Sr. Manager, Commercial Biologics Analytical Operations

Company: Gilead Sciences, Inc.
Location: Oceanside
Posted on: January 14, 2023

Job Description:

For Current Gilead Employees and Contractors:Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI-/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.Job DescriptionSr. Manager, Commercial Biologics Analytical OperationsGilead 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 Gileads 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:
  • 4+ 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 disciplineSkills:
    • Strong understanding and extensive handson 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/GileadAbout 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.For jobs in the United States:As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf)Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.For Current Gilead Employees and Contractors:Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI-/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to be fully vaccinated against COVID-19 as a condition of employment. T he health of our employees, contractors, their loved ones, our partners and the communities and people we serve is a top priority. Vaccination is the most effective way currently available to deliver on that priority.The purpose of the vaccination requirement is to minimize the spread of COVID-19 in the workplace and support the health and safety of our communities. A person is considered fully vaccinated two weeks after the second dose of a two-dose vaccine or two weeks after a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request an accommodation.

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