Senior Biologics Engineer I (Drug Product)

Description de l'emploi

As a member of Global Biologics Manufacturing Sciences and Technology (MSAT), the Senior Biologics Engineer I (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 contribute to authoring of process transfer documents, risk/gap assessments, validation protocols/reports, and regulatory filings.

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

Job Responsibilities

• Represent Global Biologics MSAT group on project teams as a subject matter expert for sterile fill/finish activities including process transfer and validation.
• Contribute to project workstreams such as facility fit, risk assessments, control strategy development, validation strategy, change management. Author reports associated with these activities.
• Follow 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.
• 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.
• Review technical documentation including protocols, master batch records, and reports for engineering runs, GMP and PPQ campaigns.
• Contribute to process validation sections of regulatory filings in support of commercial launch/expansion.
• 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

Qualifications

• Degree in Chemical Engineering, Bioengineering, pharmaceutical sciences or related field, and appropriate years of experience: Ph.D. with 0+ years work experience OR MS with 4+ years of relevant work experience, OR BS with 6+ years of relevant work experience
• 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 highly desirable.
• Working knowledge of GMPs and regulatory requirements of biopharmaceutical manufacturing
• Excellent troubleshooting skills and ability to solve complex technical issues.
• General understanding of protein structure and modes of degradation under various processing conditions
• 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