Principal Scientist, Downstream Process Development
Ambrx is a biopharmaceutical company enabling a new field of protein medicinal chemistry, using a fundamentally new technology that directs incorporation of amino acids beyond nature’s conserved set into biosynthetic proteins to produce high value biologics products.
We are seeking an experienced senior level Scientist to be a key member of a dynamic and fast-paced organization. The successful candidate will provide hands-on leadership to develop stage appropriate downstream processes for clinical manufacturing of protein therapeutics. This individual will play an active role in process technology transfer, GMP manufacturing, and process characterization and validation activities at contract development and manufacturing organizations (CDMOs). Additionally, this individual will support regulatory submissions by authoring/reviewing relevant CMC sections for IND/IMPD and BLA. The successful candidate must be a goal-oriented team player with excellent troubleshooting and communication skills and adaptive to a timeline driven work environment.
- Ph.D in Biochemistry, Biochemical Engineering, or related field with 12+ yrs industry experience in developing protein/antibody purification processes to support programs from IND-enabling to commercialization. Experience with antibody drug conjugates is highly preferred.
- Experience in the following areas is required:
- Leading a team for downstream process development and protein production
- Working/managing CDMOs for technology transfer, process development, and GMP manufacturing, including document reviews (protocols, reports, manufacturing batch records)
- Performing or overseeing process characterization and process validation to enable BLA/commercialization
- Authoring relevant CMC sections for IND, IMPD, and BLA submissions and drafting responses to regulatory authority queries
- Technical expertise (both hands-on experience and in-depth knowledge) in the following subjects is required:
- Modern purification techniques for proteins and protein conjugates (chromatography, filtration (TFF and NFF), and conjugation)
- Programming and operating chromatography and TFF systems
- Column packing and evaluation at various scales
- Basic analytical techniques (i.e., gel electrophoresis, HPLC, UV-Vis, ELISA, etc.)
- Applying statistical tools (DOE and data analysis) for process development and characterization
- Must be self-motivated, 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.. 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