Sr. Biologics Engineer I, Global Technical Operations (Drug Substance) (Open)
Sr. Biologics Engineer I, Global Technical Operations (Drug Substance)
Morris Plains, New Jersey
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.
This position is responsible for providing technical expertise and leadership to drive the seamless technology transfer and process validation activities for manufacturing Biologics and Anti-body Drug Conjugates (ADCs). The Sr Engineer will engage and work with both internal (drug substance/product/process development teams) and external partners (CMOs) to ensure all the drug substance processes are robust, scalable and well characterized before introducing into clinical or commercial manufacturing facilities. The individual will lead in the design and execution of validation strategies, qualifying manufacturing unit operations and sites to ensure supply plan meets the regional demand forecast and MOH targets. The individual will also serve as a key process owner in leading CMOs on establishing GMP processes, continuous process verifications, driving process improvements and providing technical leadership during quality investigations of complex deviations/non-conformances. The Sr Engineer is expected to work closely with regulatory in preparation/coauthoring regulatory filings (CTAs, BLAs, CBE and PAS) and addressing issues associated with CMC actionable complaints.
This position requires hands on individual with proven track record of achievement in managing complex manufacturing execution systems, excellent/effective communication and people skills.
Responsibilities:
- Lead and be hands-on with manufacturing process validations and transfers within internal and external CMOs for Biologics and Anti-body Drug Conjugates (ADCs).
- Represent Global Technical Operations on project core teams and sub-teams as a Subject Matter Expert (SME) to coordinate multi-functional activities relating to clinical and commercial drug substance 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, GMP 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.
- Cultivate excellent working relationship with stakeholders to deliver successful manufacturing campaigns.
- Apply manufacturing process lifecycle management principle for establishment and continuous improvement of process control strategy.
- Maintain strong knowledge of GMPs and manage external CMOs.
- Collaborate with process and pharmaceutical development to deliver manufacturing processes that meet the speed, yield and product quality requirements of the development programs.
- Perform critical data review and provide directions for troubleshooting and investigation.
- Demonstrate hands-on technical leadership in the laboratory, oversee and delegate experimental/project responsibilities as needed, and write/review development summary reports and author sections of regulatory submissions.
- Perform other duties as required.
Knowledge & 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 drug product manufacturing processes including bulk freeze/thaw, mixing/pooling, filtration, filling and lyophilization.
- General understanding protein structure and its 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.
Basic Qualifications:
7+ years of experience in the pharmaceutical industry and a BS or BA; or 5+ years of relevant experience and a MS.