Senior Biologics Engineer I (Drug Substance)

Описание вакансии

As a member of Global Biologics Manufacturing Sciences and Technology (MSAT), the Senior Biologics Engineer I (Drug Substance) role is focused on technology transfer and support of commercial antibody and bioconjugate processes. We are seeking motivated, team-oriented individuals with expertise in biopharmaceutical drug substance processing. The individual will serve as a key subject matter expert (conjugation/purification) for manufacturing and technology transfer activities including facility fit analysis, process validation, and post-approval changes. They will serve as a 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.

Job Responsibilities

• Represent Global Biologics MSAT on project teams as a subject matter expert for conjugation and purification manufacturing processes.
• Contribute to project workstreams such as facility fit, risk assessments, control strategy development, validation strategy, change management. Author reports associated with these activities.
• Collaborate with process development group to support process characterization activities 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.
• Execute change management procedures to ensure timely and successful implementation of new processes and subsequent changes. Partner with manufacturing, quality, and regulatory affairs during investigations to address OOS, OOT, and complex deviations.
• 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 drug substance downstream manufacturing processes i.e., conjugation, purification operations, bulk freeze/thaw.
• Experience supporting drug substance manufacturing operations, technology transfer, and/or development. Past history with commercial manufacturing and/or process validation is highly desirable.
• Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing
• General 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