Talent.com
Director, Biologics Analytical Development (Pivotal and Commercial)

Director, Biologics Analytical Development (Pivotal and Commercial)

GileadSan Mateo, CA, US
30+ days ago
Job type
  • Full-time
Job description

Job Opportunity At Gilead

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

We are seeking a talented and highly motivated Director for our Structural Characterization team in Biologics Pivotal and Commercial Analytical Development. Broad experience in analytical development from early development to commercial launch, filing experience with FDA / EMA, and in-depth technology understanding for biological products are the key in this role, which will expand our rapidly growing Foster City team. A solid understanding of GMPs and CMC requirements is expected. Mass spectrometry experience is a must.

Responsibilities :

  • Provide leadership to a group of structural characterization scientists, including :

Mentor and guide scientists in their roles.

  • Set clear expectations and prioritization of work packages.
  • Recruit and hire new talent.
  • Accountable for :
  • Defining critical quality attributes (CQAs) across the late-phase biologics portfolio and building deep understanding of how CQAs relate to the product's function.

  • Driving continuous improvement of CQA identification strategies.
  • Leading innovation in mass spectrometry initiatives to build a best-in-class structure characterization function.
  • Leading higher order structure deliverables across the late-phase portfolio.
  • Support the design / justification / execution of end-to-end control strategy development through a proactive definition of the product quality targets.
  • Delivering high quality structural characterization work packages for supporting Pivotal IND and marketing applications.
  • Serve as an analytical project lead (ASTL) for late-phase program overseeing all analytical deliverables.
  • Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies.
  • Collaborate across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ensure timely delivery and successful commercialization of the late-stage Biologics portfolio.
  • Act as a key member of the extended Analytical Development leadership team to shape late-stage development strategies.
  • Demonstrate comprehensive knowledge in key analytical CMC strategic areas including CQAs, separations methods, method bridging, reference standard, comparability, and specifications.
  • Drive for the adoption of novel and state-of-the-art structural characterization technologies and approaches. Recruit, hire, and mentor talent to help cultivate a world class Biologics AD organization.
  • Basic Qualifications

  • Ph.D. with 8+ years in Mass Spectrometry or related fields of industrial experience in biologics analytical development and / or structural characterization with people leader accountabilities.
  • or
  • M.S. with 10+ years in Mass Spectrometry or related fields of industrial experience in biologics analytical development and / or structural characterization with people leader accountabilities.
  • Preferred Qualifications

  • Significant expertise in mass spectrometry and higher order structure techniques commonly used for biologics structural characterization.
  • Must have People Leader experience.
  • Experience with technologies may include but not limited to Mass spectrometry, Analytical ultracentrifugation (AUC), Size exclusion chromatography (SEC), Reversed phase chromatography, Ion exchange chromatography (IEX), Capillary gel electrophoresis (CGE), Light scattering techniques (DLS, MALS) and Molecular analysis.
  • Subject matter expert in establishing comprehensive control strategies for biologics products.
  • Well versed in FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product.
  • Proven track record in drafting regulatory documentation at all stages, including IND, BLA, and PAS filings.
  • Demonstrated ability of building strong collaborations with other CMC functions.
  • Strong business acumen, with ability to balance resource, budget, and program milestones.
  • Working knowledge of lab automation, computer validation, data governance, data science, knowledge management and data protection.
  • Leadership qualities of the successful candidate include the following : collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, strategic vision, executive presence. Ability to build high performing teams and to set clear and measurable goals for staff and prioritize projects and resources.
  • People Leader Accountabilities

  • Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
  • Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
  • Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
  • The salary range for this position is : $226,185.00 - $292,710.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

    Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 ApplicantAccommodations@gilead.com for assistance.

    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 apply via the Internal Career Opportunities portal in Workday.

    Create a job alert for this search

    Director Development • San Mateo, CA, US

    Related jobs
    • Promoted
    Director, Drug Product Development & Manufacturing

    Director, Drug Product Development & Manufacturing

    Remegen Biosciences, Inc.South San Francisco, CA, US
    Full-time
    Director, Drug Product Development & Manufacturing.Drug Manufacturing & Supply Management.VP, Drug Manufacturing & Supply Management. South San Francisco, CA or Remote.RemeGen Bioscience...Show moreLast updated: 30+ days ago
    • Promoted
    Senior / Executive Director, Discovery Biology

    Senior / Executive Director, Discovery Biology

    Firefly BioSouth San Francisco, CA, US
    Full-time
    Who We Are At Firefly Bio, our mission is to redefine cancer treatment.We are developing a new class of therapeutics called Degrader Antibody Conjugates (DACs), which combine the precision of antib...Show moreLast updated: 1 day ago
    • Promoted
    Director, Biologics Analytical Development (CMC Biologics)

    Director, Biologics Analytical Development (CMC Biologics)

    ExelixisAlameda, CA, US
    Full-time
    Director, Analytical Development.The Director, Analytical Development manages the analytical activities across multiple CMC biologics areas to support the development and manufacturing of biologica...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Director, Therapeutic Area Analytics & Insights - Cardiovascular, Renal, and Metabolism (CVRM)

    Senior Director, Therapeutic Area Analytics & Insights - Cardiovascular, Renal, and Metabolism (CVRM)

    GenentechSouth San Francisco, CA, US
    Full-time
    Senior Director, Therapeutic Area Analytics & Insights - Cardiovascular, Renal, and Metabolism (CVRM).We're passionate about delivering on Our Promise to improve the lives of patients and create he...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Director, Analytical Development and Quality Control

    Senior Director, Analytical Development and Quality Control

    Altos LabsSan Francisco, CA, US
    Full-time
    Senior Director, Analytical Development And Quality Control.Our mission is to restore cell health and resilience through cell rejuvenation to reverse disease, injury, and the disabilities that can ...Show moreLast updated: 27 days ago
    • Promoted
    Associate Director / Director, Computational Chemistry

    Associate Director / Director, Computational Chemistry

    Aerial TalentSouth San Francisco, CA, US
    Full-time
    Computational Chemistry Director or Associate Director with experience in CADD- and structure-based design for lead optimization of small molecules to advance the pipeline of innovative therapeutic...Show moreLast updated: 1 day ago
    • Promoted
    Director, Biologics Product Development

    Director, Biologics Product Development

    RAPT THERAPEUTICSSouth San Francisco, CA, US
    Full-time
    The Director of Biologics Product Development reports to the SVP, Technical Operations and is responsible for development of biologics drug product presentations and processes, oversee technology t...Show moreLast updated: 24 days ago
    • Promoted
    Senior Director, Analytical Sciences, Drug Product

    Senior Director, Analytical Sciences, Drug Product

    ORIC PharmaceuticalsSouth San Francisco, CA, US
    Full-time
    ORIC is a research-driven company dedicated to discovering and developing novel therapies that can Overcome Resistance In Cancer. Our collaborative, empowering culture gives scientists the authority...Show moreLast updated: 23 days ago
    • Promoted
    Executive Director, Analytical Development and Drug Product

    Executive Director, Analytical Development and Drug Product

    Marea TherapeuticsSouth San Francisco, CA, US
    Full-time
    Marea Therapeutics is a clinical-stage biotechnology company based in San Francisco with a growing pipeline of first-in-class therapies to address genetically validated cardioendocrine disease targ...Show moreLast updated: 12 days ago
    • Promoted
    Director - Life Sciences Advisory - Commercial

    Director - Life Sciences Advisory - Commercial

    GuidehouseSan Francisco, CA, US
    Full-time
    Consulting Manager, Life Sciences.Is life sciences in your DNA? Breakthroughs in pharma are helping people live healthier lives, while medical devices enable patients to proactively maintain health...Show moreLast updated: 30+ days ago
    • Promoted
    Director, R&D

    Director, R&D

    Thermo FisherPleasanton, CA, US
    Full-time
    We are excited to offer an outstanding opportunity to join our outstanding team at Thermo Fisher Scientific as a Director, R&D in Pleasanton, CA. The Pharma Analytics business unit focuses on develo...Show moreLast updated: 30+ days ago
    • Promoted
    Business Development Director - Bay Area

    Business Development Director - Bay Area

    Porton Pharma Solutions Ltd.San Jose, CA, US
    Full-time
    The position level varies from Associate Director to Director, determined by the candidate's background and qualification. West Coast - Preferred locations : Bay Area.Experience in business devel...Show moreLast updated: 1 day ago
    • Promoted
    Senior Director, Therapeutic Area Analytics & Insights - Rare Diseases

    Senior Director, Therapeutic Area Analytics & Insights - Rare Diseases

    GenentechSouth San Francisco, CA, US
    Full-time
    Senior Director, Therapeutic Area Analytics & Insights - Rare Diseases (RD).We're passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for al...Show moreLast updated: 30+ days ago
    • Promoted
    Director of Analytical Development

    Director of Analytical Development

    AntheiaMenlo Park, CA, US
    Full-time +1
    Director of Analytical Development.Antheia is a science and technology company developing next generation plant-inspired medicines. Applying synthetic biology, genomics, bioinformatics, data science...Show moreLast updated: 11 days ago
    • Promoted
    Associate Director, CMC Regulatory Affairs – Biologics

    Associate Director, CMC Regulatory Affairs – Biologics

    Gilead Sciences, Inc.Foster City, CA, United States
    Full-time +1
    Associate Director, CMC Regulatory Affairs – Biologics.We focus on HIV / AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.We seek to improve patien...Show moreLast updated: 19 days ago
    • Promoted
    Senior Director, Formulation and Drug Product Development

    Senior Director, Formulation and Drug Product Development

    Marea TherapeuticsSouth San Francisco, CA, US
    Full-time
    Marea Therapeutics is a clinical-stage biotechnology company based in San Francisco with a growing pipeline of first-in-class therapies to address genetically validated cardioendocrine disease targ...Show moreLast updated: 12 days ago
    • Promoted
    • New!
    Director, Biostatistics

    Director, Biostatistics

    Penfield Search Partners LtdHayward, CA, US
    Full-time
    Our client is a biopharmaceutical company committed to researching, developing, and commercializing transformative therapeutics to treat a broad spectrum of retinal diseases.Focusing on bringing ne...Show moreLast updated: 11 hours ago
    • Promoted
    Senior / Executive Director, Translational Biology

    Senior / Executive Director, Translational Biology

    Firefly BioSouth San Francisco, CA, US
    Full-time
    Who We Are At Firefly Bio, our mission is to redefine cancer treatment.We are developing a new class of therapeutics called Degrader Antibody Conjugates (DACs), which combine the precision of antib...Show moreLast updated: 1 day ago