on attracting and retaining passionate and motivated employees who want to play a role in helping people with serious health conditions and who see this effort as personally rewarding. In our highly entrepreneurial environment, employees are empowered and the opportunity for professional development occurs every day.

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.