Sr. Biologics Engineer II (Global MSAT)

职位描述

As a member of Global Biologics Manufacturing Sciences and Technology (MSAT), the Senior Biologics Engineer II (Drug Product) role is responsible for providing technical expertise to drive technology transfer and production activities for late-stage clinical & commercial biologic drug product manufacturing processes. Project scope may include introduction of new products to existing internal/external filling lines, transfer to new contract manufacturing partners, and manufacturing support of existing products. The incumbent will engage and collaborate with internal and external partners to ensure drug product process transfers are executed to ensure technical and regulatory success. They will support the design and execution of validation studies during process performance qualification (PPQ) and author process transfer documents, risk/gap assessments, validation protocols/reports, and regulatory filings.

The individual will serve as a key subject matter expert in support of GMP change management, manufacturing investigations, and interactions with health authorities. They will also serve as a key functional representative working with internal and external manufacturing sites to establish commercial manufacturing processes for Gilead products, implement continued process verification, and provide ongoing support to ensure uninterrupted market supply.

Foster City, CA

Job Responsibilities

• Represent Global Biologics MSAT group on project core teams and sub-teams as a subject matter expert and/or functional lead for drug product manufacturing activities including process transfer and validation.

• Lead and contribute to project workstreams such as facility fit, risk assessments, control strategy development, validation strategy, change management. Direct other team members in their execution of these activities. Author and review associated reports.

• Collaborate with process development group to support process characterization activities and establishment of design space to enable commercial tech transfer and validation. Participate in internal development teams as MSAT representative.

• Maintain accountability for GMP change management procedures to ensure timely and successful implementation of new processes and subsequent changes. Partner with process development, quality, and regulatory affairs during investigations to address OOS, OOT, and complex deviations.

• Review technical documentation including protocols, master batch records, and reports for engineering runs, GMP and PPQ campaigns.

• Author process validation sections of regulatory filings in support of commercial launch/expansion. Work with third party sites to ensure regulatory inspection readiness.

• Participate in cross functional business and scientific initiatives as MSAT representative, and effectively collaborate and influence cross-functional partners to support team objectives.

• Up to 20% travel in support of the above activities

Basic Qualifications

Degree in Chemical Engineering, Bioengineering, pharmaceutical sciences or related field, and appropriate years of experience:

• Ph.D. with 2+ years of relevant work experience

OR

• MS with 6+ years of relevant work experience

OR

• BS with 8+ years of relevant work experience

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Preferred Qualifications

• Strong understanding of biologics/sterile injectable product manufacturing processes e.g., bulk freeze/thaw, mixing/pooling, filtration, filling and/or lyophilization

• Experience supporting drug product manufacturing operations, technology transfer, and/or development. Past history with commercial manufacturing and/or process validation is expected.

• Strong grasp of GMPs and regulatory requirements of biopharmaceutical manufacturing

• Deep understanding of protein structure and modes of degradation under various processing conditions

• Excellent troubleshooting skills and ability to solve complex technical issues.

• Ability to effectively collaborate in a dynamic, cross-functional matrix environment.

• Excellent and effective verbal and written communication skills

• Experience working in agile global and multi-cultural teams