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Job Description

Sr. Manager, Commercial Biologics Analytical Operations

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.

Roles and Responsibilities:

The Commercial Biologics Analytics Operations (AO) organization at Gilead is responsible for the technical oversight and commercial analytical support across a global production network. This organization is accountable for all commercial analytical operations, including method transfers, method validations, method remediation’s, method investigation support, method life cycle management along with analytical support of drug substance and drug product manufacturing. This organization is also responsible for comparability, stability and specification setting strategies as well as network and importation testing strategies for all of Gilead’s marketed biologics products.

We are seeking a highly motivated individual with analytical development experience to support the Commercial Biologics AO organization. Primary responsibilities include ensuring timely completion of portfolio & functional deliverables and serving as a key link between commercial analytical function and other functional groups across the Biologics Operations organization at Gilead, to ensure seamless partnership and progress on organizational objectives. Experience with multiple modalities preferred, including hybrid molecules, ADCs, bispecifics.

Essential Duties and Job Functions:

• Support multiple, complex long- term portfolio deliverables for late phase and commercial programs, including method validations & transfers, in process controls, reference standard & specification strategies, comparability & stability strategies, importation testing & network testing strategies.  Support investigations change controls as needed. Ensure that all deliverables meet the highest scientific, regulatory, quality, and commercial standards.

• Support implementation of phase-appropriate strategies, business processes, systems, and practices for efficient achievement of analytical deliverables in accordance with cGMP and ICH guidelines and industry best practices. Support the commercial testing network ensuring effective information flow, timeline execution, issue resolution, and documentation in accordance with governing quality system requirements while leveraging robust risk management practices.

• Provide technical support for new product introductions, lifecycle management, investigations, troubleshooting and writing/review of technical reports.  Must stay current with relevant technologies and demonstrate forward thinking. Strong planning and resource management skills in a dynamic environment located across multiple geographies.

• Review and summarize analytical data (including stability data) from CTLs/CROs/CMOs, conduct trend analysis, provide feedback and recommendation in assisting the timely resolution of technical and/or quality issues.

• Maintain strong relationships with internal/external stakeholders. Collaborate with Quality Control, Drug Substance/Drug Product Technical Operations, Quality Assurance, External Manufacturing and CTLs, Regulatory CMC, Process Development, and other functional areas. Communicate across cross-functional / cross site teams to facilitate ensure timelines, deliverables, and business operations are aligned and met.

• Support Commercial Biologics AO during external and internal regulatory inspections/audits. Participate in writing, reviewing and approving CMC sections of US and international clinical trial applications, regulatory question responses, supplemental biologics license applications and international variations.

• Travel may be required in support of transfers/performance management of CTLs.

Specific Education & Experience:

• 0+ years of relevant experience and a PhD in a relevant scientific discipline OR

• 6+ years of relevant experience and an MS in a relevant scientific discipline OR

• 8+ years of relevant experience and a BS in a relevant scientific discipline

Skills:

• Strong understanding and extensive hands‐on experience in analytical development, method transfers and method validations. Deep understanding of product quality attributes control strategies as applied to biopharmaceutical processes. Expert understanding and hands-on experience of methods within the following platforms: chromatography, capillary techniques, ELISA techniques, and compendia assays supporting biologics manufacturing.

• Strong knowledge of cGMP requirements for clinical and commercial testing & manufacturing, and experience working with external manufacturing and testing organizations.

• In-depth knowledge of industry best practices & trends. Familiarity in forensic investigations in support of manufacturing of biologics. Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical operations. Proven experience in the generation of relevant regulatory sections of IND, BLA and MAA filings.

• Demonstrated success working with diverse team members in a dynamic, cross‐ functional environment. Proactively identifies issues and provides solutions through solid problem-solving skills.

• Motivated self-starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation and scientific writing skills. Strong self-awareness of the impact communication and working style has on others. Exceptional influencing, partnership, and collaboration skills and ability to drive results within a matrix environment.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead

About Gilead:

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.