(Job 2023BR-08)

 

About Ambrx:

Ambrx (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.

Ambrx is seeking a highly motivated Research Associate to join the Discovery Group. The primary responsibility is to support multiple oncology and immune-oncology projects from discovery to the preclinical phase. The candidate will work in a multidisciplinary and dynamic team environment to help with discovery and develop precision engineered biological drugs that change patients’ lives.

Major Responsibilities:

  • Work in the Discovery Group to support multiple discovery projects to expand Ambrx’s early pipeline
  • Build DNA constructs for various formats of biological therapeutics
  • Collaborate seamlessly with cell culture group to quickly deliver protein material for discovery projects
  • Generate recombinant stable cell lines for assay development and preclinical animal models
  • Develop and perform in vitro biological assays to characterize drug candidates

Job Requirements:

  • MS degree with 0-4 years of experience, or BS degree with 2-4 years of experience, in the biotech and /or pharmaceutical industry
  • Prior experience or good knowledge in molecular biology, especially in cloning, PCR, and vector construction
  • Prior experience or good knowledge in recombinant protein expression in a wide variety of systems (bacterial, mammalian cells)
  • Prior experience in aseptic tissue culture, in vitro biological assays, ELISA desirable
  • Prior experience working with oncology and immune-oncology therapeutic proteins and translational science is a plus
  • Demonstrated passion to learn and advance new technology
  • Ability to work independently and collaboratively in a matrixed team environment
  • Good oral/ written communication and strong problem-solving skills

Pay Scale:

The pay scale for this position is annualized at: $ 65,000 to $ 80,000, 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 for this opportunity, please submit your resume/CV referencing the position code to careers@ambrx.com. Applicants whose qualifications and experiences most closely match the requirements will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensations & benefits. EOE.

(Job: 2023-BR-07)

 

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 scientific leader to be a key member of a fast-paced and dynamic organization.

Job Description:

Responsibilities:

This position will focus on upstream process development and lead 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. This individual will design and carry out experiments and provide technical leadership and serve as the subject matter expert on project teams and work closely with other groups to provide support for the Company’s projects. The candidate will monitor, explore and evaluate next generation technologies to speed up process development. This individual will also be responsible for technology transfer to third parties including partners and CMO.. The role will involve authoring of development reports and CMC sections for regulatory submissions including INDs and BLAs.

Requirements:

  • Ph.D with 12+ yrs industry experience or MS with 16+ yrs industry experience in Biochemical Engineering, Chemical Engineering, Biochemistry or related field
  • Hands-on experience with CHO and other mammalian cell for mAb or recombinant protein production is a must
  • Hands-on experience using spin tubes, shake flasks, stirred tank bioreactors, automated microbioreactor systems and ATF equipemnt is required
  • 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 plus
  • The ability to succeed in a multidisciplinary, fast changing and diverse team environment
  • Working knowledge of GMP and experience with US IND/BLA filings are highly desirable

Pay Scale:

The annualized pay scale for this exempt position is: $145,000 to $175,000, 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 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

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