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SR. ASSOCIATE, QC ANALYTICAL TECH

  • Location: Novato
  • $ Salary: Negotiable per year
  • Job Type:Permanent

Posted 12 months ago

  • Sector: Life Sciences
  • Contact: Summer Martinez
  • Expiry Date: 28 April 2023
  • Job Ref: JN -032023-478256

Senior Associate QC Analytical Technology

Novato, CA

The QC Analytical Technology (QCAT) Senior Associate will collaborate with internal and external stakeholders to support clinical development and commercial manufacturing testing activities. Key activities include supporting the development of control system strategies for new and existing products; supporting in-country test laboratories, supporting the method lifecycle management, oversight of compliance of methods and specifications to Health Authority, Industry and Pharmacopeia guidelines and requirements, providing analytical technical support to QCAT operations and site QC operations teams when required, preparing validation and transfer master plans for analytical methods, authoring regulatory submission documents and regulatory responses.

Ownership and management of project plans for QCAT activities, being a key subject matter expert for regulatory inspections. Training and educational development of other staff members are also expected.

This position reports to the QCAT Analytical CMC Lead.

EDUCATION AND EXPERIENCE REQUIRED

  • 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 5 years of relevant GMP laboratory experience.

KEY RESPONSIBILITIES

  • Actively participate in the development and implementation of phase-appropriate analytical control strategy, including test methods and specifications, in accordance with Critical Quality Attributes (CQAs). ensuring compliance with Health Authority (HA) and pharmacopeia requirements.
  • 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 method transfer studies for In-Country (IC) testing laboratories and act as the point of contact for the IC laboratories through the entire licensing period.
  • Provide technical guidance, as subject matter experts to QCAT Technical 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.; Assist in the design of studies from other technical operations teams requiring CQA assessments, as applicable.
  • 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 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 reports.
  • Support the authoring and review of the CTC Module 3 Drug Substance (DS) and Drug Product (DP) sections for INDs, IMPDs, BLAs, MAAs etc.
  • sections:sponse to Questions (RTQs) for methods and specifications and any other relevant sections; Review responses from teams across QCAT (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 required.

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

In the U.S., the salary range for this position is $ 91,200 to $ 136,800 per year, which factors in various geographic regions. The base pays actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.

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