Sr. Biologics Engineer II (Sr. Manager), MS&T – Downstream
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 II (Downstream) at our biologics facility in Morris Plains, New Jersey. We are seeking motivated, team-oriented individuals with expertise in downstream biopharmaceutical processing.
- Represent Manufacturing Sciences and Technology (MS&T) on project core teams and sub-teams as a Subject Matter Expert (SME) to coordinate multi-functional activities relating to clinical and commercial drug product manufacturing processes, tech transfer, validation, supply/supply chain, quality/ compliance, change management and product life cycle management.
- 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.
- Lead technology transfer activities ensuring gap analysis/risks assessments are performed and mitigation plans are in place through internal/on-site characterization and engineering runs, ensure design spaces (PAR &NOR ranges) are built for critical process parameters for validation and routine manufacturing operations, effective information flow, issue resolution, and documentation in accordance with the expectations of tech transfer quality system.
- Lead the process validation activities ensuring design of validation strategy is in alignment with business needs, regional & global regulatory compliance and support continued process verification post validation
- Review and approve technical documentation including protocols, master batch records, and reports related to engineering run, GMP run and PPQ runs.
- Ensure regulatory inspection readiness and product compliance with regional regulatory requirements.
- Partnering with product development, manufacturing, quality and regulatory, lead quality 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.
- Develop and implement control strategy, identify and implement operational improvements and identify novel technological approaches to and improve product quality attributes and enhance yield.
Knowledge, Experience & Skills:
- Experience in managing complex manufacturing execution systems including tech transfer, process characterization, process validation of biological products is highly desirable.
- Process development and operations experience/expertise in downstream biopharmaceutical manufacturing processes including chromatography, UFDF, Viral Filtration, Bulk Filling, etc.
- General understanding protein structure and its modes of degradation under various processing conditions.
- Preferred degree in Chemical Engineering, Bioengineering, Pharmaceutical Sciences or related field, and appropriate years of experience.
- 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.
- Master’s degree and 6+ years of relevant experience; or Bachelor’s degree and 8+ years of relevant experience.