Job: 76-21BA

Ambrx is a clinical-stage biopharmaceutical company enabling next generation protein therapeutics using an expanded genetic code to produce high value biologics such as long-acting proteins, antibody drug conjugates (ADCs) and bi-specific antibodies. At Ambrx, we are dedicated to assembling and developing an exceptional team and a breakthrough technology to create next generation protein therapeutics.

Ambrx is seeking a highly creative and motivated organic/medicinal chemist with project leadership skills to 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 lead internal/external programs and cross-functional teams to execute project plans
  • Lead our ADC, payload, linker, peptide design strategies and synthesis
  • Independently carryout structure-activity relationship studies and interpret experimental results to propose new compound designs
  • Proven ability to initiate new programs and understanding of biology concepts to deliver proof-of-concept data to make Go/No Go decisions
  • Proven ability to identify problems and propose solutions to move programs forward
  • Carryout analytical and preparative method development to support internal chemistry needs
  • 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:

  • PhD. in organic/medicinal chemistry or related field with minimum 8-12 years of industry experience
  • Experience working with antibody drug conjugates and understanding of ADC field is a requirement
  • Proven track record in ADC project leadership and demonstrated success in payload identification/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 biologically active molecules and carrying out multi-step synthesis in milligram to multi-gram scale
  • Hands-on experience with analytical and purification equipment including HPLC, LC-MS and NMR
  • Experience working with small molecule CDMOs and contributing to CMC section writings is a plus
  • Excellent presentation skills, 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: 75-21BA

About Ambrx:

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 Description:

  • Lead the cell line development (CLD) group to optimize CLD process to further improve efficiency and shorten timeline.
  • Improve transient expression titer of mAb or other therapeutic proteins to quickly provide gram of material for discovery projects.
  • Collaborate seamlessly with cell culture group to deliver production cell lines for GMP manufacturing and to develop platform batch/fed batch cell culture process.
  • Represent CLD function to participate internal and external project meetings, provide scientific insights and contribute to regulatory filings.
  • Mentor and manage junior scientists and maintain instruments in cell culture laboratories.

Requirements:

  • PhD molecular biologist or biochemist with 6+ years’ of Quality Control experience or MS with 8+ years’ of Quality Control experience in the biotech and/or pharmaceutical industry. PhD molecular biologist or biochemist with 6+ years’ of Quality Control experience or MS with 8+ years’ of Quality Control experience in the biotech and/or pharmaceutical industryCell biologist or molecular biologist with the degree of PhD with 5 years or MS with 8 years or BS with 10+ years of experience in the biotech and/or pharmaceutical industry.
  • Expertise in recombinant protein expression in a wide variety of systems (bacterial, mammalian cell lines) in industry setting.
  • Proven track record in industry-relevant mammalian expression system (CHO, HEK293 et al) using transient, stable bulk pool format as well as GMP stable cell line development and cell line engineering.
  • Knowledge and hands-on experience in general molecular biology, especially in cloning, PCR and vector construction.
  • Excellent hands-on skills in aseptic tissue culture, ELISA, HPLC, Octet.
  • Working experience in cell culture ranging from microplates, deep-well plates to shake flask. Knowledge and hands on experience in wave bag is a plus.
  • Skills in operation and maintenance of imager, cell counter, multitron, wave bag.
  • Skilled in writing cell line related technical report for tech transfer and regulatory filing.
  • Demonstrated passion to learn and advance new technology.
  • The ability to succeed in a multidisciplinary and dynamic team environment.
  • Independent thinking and team player. Experience in training and leading junior scientists is a plus.
  • Good communication and strong problem-solving skills

 

 

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: 73-21BA)

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.

Job Description:

In partnership with Contract Research Organization, the Clinical Quality Assurance Director will support the establishment, implementation and management of the quality assurance strategy across multiple studies. The CQA Director will assure adherence to Good Clinical Practice (GCP) in the conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients.

This role is accountable for GCP and/or Pharmacovigilance (PV) oversight, and for assuring the compliance of studies with applicable worldwide regulations and guidelines (e.g., United States FDA, European Union Directives, ICH, and National regulations).

Primary Responsibilities include but not limited to:

  • Provide GCP compliance advice and guidance to project teams, to achieve continuous quality improvement and effective quality management.
  • Interface with relevant stakeholders, including regulatory, clinical operation and clinical development to provide GCP expertise.
  • Prepare and conduct QA audits, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders, and interact with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
  • Proactively identify, analyze and leverage quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to promote the implementation of associated risk mitigation strategies.
  • Lead the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements).
  • Participate in the development/enhancement of QA procedures, guidance documents and audit tools.
  • Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents,
  • Act as a strong technical resource and is called upon to resolve GCP/PV issues based on knowledge of GCP, PV regulations and guidelines as well as local regulations.

Job Requirements:

  • BS/BA degree in a relevant area with 8+ years (Director) or 6+ (Associate Director) of experience in the pharmaceutical industry in a QA role.
  • Extensive vendor and site audit experience.
  • Excellent interpersonal skills, with ability to interact effectively and work efficiently with people at all levels in an organization.

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: 74-21BA)

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 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.

Job Description:

We are seeking a highly motivated and experience Quality Assurance Document Control Manager to join our fast paced and growing Quality Team. The QA Document Control Manager will manage documents (both electronic and paper copies) within Quality Assurance, Regulatory Affairs, Clinical and other key departments to ensure that all GxP regulated documents are filed systematically and are easily retrievable. The candidate is primarily responsible for the implementation, management and maintenance of the document management system in accordance with the Quality System and relevant regulatory requirements. This position is also responsible for training staff on document control processes and procedures. In addition, the QA Document Control Manager will manage both paper and electronic records to ensure that controlled records are created, identified, changed, reviewed, retained, stored, and maintained in a manner that meets requirements.

Essential Duties and Responsibilities (including, but are not limited to):

  • Receive, file, and maintain all GxP documents, including but not limited to standard operating procedures (SOPs), test methods, specifications, incident reports, CAPAs, computer system validation, …etc.
  • Assist in the selection and implementation of an electronic quality management system (eQMS).
  • Manage a Document Repository that tracks the receipt, revisions and archiving of all GxP documents; and prepare supportive process workflows and procedures to maintain efficiency and access for all users.
  • Maintain GxP audit files and assist with entry, tracking, and archiving of audit records.
  • Oversee and administer document lifecycle management as well as the change request process.
  • Assist in the maintenance of training records and documentation within our system.
  • Assist with and/or write SOPs for the creation and development of processes, archiving, and operations related to Document Control and other functions.
  • Perform review of documents submitted through the change control process for format, completeness, review and approvals.
  • Provide guidance and training to staff regarding document control processes.
  • Maintain overall document control structure within the document management system.
  • Define and maintain user roles and permissions in the document management system.
  • Resolve electronic document management system problems and issues in collaboration with users, system vendors and IT.
  • Support development of system and process improvements that would enhance compliance to documentation/training requirements.

 

Job Requirements:

  • Bachelor’s degree in Science or similar required.
  • >4 years of experience in a regulated environment and experience in managing and administering document control systems.
  • Knowledge of quality systems and regulatory compliance requirements within pharmaceutical or biotech environment.
  • Excellent interpersonal skills, with ability to interact effectively and work efficiently with people at all levels in an organization.                                                                                           

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: 71-21BA

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.

We are seeking a highly motivated professional in Project and Alliance Management at Associate Director/Director level to be a key member of a fast-paced and dynamic organization.

 Primary Responsibilities:

Reports to the SVP of R&D Operations, the candidate will lead cross-functional core team for the development of multiple IND enabling and early clinical stage programs. Further, the candidate will be managing external collaboration on selected projects.

The candidate will need excellent cross-functional leadership abilities to work with management, project teams, and collaborators to conceive, design and implement product development strategy.

Specific responsibilities:

  • Providing strategic operational leadership, direction and support to cross-functional teams
  • Providing Project Management expertise to ensure all project milestones and deliverables are met, and that tasks are well executed and managed
  • Proactively identifying and critically analyzing problems affecting programs and developing viable solutions; ability to identify risk mitigation plans
  • Facilitating achievement of goals for program and supervising ongoing progress of key project results against Ambrx’s overall goals by identifying potential risks and contingency plans
  • Assessing the needs of the program and department and influencing strategic operational decisions to drive success
  • Acting as a key liaison between Ambrx and corporate partners/ or vendors preparing major presentations for joint collaborating meetings effecting important business decisions
  • Crafting and driving new processes and tools to ensure vertical and horizontal integration across functional areas

Qualifications:

Education/Experience:

  • PhD or MS in biological science with a Project Management Professional (PMP) certification
  • Minimum of 10 years’ experience in the pharmaceutical, life sciences or related industry
  • Minimum of 5 years in a drug development project/program leadership role
  • Experience with development of biologic drugs for oncology in biopharma/biotech is preferred
  • Fluent in speaking Mandarin Chinese is essential for alliance management

Professional and Personal Requirements:

  • Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy
  • Track record of leading development programs through preclinical and clinical phases of development
  • Thorough understanding of the drug development pipeline including: Research, Preclinical, Clinical, Manufacturing, Regulatory and Commercial
  • A proven record of implementing Project Management tools, methodologies, practices and infrastructure, as related to the Biopharmaceutical Industry
  • Outstanding influencing skills across the organization including executive/senior management
  • Strong written and verbal communication and be able to communicate effectively across functions and different levels of leadership
  • Expertise to work effectively in a fast-paced, team-based matrix environment as well as the ability to function independently

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 Code: 70-21BA

Ambrx (NYSE: AMAM) 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.

The Sr. Director FP&A reports directly to the Chief Financial Officer.  This position will be integral to the continued growth of the company, by providing financial support and analysis as well as strategic financial support throughout the company. Activities will include financial analysis and forecasting, budgeting, financial reporting, financial consulting and strategic support to senior management, including report preparation, financial presentations, capital expenditure analysis, new business opportunities analysis, and other projects as requested.

 Primary Responsibilities:

  • Responsible for budgeting, forecasting and reporting on a company-wide basis. Develop and maintain overall financial planning calendar and process for the current year budget, forecast updates and long-range financial plan.
  • Conduct quarterly and monthly financial reporting, including but not limited to monthly executive packages, board of director presentations, and budget summaries.
  • Prepare and distribute monthly/quarterly financial reports with operating results (consolidated and departmental level) and provide quantitative and qualitative analysis of key variance and trends.
  • Work closely with business leaders to provide financial support to drive and influence strategic decision-making within a broad scope (e.g., balancing risk, approving significant deals). Regularly meet with functional and departmental managers to review and discuss budget vs. actuals.
  • Ensure that the financial strategies and initiatives are integrated with corporate and business strategies.
  • Work closely with clinical and accounting team on developing clinical trial accrual worksheets.
  • Design business processes and draft appropriate policies and procedures to support those business processes.
  • Analyze current and past trends in key performance indicators including all areas of revenue, cost of sales, and indirect expenses.
  • Monitor performance indicators, highlighting trends and analyzing causes of unexpected variances
  • Manage the continued development of Budgeting, Financial Forecasting, Operating Plans, and Modeling tools including Ad-Hoc Reporting and Analysis.
  • Improve performance by evaluating processes to drive efficiencies.
  • Develop complex and dynamic financial models and analyses to support strategic initiatives.
  • Oversee the key controls within domains of responsibility to ensure compliance with legal and accounting requirements.
  • Manages company FP&A system and supports evaluation and implementation of new financials systems while working closely with internal and external stakeholders.
  • Assists in the preparation of materials for management and audit/board committee meetings.
  • Support various Investor relations related activities, including reviewing and summarizing analyst reports; assistance with quarterly and annual Earnings Release, Investor Decks and other outside communications as appropriate.

Job Qualifications:

  • 10+ years of progressive, relevant experience, with a mix of small and large, public company experience; previous experience in Biotech highly preferred.
  • Bachelor’s degree / advanced degree in accounting, finance or economics; CPA preferred.
  • Ability to pivot and work well in fast-paced environment, with significant growth.
  • Demonstrated experience creating concise decisions, with supporting analysis.
  • Excellent project management and prioritization skills.
  • Demonstrated ability to provide finance consultation to senior managers.
  • Advanced Microsoft Excel and PowerPoint skills.
  • Expertise in utilizing enterprise systems and reporting tools such as Adaptive Insights.
  • Experience in utilizing financial systems such as Great Plains, or similar systems.
  • Thorough understanding of accounting principles and financial analysis.
  • Demonstrated, strong leadership skills, with the ability to ability to roll-up sleeves and work with team members in a hands-on management capacity.
  • Excellent interpersonal and communication skills, with the ability to communicate developed strategies and analysis clearly and effectively.
  • Ability to think creatively, accompanied with strong analytical and organizational skills
  • Detail oriented with insight to determine applicability of big picture analysis.
  • Proactive problem solver, expected to present problems and recommendations simultaneously.
  • Strong leadership and influence skills with a demonstrated business partnering approach.

 

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: 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: 63-21BA

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.

The successful candidate will be a valuable member in the Analytical and Formulation Development group at Ambrx. As a vital member of this functional area, this individual should be able to maintain high standards of technical and quality excellence and may be tasked with providing day-to-day guidance for Associate Scientists and Research Associates in the lab.

 Responsibilities:

  • Develop analytical methods/assays ensuring that the projects are progressing as planned, process and products meet quality and regulatory requirements.
  • Oversee and perform assay development, qualification/validation and method transfer to CMO/CRO to support clinical manufacturing, release, and stability studies.
  • Work hands-on to develop and routinely test state-of-art analytical methods (HPLC assays, CE, icIEF, LC/MS, peptide mapping impurity characterization, glycan analysis, biophysical assays etc.); perform formulation development, compatibility, comparability, forced-degradation, and stability studies.
  • Oversee method performance, release and stability studies for Reference Standard, mAb, DS, DP at CMO.
  • Develop and apply new technologies for analysis of complex protein molecules (including E. coli and CHO derived proteins/antibodies) and conjugates for research, process development, and clinical development.
  • Write and diligently review analytical test methods, development reports, qualification protocols and reports.
  • Lead efforts in protein and protein conjugates testing and characterization. Provide subject matter expertise across functions in research, research transitioning to development and product development stages.
  • Participate in project teams to provide analytical support and coordinate resources for new and ongoing projects, from research to clinical stages.
  • Maintain current knowledge of latest scientific and technical trends in the field.

Requirements:

  • PhD. in Analytical Chemistry/Pharmaceutical Sciences or related field with at least 4 years of relevant industrial experience in analytical method development, formulation development and characterization of proteins. Exceptional non-PhDs with demonstrated capabilities and experience may also be considered.
  • Must have essential hands-on experience and in-depth knowledge in instrumentation and modern analytical chemistry techniques of proteins (SEC, IEX, RP-HPLC, HILIC, affinity, SPE etc; LC/MS, peptide mapping, CE, spectrometry, biophysical assays such as DSC, DLS, HIAC etc.) applied to biologics. Experience with rigorous in-depth MS characterization of mAbs/ADCs is a plus.
  • Significant experience with recombinant proteins, monoclonal antibodies, ADC, bi-specifics, and PEGylated proteins highly preferred.
  • Must be able to demonstrate technical proficiency, scientific creativity, independent thought, and motivation.
  • Proven record in developing and applying new technologies for analysis of complex protein molecules, attention to detail in experimental design and data quality as well as excellent troubleshooting skills are required.
  • Experience with assay development, qualification/validation and tech transfer to CMO/CDMOs to support clinical manufacturing.
  • Prior experience with GMP-compliance and Quality/Regulatory Assurance is desirable.

 

Excellent oral, presentation, and written communication skills, ability to communicate effectively with cross functional team members, management, corporate functions and CMO/CDMOs.

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: 64-21BA

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.

 

Ambrx is seeking an experienced and highly motivated Toxicologist to join the Preclinical Science group in our fast-paced and dynamic organization. The successful candidate will play a key role in setting safety pharmacology strategy, designing and executing tolerability and toxicokinetic (TK) studies, overseeing drug metabolism (DM) studies, and supporting pharmacokinetic (PK) studies and modeling as appropriate to help progress novel protein therapeutics from preclinical research into IND enabling studies.

 

Primary Responsibilities:

Responsible for all aspects of Toxicology and DMPK functions:

  • Design, outsource, and manage non-GLP and GLP toxicology and safety pharmacology studies in support of projects from discovery to early clinical development.
  • Prepare study protocols and reports related to toxicology studies.
  • Interpret study results from toxicology in conjunction with DMPK and pharmacology studies to estimate therapeutic index.
  • May perform/oversee/outsource pharmacology, DMPK studies, PK/PD modeling for dose predictions and/or candidate selection as appropriate.
  • Lead early hypothesis-driven investigations into mechanisms of toxicity for the proactive management of potential safety liabilities.
  • Communicate study status, timelines and data to key stakeholders.
  • Collaborate and interface with other functional areas including biological, bioanalytical and translational sciences, in vivo pharmacology, clinical and regulatory teams to facilitate development and execution of study plans.
  • Serve as Toxicology representative on multidisciplinary project teams.
  • Contribute to regulatory submissions.
  • Stay current with the latest toxicology trends and regulatory requirements.

 

Job Requirements:

  • Ph.D. in Toxicology, Pharmacology or related discipline with at least 5 years of drug discovery and development experience in the Pharma/Biotech industry.
  • Experience in designing and conducting non-GLP and GLP toxicology and pharmacokinetic studies with biologics for lead candidate selection and IND enabling studies is essential.
  • Experience in authoring toxicology reports and nonclinical summaries for regulatory submissions is required.
  • Experience selecting CROs and managing external contracts.
  • Ability to independently interpret results from toxicology studies to guide lead candidate design and selection is required.
  • Experience in estimation of human equivalent dose (HED) and maximum recommended starting dose (MRSD) based on results from non-clinical studies is a plus.
  • Ability to manage multiple projects simultaneously.
  • Certification by the American Board of Toxicology (DABT) is a plus.
  • Knowledge of GLP regulations and relevant FDA, EMA, and ICH guidance documents is highly desired.
  • Expertise in analysis of PK/PD data and PK modeling and simulation using Phoenix WinNonlin, and contributions to PK/TK reports is preferred.
  • Experience working with ADCs, T-Cell engagers for oncology indications is a plus.
  • Excellent time management, communication, organizational and collaborative skills.
  • Ability to be a self-starter as well as work in an interdisciplinary team.

 

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: 65-21BA; 66-21BA

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 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.

Job Description:

We are seeking a highly motivated and experienced Clinical Trial Manager (CTM) to join our fast paced and dedicated Clinical Operations team. This position is accountable for all activities related to the planning, timely execution, and efficient conduct of assigned clinical studies in support of Ambrx’s clinical development programs. The CTM will work independently and in a fast-paced team environment, manage both ongoing and new clinical trials, select vendors and oversee CRO activities, negotiate site budgets and contracts, draft study plans and manuals, review and track monitoring reports, review and approve clinical trial invoices, liaise with CMC, QA, and relevant stakeholders, ensure clinical conducts are in compliance with FDA regulations and ICH/GCP requirements while driving milestones according to established goals and timelines.

Job Requirements and Qualifications:

  • Bachelor’s degree in nursing or life sciences or equivalent
  • 8+ years experience managing all aspects of clinical trials
  • Excellent oral/written communication and organizational skills
  • Strong interpersonal skills and highly motivated
  • Ability to perform both independently and in a fast-paced and matrixed team environment
  • Demonstrated prior success in leading phase 1-3 US and international clinical studies including overseeing CRO(s) and site activities to ensure data integrity, PK samples and study drug reconciliation, and all clinical trials are conducted efficiently and in compliance with FDA regulations, ICH/GCP guidelines, and applicable country specific regulations and guidelines.
  • Provide inputs for protocol development and amendments; develop and implement ICFs, clinical study plans, manuals, and forms, such as Monitoring plan(s), Pharmacy Manual(s), CRF Completion Guidelines, Site Management Plans, Protocol Deviation Management Plan(s), Site Initiation Presentation, IRB/EC/REB regulatory packages etc.
  • Support preparation of regulatory submission documents Annual Reports, DSUR, IB, CSRs.
  • Manage central lab, PK samples and study drug reconciliation, address questions with sites, CRAs, and core lab(s), ensuring compliance with protocol and timely analysis and reporting of PK data.
  • Willing/able to travel 20% – 30%, valid, current passport

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.