Job: 2022FR-04

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.  Ambrx is seeking a highly motivated Scientist to be a key member of a fast-paced and dynamic organization.

Job Summary

The candidate will be responsible for developing cell culture medium, feeding strategies, process parameter optimization, and scale-up to support R&D, large scale production, pre-clinical, and clinical activities. Participation in writing development reports, protocols, batch records and technology transfer will also be required.  This scientist should demonstrate strong scientific/technical and interpersonal skills as well as the ability to communicate effectively.  The candidate will apply biological and engineering expertise to develop recombinant protein production processes suitable for large-scale cGMP manufacturing and acts as a mentor for those with similar or less cell culture/engineering expertise, providing both technical expertise and leadership to understand potential career paths.  This job may require some travel to development partners and other manufacturing sites both in and outside the US.

Requirements:

  • PhD with 2+ or Master’s Degree with 8+ years industrial experience and a degree in Chemical Engineering, Biotechnology or related field.
  • Must have hands on experience in process development utilizing CHO cells to produce biologics using, shake flasks, 5L bioreactors, perfusion technology, Ambr15 and Ambr250 automated  bioreactor systems.
  • Knowledgeable in cell culture process scale-up and technology transfer to contract manufacturing organizations.
  • Must have a proven record of innovation and have the ability to apply scientific and engineering principles to solve complex problems.
  • A good understanding of cell physiology, metabolism, and cell biology
  • Ability to multitask and adapt in a fast paced environment and stay focused on project deliverables.
  • Work with minimum supervision in designing and executing experiments and analyzing data.

Additional Desired Experience and Skills:

  • Knowledge of Design of Experiments (DOE) and statistical analysis of data.
  • Working knowledge of GMPs and experience writing SOPs and batch records.
  • Medium/feed development experience for CHO cell culture
  • Experience with pilot scale bioreactors and primary recovery equipment.

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

Job: 2022FR-02

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 independent, experienced, and self-motivated Scientist to be a key member of the downstream process development group in a fast-paced, dynamic organization. The successful candidate will independently design, execute, and document laboratory studies supporting the research, development, and scale-up of therapeutic proteins from mammalian and microbial expression systems. The individual will develop phase‑appropriate purification processes for pre-clinical and clinical production and play an active role in technology transfer to support toxicology and clinical manufacturing at contract development and manufacturing organizations (CDMOs). Additionally, this individual must be a goal-oriented team player with excellent troubleshooting and communication skills and adaptive to a timeline driven work environment.

Job Requirements:

  • PhD/MS/BS in Biochemistry, Chemistry, Chemical Engineering, or related field with 2/6/10 years of industry experience in developing protein/antibody purification processes to support pre-clinical and clinical stage programs.
  • Experience in the downstream process development and scale-up of therapeutic proteins is required. Experience in antibody-drug conjugates (ADC) is highly preferred.
  • Hands-on experience and scientific knowledge of the following are required
    • Modern purification techniques for proteins and protein conjugates (chromatography, filtration (TFF and NFF), and conjugation)
    • Chromatography – affinity, IEX, HIC, and multi-modal
    • Programming and operating chromatography (ÄKTA) and TFF systems
    • Column packing and evaluation at various scales
    • Basic analytical techniques (i.e., gel electrophoresis, HPLC, UV-Vis, ELISA, etc.)
    • GMP manufacturing
  • Experience in process characterization, scale-up, and technology transfer to CDMO to support clinical manufacturing is highly desired.
  • Process development and optimization using statistical tools (DOE and data analysis) is a plus.
  • Proficient scientific writing skills, including protocols, reports, batch records, and regulatory filings (e.g., IND, IMPD, etc.).
  • 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 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

Job: 62-21BA

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 development of LC-MS/MS and ligand-binding assay pharmacokinetic (PK), anti-drug antibody (ADA), and cell-based neutralizing antibody (nAb) assays, in addition to managing GLP CROs for methods validation and non-clinical/clinical sample testing.

Job Responsibilities:

  • Independently develop small molecule LC-MS/MS and hybrid LC-MS/MS PK assays to support Ambrx’s programs from discovery to the clinic.
  • Work with TS team members to assess novel ligand bindings assay and immunogenicity assay formats and successfully develop PK, ADA, and cell-based nAb assays to support IND-enabling studies and clinical trials.
  • Request proposals, audit, and negotiate bioanalytical contracts with GLP CROs.
  • Work with TS team members to efficiently transfer and validate PK/immunogenicity methods to CROs within aggressive timelines.
  • Manage outsourced generation of antibodies for use as critical reagents in PK/ADA assays.
  • Author PK/TK/ADA 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 and collaborator meetings.
  • Perform PK parameter analysis using Phoenix WinNonlin software and interpret data.
  • Manage time and workload to meet project deliverables within aggressive deadlines.

 

Required Experience:

  • PhD with 5+ years experience (or MS with 10+ years experience) in the protein and small molecule bioanalytical field.
  • Demonstrated hands-on experience developing and validating small molecule LC-MS/MS and hybrid LC-MS/MS assays for quantification of PK samples; expertise in triple quad mass spectrometer systems.
  • Prior experience developing, transferring, and validating ligand binding PK assays and ADA assays for protein therapeutics using the MesoScaleDiscovery (MSD) platform.
  • Skilled in tissue culture techniques, developing cell-based nAb assays, and performing statistical analyses using JMP software (ex. outlier identification, cutpoint determination).
  • Knowledgeable in PK and immunogenicity regulatory guidances (USP, EP), bioanalytical white papers, and industry best practices.
  • Experience interviewing GLP CRO’s, conducting technical audits, negotiating quotes, and actively managing CROs to stay within the budget of quoted work.
  • Demonstrated capability to quickly troubleshoot data and identify solutions.
  • Prior experience working with ADCs, bispecific molecules, and PEGylated proteins.
  • Experience developing biomarker assays 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.

 

To be considered as an applicant, please submit your resume/CV referencing the specific position of interest 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

(Job: 47-21BA)

About Ambrx:

Ambrx is a clinical-stage biopharmaceutical company enabling a new field of protein medicinal chemistry, using a technology that directs the incorporation of amino acids beyond nature’s conserved set into biosynthetic proteins to produce high value biological products such as antibody-drug conjugates. Ambrx is seeking a highly motivated research associate to be a productive member of a fast-paced and dynamic organization.

Responsibilities:

This position will focus on upstream process development and support the efforts for developing and optimizing the cell culture process including medium development, feeding strategies, process parameter optimization, process characterization and scale-up for large scale production to support R&D, pre-clinical, and clinical activities.

  • The candidate will prepare materials for and set up designed experiments,
  • Collect and organize data.
  • Keeping careful records and attention to detail are critical.
  • Prepare CHO media and growing CHO (or other suspended mammalian) cells in shake flasks and bioreactors
  • Hands on use of Bio HT, Flex II (or Bioprofile 400), Vi-Cell, Ambr-15 or Ambr-250

Requirements:

  • MS with 2-6 yrs or BS with 2-8 industry experience Biochemical Engineering, Chemical Engineering, Biochemistry or related field
  • Hands-on experience with CHO or other mammalian cells for mAb or recombinant protein production is a must.
  • Hands-on experience using shake flasks and bioreactors is desired
  • Previous experience in cell culture scale-up, tech transfer including drafting development reports, production batch records, protocols and knowledge of scale-up and scale-down models is highly desired.
  • Knowledge of statistical design of experiments in process development and optimization
  • Previous experience in cell culture media development and cell culture platform development is a plus.
  • Previous experience in us of automated mini-bioreactor systems (Ambr15 or Ambr250) is a plus
  • The ability to succeed in a multidisciplinary, fast changing and diverse team environment

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.