Scientist 2, Technical Development & Services

Company: Initial Therapeutics, Inc.
Location: Novato
Posted on: March 22, 2025

Job Description:

About Technical OperationsBioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.TITLE AS Analytical Product Lead (Commercial) Scientist 2 SUMMARY The AS APL Scientist 2 will collaborate with internal and external stakeholders to support BioMarin's clinical development and commercial manufacturing testing activities. Key activities including leading the development of control system strategies for new and existing products; supporting in-country test laboratories, leading the method lifecycle management, and authoring regulatory submission documentation. The APL Scientist will provide oversight, understanding and management of product attributes and analytical control strategy. Ensuring all aspects of analytical methods as part of analytical control strategy are suitable for their intended use and meet the Analytical and Quality Target Product Profile (ATTP/QTPP). Analytical Sciences contacts facing CMC, Quality Partner teams and other stakeholders.RESPONSIBILITIESAnalytical Lifecycle Management

• Accountable for phase appropriate method qualification, method optimization, method transfer and method validation strategies through all phases (including raw material methods not currently established at QC)
• Accountable for test method selection (strategy) and CTO selection
• Responsible for method life cycle management support
• Accountable for locating AS resources for testing support for process development, in-use studies, formulation development studies, scale-up/yield studies, external lab testing, characterization and forced degradation.
• Provide technical guidance, as subject matter experts to AS Laboratory Operations or QC Laboratories on the execution of method validation/transfer, DOE, Proof of concept study design, method lifecycle management, process comparability studies, forced degradation studies, process characterization, etc.; Design studies from other technical operations teams requiring CQA assessments, as applicable
• Develop technical strategies to aid method lifecycle management activities
• Lead the development of plans to investigate and troubleshoot/optimize/replace underperforming methods, as required
• Research new technologies for alternative testing or replacement of existing, aging or obsolete technology. Design proof of concept studies and work with executing analysts to manage these Proof-of-concept type studies, review output and draw conclusions to the proof-of-concept data and establish next steps
• Conduct strategic assessments for any new product method transfers and validations (for internal, external and in country test labs) and monitor the method development; draft master protocols and master reports for methods
• Conduct strategic assessments for any new technologies, method optimization or single method introductions for existing products; review progress and review / approve any change requests, new protocols, and reportsProduct Understanding and Control Strategy
  • Accountable and responsible for CQA assessment through all phases
  • Accountable (prior to PPQ) and responsible (after PPQ) for analytical control strategy
  • Accountable (prior to PPQ) and responsible (after PPQ) for sampling & testing plans aligned with analytical control strategy
  • Accountable for product characterization strategy
  • Responsible for product comparability, specification and stability strategy
  • Lead the development and implementation of phase-appropriate analytical control strategies, including test methods and specifications, in accordance with Critical Quality Attributes (CQAs). Ensure compliance with Health Authority (HA) and pharmacopeia requirements
  • Review methods and specifications, review of CQA reports from Process Sciences/MSAT for clinical products to assess the use of methodologies and specifications to ensure continuity and phase appropriateness
  • Oversee the control system strategy to ensure the implementation of market appropriate methods and specifications/controls; ensure that the method lifecycle control strategy considers 'future proofing' the methods and validations to ensure compliance with all market requirements (Japan, Brazil, etc.)
  • Collaborate with key stakeholders in the review of proposed stability plans, data sets, etc. for filings to ensure consistency and; identify trends that drive method requirements and ensure methods are fit for purpose
  • Ensure reporting / filing is updated and accurate for any revisions to analytical methods made during the review interval requiring regulatory impact assessments
  • Complete the documentation of the summary of reportable changes to analytical methodsRegulatory
    • Provide oversight on compliance of methods and specifications to Health Authority Industry and Pharmacopeia guidelines and requirements. Identify gaps and impacts when guidelines or pharmacopeia sections are updated
    • Author documentation summarizing reportable changes to analytical methods
    • Support the authoring and review of the CTD Module 3 DS and DP sections for INDs, IMPDs, BLAs, MAAs etc.
    • Author RTQs for methods and specifications and any other relevant sections; review responses from teams across QAT (standards/critical reagents, stability, and data) to ensure consistency, continuity
    • Respond to queries related to analytical control system and method establishment during internal and external audits; direct interaction with regulatory agency inspectors during audit may be requiredQMS
      • Responsible for technical assessments of QMS records as required (Deviation, CAPA, Change Controls) for technical assessment of analytical method or specification impacting recordsCross-Functional Leadership
        • Act as the primary AS single point of contact for assigned product programs; represent AS and the related control system strategy on the Quality Product Team
        • Support APR and AR activitiesEXPERIENCERequired Skills:
          • Bachelor of Sciences degree in a technical discipline (physical, engineering, IT, chemical or biological sciences) is required, an MSc, or higher, in a relevant degree is preferred.
          • Minimum 10 years+ of relevant GMP laboratory experience, with hands on experience of analytical techniques.
          • Ability to understand the big picture and focus on execution details
          • Familiarity with the required deliverables for analytical method lifecycle activities, such as method validation, transfers, etc.
          • Proven track record in a fast-paced, challenging, and complex matrixed team environment
          • High degree of demonstrated learning agility
          • Action-oriented with strong follow through
          • Strong interpersonal skills; fluent and able to influence others in spoken and written English
          • Strong computer skills, MS Office, MS Word, MS PowerPoint, MS-Project is preferred
          • Highly developed interpersonal skills with the proven ability to function effectively and tactfully with multiple departments and personnel, able to gain consensus and commitmentDesired Skills:
            • Experience with CMC activities for development programs (Clinical stage)
            • Experience in early-stage clinical programs
            • Lean-DMAIC expertise, Green belt or higher certification.
            • Strong regulatory and GMP acumen.EDUCATION
              • Bachelor of Sciences degree in a technical discipline (physical, engineering, IT, chemical or biological sciences) is required, an MSc, or higher, in a relevant degree is preferred. Qualification in Molecular Biology or Biochemistry is preferred.EQUIPMENT Standard office equipment CONTACTS ASPL leadership team, AS and TDS Leadership Teams, PQL Team, Regulatory affairs SUPERVISOR RESPONSIBILITY N/A SHIFT DETAILS Days Monday to Friday ONSITE, REMOTE, OR FLEXIBLE Flexible (minimum 2 days per week on site) TRAVEL REQUIRED Some travel may be required, less than once per quarterNote: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.Equal Opportunity Employer/Veterans/DisabledAn Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
                #J-18808-Ljbffr

Keywords: Initial Therapeutics, Inc., Novato , Scientist 2, Technical Development & Services, IT / Software / Systems , Novato, California