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At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

• Represent Commercial Biologics Technical Operations on project teams in support of technology transfer and validation of biologics drug substance 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.
• Follow GMP quality change management procedures to ensure timely and successful technology transfer activities. 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 support commercial tech transfer and validation. Participate in internal development teams as Commercial Technical Operations 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. Work with third party sites to ensure regulatory inspection readiness.
• Participate in cross functional business and scientific initiatives as CBTO representative, and effectively collaborate and influence cross-functional partners to support team objectives.
• Up to 20% travel in support of the above activities

• Degree in Chemical Engineering, Bioengineering, pharmaceutical sciences or related field, and appropriate years of experience: Ph.D. with no 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 manufacturing processes e.g., mammalian cell culture in bioreactors, harvest/recovery, downstream purification operations
• 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 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 of working in global and agile cultural teams

The salary range for this position is: $117,725.00 - $152,350.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.