Associate Director, Drug Product Manufacturing
Location: (Position can be remote)
(Job: 2023-BN-13)
About Ambrx:
Ambrx Biopharma, Inc. (NASDAQ: AMAM) is a clinical-stage biologics company focused on discovering and developing a novel class of specific and selective engineered precision biologics, using our proprietary platform technology that allows site-specific incorporation of synthetic amino acids (SAAs) into proteins within living cells. Our product candidates are designed to overcome the inherent limitations of conventional conjugation approaches that use non-site-specific conjugation, in order to optimize for safety and efficacy benefits across multiple therapeutic classes in broad therapeutic areas.
We are seeking an experienced and highly motivated leader in drug product manufacturing to be a key member of the CMC team in a dynamic and fast-paced organization. The successful candidate will be responsible for overseeing drug product GMP manufacturing at contract development and manufacturing organizations (CDMOs) to authoring/reviewing drug product sections for regulatory submissions. Additionally, this individual must be a goal-oriented team player with excellent troubleshooting and communication skills and adaptive to a timeline driven work environment.
Major Responsibilities:
- Oversee drug product GMP manufacture and related activities at CDMOs, including timely review/approval of batch records and related manufacturing documents, manage tech transfer and production progress at the CDMO, help to troubleshoot any issues related to drug product manufacture and release, and serve as the person-in-plant for manufacturing activities.
- Author and review drug product sections for regulatory submissions, including original IND/IMPD, IND/IMPD amendments, BLA, and response to queries from global regulatory authorities.
- May manage formulation development and drug product process development (including lyophilization cycle development) at CDMOs.
- Proactively identify potential problems or opportunities in CMC areas to facilitate advancement of product candidates.
Job Requirements:
- PhD/MS/BS in Biochemistry, Chemical Engineering, or related field with 12+ years of experience in biopharmaceutical industry.
- Hands-on experience working in a cleanroom environment and in drug product manufacturing of biologics.
- Experience and knowledge in the entire drug product manufacturing process, from drug substance thawing and compounding, sterile filtration, filling, stoppering, lyophilization, capping, to visual inspection and labeling.
- Familiar with filtration systems, filling lines, filling isolators, and environmental monitoring.
- Experience in CDMO management and working closely with the Quality Assurance and Clinical Supply Chain Management functions.
- Experience in risk management, deviation and root-cause investigations and CAPAs.
- Experience in writing CMC sections of IND.
- Experience in antibody drug conjugate (ADC) manufacturing is highly preferred.
- Experience in formulation development, lyophilization cycle development, drug product process characterization and validation, equipment validation, and cleaning validation are highly desired.
- Must be proactive, detail-oriented, collaborative, and able to work effectively in a fast-paced environment with minimal supervision.
- Excellent communication, organization, and collaborative skills are essential.
To be considered as an applicant, please submit your resume/CV referencing the specific position of interest and position code to careers@ambrx.com. Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensation & benefits. EOE