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Genentech

Biotech firm creating medicines via R&D

Assistant Project Manager

Regulatory & Quality (Life Sciences)Posted on Nov 9
Full-timeSouth San Francisco, CA, USAIn-person

About the Job

Requirements

  • A Bachelor’s degree or higher is required.
  • 0–2 years of relevant work experience in process validation is required.
  • Experience with process validation documentation requirements is required.
  • Business acumen and sound judgment to work autonomously are required.
  • Communication and interpersonal skills to establish collaborative relationships, resolve conflicts positively, and influence without authority are required.
  • Project management skills to consistently complete multiple tasks on time are required.
  • The ability to adapt and handle multiple priorities, conflicts, and ambiguity is required.

Responsibilities

  • Coordinate assigned Process Validation study documents for projects and support Health Authority submissions.
  • Proofread, edit, and compile supporting data for Process Validation protocols and reports to ensure accuracy, completeness, and consistency.
  • Coordinate the adjudication of reviewers’ comments with authors and subject matter experts, and follow up promptly on outstanding queries.
  • Perform compliance reviews of completed Process Validation work to ensure alignment with internal Quality standards and requirements.
  • Facilitate Process Validation template creation and assist in training cross-functional teams on workflows, timelines, and compliance requirements.
  • Communicate with cross-functional project teams, present Process Validation activities at department meetings, and resolve conflicts positively.
  • Use appropriate information technology solutions and tools to manage process knowledge, and gather key technical information to keep systems updated.

Desired Qualifications

  • Hands-on experience authoring and/or editing process validation documentation.

About the Company

Genentech

Biotech firm creating medicines via R&D

Genentech develops medicines and therapies to address unmet medical needs through extensive biotechnology research and development. Its products include biologic and small-molecule treatments prescribed by healthcare providers and sold through partnerships with suppliers and health systems. It differentiates itself with a large R&D footprint, a vast patent portfolio, and FDA Breakthrough Therapy Designations that accelerate promising therapies. Its goal is to advance medical science and deliver high-quality, effective therapies that improve patient health while supporting the broader medical community.

Company size
10,001+
Company stage
IPO
Headquarters
San Francisco, CA
Founded
1976

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