Job: 57-21BA

About Ambrx:
Ambrx, Inc. is a biopharmaceutical company with a mission to deliver breakthrough protein
therapeutics. Ambrx is based on a fundamental advance in protein biosynthesis that enables the
company to genetically engineer proteins with new amino acid building blocks beyond the common
twenty, enabling the biosynthesis of proteins with new physical, chemical and pharmacological
properties. At Ambrx, we are dedicated to assembling and developing an exceptional team and a
breakthrough technology to create the next generation of protein-based medicines.

KEY RESPONSIBILITIES
• Independently design and perform in vitro binding and cellular assays to assess drug
candidate cytotoxic and/or immunomodulatory effects
• Analyze and interpret experimental results and present findings at project team meetings
• Provide technical expertise to project teams for functional assay development,
immunoassay design, flow cytometry, and/or other specialized techniques
• May support management of external studies with CROs and/or collaborators
• Maintain detailed records in laboratory notebooks in accordance with company policy
• Contribute to writing of technical reports, SOPs, patent applications, and scientific
manuscripts for publication

PROFESSIONAL EXPERIENCE/QUALIFICATIONS
• B.S. in Biology/Biochem or similar + 6 years industry experience; or M.S. + 4 years industry
experience
• Consistent track record of rigorous in vitro agonist/antagonist study design, including
appropriate controls, benchmarks, dose responses, variability, reproducibility, etc.
• Deep experience performing in vitro functional assays using cell lines and primary human
immune cells (e.g. cytotoxicity, immune-tumor cell co-culture, immune activation)
• Independent proficiency in diverse laboratory techniques, including cell culture, flow
cytometry, ELISA/MSD/HTRF/etc, and primary human immune cell isolation
• Demonstrated ability to analyze complex data sets and concisely and communicate results
• Excellent organizational, time-management, and multi-tasking skills
• Consistently uses analytical thinking, persistence, and creativity to overcome challenges
• Demonstrated ability to deliver decision-making data sets within a matrixed organization
• Excellent verbal and written communication and interpersonal skills

How to Apply
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 position requirements will be contacted for further evaluation. Ambrx offers
competitive compensation & benefits. EOE

Job 56-21BA

About Ambrx:

Ambrx, Inc. is a biopharmaceutical company with a mission to deliver breakthrough protein therapeutics. Ambrx is based on a fundamental advance in protein biosynthesis that enables the company to genetically engineer proteins with new amino acid building blocks beyond the common twenty, enabling the biosynthesis of proteins with new physical, chemical and pharmacological properties. At Ambrx, we are dedicated to assembling and developing an exceptional team and a breakthrough technology to create the next generation of protein-based medicines.

KEY RESPONSIBILITIES

  • Independently contribute to drug discovery project planning, advancement, and leadership
  • Design and perform in vitrobinding and cellular assays to assess drug candidate effects on innate and adaptive immune functions
  • Analyze and interpret experimental results and present findings at project team meetings
  • Provide subject matter expertise to diverse project teams related to basic immunology, immuno-oncology, target biology, and disease pathogenesis
  • Use competitive intelligence, analytical thinking, and domain expertise to develop new project proposals
  • Support and manage external collaborations, including CROs and collaborators
  • Desirable: may contribute to design and execution of in vivopharmacology models
  • Manage daily activities and professional development of one or more Research Associates
  • Maintain detailed records in laboratory notebooks in accordance with company policy
  • Write and review technical reports, SOPs, and scientific manuscripts for publication

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

  • PhD degree in Immunology (or Mol/Cell Biology/Biochem with immunology expertise)
  • For Sr. Scientist: 5+ years of industry drug discovery experience
  • Deep understanding of human immunology and immuno-oncology field
  • Experience designing and performing in vitro assays using cell lines and primary human immune cells, including multi-step stimulation and immune-tumor cell co-culture systems
  • Skilled in standard immunological, and cell biology techniques including flow cytometry, ELISA/MSD/HTRF/etc, and primary immune cell isolation and culture
  • Experience with in vivo pharmacology systems is preferred
  • Demonstrated ability to organize and communicate complex data sets concisely
  • Excellent organizational, time-management, and multi-tasking skills
  • Consistently uses analytical thinking, persistence, and creativity to overcome challenges
  • Demonstrated ability to progress projects within a complex, matrixed, organization
  • Excellent verbal and written communication and interpersonal skills

 

How to Apply

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 position requirements will be contacted for further evaluation. Ambrx offers competitive compensation & benefits.  EOE

 

(Job 54-21BA)

Ambrx is a clinical-stage biopharmaceutical company with a mission to deliver breakthrough protein therapeutics through our proprietary technology. Unlike conventional conjugation technologies that creates a mixture of suboptimal molecules, Ambrx technology incorporates non-natural amino acids beyond the common twenty into the protein biosynthesis, enabling site specific conjugation of payloads, pharmacokinetic extenders with proteins to create novel homogenous molecular species that is optimized for safety, efficacy and biophysical properties.

Ambrx is seeking a highly motivated and dedicated Associate Scientist to be a key member of the In Vivo – Pharmacology team in a fast-paced and dynamic environment. This position will be responsible for conducting in vivo pharmacology experiments.

Major Responsibilities:

  • Independently conduct rodent in vivo pharmacology experiments, including but not limited to initiating, maintaining, and evaluating oncology models, including model development, dosing for PK/PD relationships and efficacy studies – with blood sampling, and tissue/tumor collection endpoint analysis for FACS analysis, IHC etc.
  • Author study reports in a timely manner and assist in maintaining and organize report repository.
  • Effectively present experimental data with concise results to guide drug development at organizational meetings.
  • Work as part of a collaborative team to design, plan and execute experiments that support research activities.
  • Assist in IACUC documentation preparation and renewal and vivarium compliance.
  • Interface with external laboratories for testing and sample analysis when required.

 

Job Qualifications:

  • BS/MS with 3+ years related experience.
  • Highly skilled in various methods of dosing (SC, IP, IT, PO, and IV) and blood collection (RO, tail vein, and cardiac puncture) in mice primarily, but occasional rat studies.
  • Strong experience in tumor measurements by caliper, body weighing, and health monitoring. Must be experienced with precise dosage calculations for in vivo efficacy studies.
  • Familiarity in harvesting and disaggregating tissue / tumor for subsequent ex vivo analysis – experience with multi-color FACS analysis a plus.
  • Familiar with software including Graph Pad, Microsoft office etc. for data analysis and data summary and presentation.
  • Adaptive and a quick learner, efficient in multitasking, highly organized and excellent record keeping.

 

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 experiences most closely match the requirements will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensation & benefits. EOE.

 (Job 36-21BA) 

Ambrx Inc., is a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code. Ambrx technology uses an expanded genetic code to incorporate synthetic amino acids into protein, all completed within a living cell. These synthetic amino acids enable the creation of Precision Biologics, an exciting new class of therapeutics with broad application and potential. This includes next-generation antibody drug conjugates (ADCs), bispecifics, and targeted immuno-oncology therapies for cancer as well as smart cytokines to modulate the immune system, and long-acting therapeutic peptides for metabolic and cardiovascular disease. 

Ambrx is seeking 2 highly motivated Senior Research Associates 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 4+ years of experience, or BS degree with 6-8 years of experience, in the biotech and /or pharmaceutical industry 
  • Expertise in molecular biology, especially in cloning, PCR, and vector construction 
  • Expertise in recombinant protein expression in a wide variety of systems (bacterial, mammalian cells) 
  • Excellent skills in aseptic tissue culture, in vitro biological assays, ELISA 
  • Hands-on experience in FACS based assays 
  • Prior experience in stable cell line generation and assay development is desired 
  • 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 

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. 

(48-21BA)

Ambrx is a clinical-stage biopharmaceutical company enabling new field of protein medicinal chemistry using an expanded genetic code to produce high value biological products such as long-acting proteins, antibody drug conjugates and bi-specific antibodies.

Ambrx is seeking a highly motivated research scientist to join the Targeted Biologics Development Team. The main job responsibility is to express engineered proteins to support multiple oncology and immune-oncology projects from discovery to preclinical phase. The candidate will work in a multidisciplinary and dynamic team environment to help with the discovery and development of precision engineered biological drugs that change patients’ lives.

Primary Responsibilities:

  • Support multiple discovery projects both intellectually and experimentally 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

Requirements:

  • PhD degree in biology/biochemistry or related discipline with 1-3 years of drug discovery experience in the biotech and /or pharmaceutical industry
  • Expertise in molecular biology, especially in cloning, PCR, and vector construction
  • Expertise in recombinant protein expression in a wide variety of systems (bacterial, mammalian cells)
  • Excellent skills in aseptic tissue culture, in vitro biological assays, ELISA
  • Hands-on experience in FACS based assays
  • Prior experience in stable cell line generation and assay development is desired
  • 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

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.

(46-21BA)

Ambrx is a clinical-stage biopharmaceutical company enabling new field of protein medicinal chemistry using an expanded genetic code to produce high value biological products such as long-acting proteins, antibody drug conjugates and bi-specific antibodies.

We are seeking a highly creative and motivated organic/medicinal chemist to be a key member of dynamic research organization. The successful candidate will be part of a growing chemistry team who can contribute to discovering novel protein therapeutics to help patients in need.

Primary Responsibilities:

  • The successful candidate will support our small molecule, linker, and peptide synthesis needs
  • Carryout structure-activity relationship studies delivering high quality material for biological testing
  • Interpret experimental results such as in vitro/in vivo data to support new compound design and SAR
  • Carryout analytical and preparative method development to support internal chemistry needs
  • Collaborate and interface with other functional areas including analytical, biology and pharmacology to facilitate development and execution of project plans
  • Communicate research findings to the key stake holders and present in project meetings/conferences
  • Contribute to patent application writing and research reports
  • Identify and establish working relationships with CROs and manage external chemistry resources
  • Safe keeping and operation of lab and lab equipment

Qualifications:

  • Ph.D. in organic/medicinal chemistry or related field with minimum 2-6 years of post-doctoral/industry experience
  • Proven track record in drug discovery and demonstrated success in Hit/Lead identification and optimization, and carrying out SAR studies
  • Experience in structure-based and pharmacophore-based drug designs
  • Experience in modern synthetic organic chemistry techniques, designing new synthetic routes for complex molecules and carrying out multi-step synthesis of biologically active molecules
  • Hands-on experience with analytical and purification equipment HPLC, LC-MS and NMR etc.
  • Experience working with antibody drug conjugates is a plus
  • Must have strong presentation skills
  • 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.

(Job: 55-21BA)

Ambrx®, Inc. is an established biopharmaceutical company with a mission to deliver breakthrough protein therapeutics using an expanded genetic code. Unlike conventional conjugation techniques that create a mixture of suboptimal molecules, Ambrx technology combines site specific conjugation with proprietary linkers, payloads, and pharmacokinetic extenders to create a single molecular species that is optimized for safety, efficacy, and biophysical properties. We call this process Protein Medicinal Chemistry™.

The successful candidate will be a leader in analytical and product development for projects from IND to BLA stages, especially at late phase CMC development.  As a senior member of this function, this individual should be able to maintain high standards of technical and quality excellence and will mentor and manage scientists and associates.

Major Responsibilities:

  • Lead the efforts in developing and managing life cycle of analytical methods, ensuring that the projects are progressing timely as planned, process and products meet quality and regulatory requirements.
  • Oversee biologics method optimization, qualification and validation at CDMOs and internal activities to ensure methods are scientifically sound and robust.
  • Provide process development support and assist with setting in-process and batch release specifications.
  • Provide analytical and formulation optimization/robustness study support, and oversight for PC/PV and manufacturing of mAbs, drug substance and drug product.
  • Oversee raw materials testing, extractable and leachable studies; batch release and stability studies for mAbs, ADC/protein conjugates, and drug products; Reference Standards preparation and qualification.
  • Oversee Comparability studies and clinical in-use Compatibility studies.
  • Assist in gap analysis of CMC activities for BLA and develop plans to de-risk and manage studies to address the gaps.
  • Write/diligently review development reports, SOPs, Test Methods, qualification and validation protocols and reports, etc.
  • Author relevant CMC sections of IND, CTA, and BLA.
  • Provide expertise, technical leadership, and assessment of product quality impacting OOS and OOT investigations.
  • Participate in project teams to provide analytical support and coordinate resources for ongoing and new projects, from research to clinical stages.

 

 

Job Requirements:

  • Ph.D. in Analytical Chemistry or related field with 12+ yrs. of relevant experience in analytical development and characterization of protein therapeutics.
  • 5+ years of demonstrated leadership in staff and project management including Ph.D. Scientists/Senior Scientists.
  • Essential hands-on experience and in-depth knowledge in instrumentation and modern analytical chemistry techniques (HPLC assays, CE, peptide mapping, process residuals, and Compendial assays).
  • Extensive experience with assay development, qualification, validation and tech transfer to CDMO to support early and late-stage development for proteins, protein conjugates, antibodies, and antibody-drug conjugates.
  • Experience with PTM characterization, CQA risk assessment, and biophysical assays is a plus.
  • Experience with stability data evaluation, statistical analysis, DOE studies, and shelf-life projection preferred.
  • Experience in GMP-compliance and Quality/Regulatory Assurance.
  • Clear understanding of phase-appropriate regulatory requirement in CMC with significant experience in supporting late phase clinical development and commercialization, including authoring relevant CMC sections for IND, IMPD/CTA, and BLA submissions.
  • Demonstrated ability to set clear and measurable goals for staff and prioritize tasks and resources to achieve superior work quality and efficiency.
  • Excellent presentation, oral and written communication skills, be able to communicate effectively to senior management, cross-functional teams, and collaborators.

 

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.

(Job Code: 52-21BA)

About Ambrx:

Ambrx Inc., is a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code. Ambrx technology uses an expanded genetic code to incorporate synthetic amino acids into proteins, all completed within a living cell. These synthetic amino acids enable the creation of Precision Biologics, an exciting new class of therapeutics with broad application and potential. This includes next-generation antibody drug conjugates (ADCs), bispecifics, targeted immuno-oncology therapies, immunomodulatory smart cytokines, and long-acting therapeutic peptides for metabolic and cardiovascular disease.

We are seeking a highly motivated Director of CMC Project Management to be a key member of a fast-paced and dynamic organization.

Overall Responsibilities:

The Director of CMC Project Management will manage and support CMC development plans for multiple programs from IND to BLA, to ensure successful execution of program goals. He/she will cover multiple functional areas, including Process Development, Analytical and Formulation Development, CDMO management, Technology Transfer, Clinical Manufacturing, Quality, Validation, and Global Regulatory Filing of CMC Sections. He/she will also be responsible for internal communications, including status reports, risk management, and escalation of issues to cross-functional stakeholders and senior management.

Specific Responsibilities:

  • Establish and manage CMC development plans that align with company and program goals, including scenario planning to support decision-making and budgeting process.
  • Serve as primary CMC project management contact with contract development and manufacturing organizations (CDMOs), ensure clear and effective communications, and manage the relationships and activities.
  • Ensure functional leads have clearly defined project scopes, deliverables, and timelines, assist proactively to align with clinical development plans and facilitate team discussions to meet objectives.
  • Follow-up on issues and actions, ensure external and internal deliverables are met.
  • Identify gaps and risks, develop mitigation plans; enlist key people to resolve obstacles.
  • Drive the CMC document preparation and organization process for regulatory filings.
  • Coordinate subteam activities as required and ensure activity owners are completing assigned project tasks.
  • Maintain primary responsibility for CMC team meetings, including scheduling, preparation of agendas and minutes, action items, generate Gantt charts/Smart Sheets and actively track deliverables.
  • Ensure CMC related documents are well organized on SharePoint.
  • Prepare regular and ad hoc updates for senior management.

Qualifications:

  • BS or BA in a scientific discipline required; an advanced degree or PMP certification preferred.
  • 15+ years of experience in pharmaceutical/biotechnology industry with first-hand understanding of biopharmaceutical development process.
  • 8+ years of experience leading multi-disciplinary development teams in the execution of operational plans.
  • Solid understanding of technology transfer, clinical manufacturing, process development, analytical development, quality control, validation, and CMC regulatory documentation.
  • Technical experience in Process Development, Analytical and Formulation Development, or Manufacturing mAbs and complex Protein-conjugate therapeutics preferred.
  • Late-stage drug development and BLA experience preferred.
  • Knowledge of Quality systems and Regulatory guidance in an FDA regulated industry.
  • Experience with CDMO management.
  • Proven ability to manage cross-functional project teams and handle multiple projects at a time.
  • Excellent organizational and communication skills.
  • Strong interpersonal and leadership skills, excellence in building and managing relationships, ability to understand all perspectives, find common ground, and effectively bridge significant differences.
  • Detail-oriented while also maintaining the ability to see the big picture.
  • Demonstrated problem solving skills.

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