Sr. Biologics Engineer I, MS&T (CPV)

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

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Job Description
Sr. Biologics Engineer I - Continued Process Verification (CPV)

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Gilead has an opportunity for an experienced Senior Biologics Engineer I (CPV) at our biologics facility in Morris Plains, New Jersey. We are seeking motivated, team-oriented individuals with expertise in biopharmaceutical data analytics.

Job Responsibilities:

• Represent Manufacturing Sciences and Technology (MS&T) as a Continued Process Verification (CPV) Subject Matter Expert (SME) to coordinate multi-functional activities relating to CPV data collection, document generation and CPV investigations.
• Participate in cross functional business and scientific initiatives as the MS&T representative, and effectively collaborate and influence cross-functional partners to support MS&T objectives.
• Support the CPV activities ensuring strategy design is in alignment with business needs, regional & global regulatory compliance.
• Review and approve technical documentation including protocols, technical investigations and reports related to CPV.
• Ensure regulatory inspection readiness and product compliance with regional regulatory requirements.
• Partnering with cross functional Departments, support investigations and data analysis as SME to address OOS, OOT, complex deviations/non-conformances and implement change controls to ensure timely/prompt release of batches to meet regional demand forecast and ensure CAPAs are in place.
• Ensure high quality regulatory dossiers which set the benchmark in the industry and result in high regulatory acceptance.
• You support improvement of data collection and management to enable quick and reliable data analysis.

Knowledge & Skills:

• Experience with statistical data analysis tools.
• Strong project management and organizational skills
• Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing is preferred.
• Excellent troubleshooting skills and ability to solve complex technical issues.
• Understanding of guidelines required by FDA, EMA, and other regulatory bodies.
• Strong interpersonal and communication skills, verbal and written.
• Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
• Experience of working in global and agile cultural teams.
• High degree of technical competence and effective communication skills, both oral and written.
• Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others.
• Able to build strong relationship with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo.

Specific Education & Experience Requirements:

• Preferred degree in Chemical Engineering, Bioengineering, Pharmaceutical Sciences or related field, and appropriate years of experience.
• MS/BS and 5+ years of relevant work experience.
• Extensive experience in biotech or pharmaceuticals industry and drug conjugation experience highly desirable.

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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Full time