(Job Code: 2023-BN-01)
Ambrx is a biopharmaceutical company enabling a new field of protein medicinal chemistry, using an innovative technology that directs incorporation of amino acids beyond nature’s conserved set into biosynthetic proteins to produce high value biologics products.
Ambrx is seeking a highly motivated, senior-level scientist to be a key member of the Translational Sciences (TS) team. The successful candidate will be primarily responsible for developing ligand-binding assay (LBA), small molecule LC-MS/MS, and hybrid LC-MS/MS pharmacokinetic (PK) assays; developing anti-drug antibody (ADA) and cell-based neutralizing antibody (nAb) assays for immunogenicity testing; and managing GLP CROs for methods transfer/validation and clinical sample testing support.
- Independently develop novel ligand binding assays (LBA) and immunogenicity assays (ADA, nAb) to support research projects, IND-enabling studies, and clinical trials.
- Collaborate with research CRO’s to develop small molecule LC-MS/MS and hybrid LC-MS/MS PK assays to support Ambrx’s programs from discovery to the clinic.
- Perform PK parameter analysis using Phoenix WinNonlin software and interpret data.
- Request proposals, audit, and negotiate bioanalytical contracts with GLP CROs.
- Work with TS team members to efficiently transfer and validate PK and immunogenicity methods to CROs within aggressive timelines.
- Manage the outsourced generation of antibodies for use as critical reagents in PK and immunogenicity assays.
- Author PK/TK/immunogenicity study reports and nonclinical summaries for regulatory filings.
- Provide technical guidance to junior scientists on the TS team.
- Effectively communicate study results and timeline updates at internal project team meetings.
- Proactively manage time and workload to meet project deliverables within deadlines.
- D with 5+ years experience (or MS with 10+ years experience) in the protein and small molecule bioanalytical field.
- Hands-on experience developing LBA and ADA assays for protein therapeutics using the MesoScaleDiscovery (MSD) platform.
- Experience working with CROs or independently developing small molecule LC-MS/MS and hybrid LC-MS/MS assays for quantification of small molecule PK samples.
- Successful track record of transferring and validating PK and immunogenicity assays at GLP CROs
- Demonstrated capability to quickly troubleshoot data and identify solutions.
- Trained in use of Phoenix WinNonlin software to calculate PK parameters.
- Skilled in tissue culture techniques, developing cell-based nAb assays, and performing statistical analyses using JMP software (ex. distribution analysis, cutpoint determination).
- Knowledgeable in PK and immunogenicity FDA/EMA regulatory guidances, bioanalytical white papers, and industry best practices.
- Experience interviewing GLP CRO’s, conducting technical audits, negotiating quotes, and actively managing CROs to stay within budget of quoted work.
- Prior experience working with ADCs, bispecific molecules, or PEGylated proteins.
- Experience developing biomarker assays or managing drug metabolism studies is a plus.
- Previous supervisory experience.
- Ability to work collaboratively in a goal-oriented, fast-paced, matrixed team environment.
- Attention-to-detail, organizational skills, and strong written and oral communication skills are required.
The pay scale for this position is: $115,000 to $155,000, commensurate with experience. We believe this to be possible compensation for this role at the time of this posting, and we may modify this pay scale in the future.
To be considered as an applicant, please submit your resume/CV referencing the specific position of interest to firstname.lastname@example.org 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