Exec Director, Formulation & Process Development at Gilead Sciences

Foster City, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Ph.D. in pharmaceutical sciences or related field (inferred from incomplete "Ph.D. in pharm")

Responsibilities

Provide leadership and direction to the Formulation and Process Development organization, a department of >70 scientists for small molecule formulations including oral solid dosage forms and sterile injectables
Responsible for the design & development of products for all small molecule, peptides, and synthetic oligonucleotides NMEs from lead optimization to commercialization
Provide technical, operational, and strategic guidance on a wide range of activities across all development stages (lead optimization of pre-clinical drug candidates, preformulation, formulation development, process scale-up, technology transfer, process validation of clinical drug candidates, and commercial support)
Demonstrate a thorough understanding of the cGMP environment (internal and external cGMP manufacturing operations) and compliance requirements
Provide guidance and strategic directions through interactions with each formulation and process development (FPD) team
Ensure successful transfer of new products and technology to internal and external clinical and commercial manufacturing sites, including generation of knowledge and understanding to support product robustness targets
Serve as a senior member of the Technical Development Leadership Team responsible for developing and establishing small molecule strategy
Evaluate and implement new technologies to drive innovation in Formulation and Process Development for small molecules
Drive development and implementation of new systems to improve project execution and data management
Lead collaborations with Gilead PDM functions such as Quality Assurance, CMC Reg, Manufacturing and Technical Operations, Product and Portfolio Management, Finance and Supply Chain
Ensure strong relationships with key stakeholder functions including Research, Clinical Development, and Clinical Supply Management and Product Strategy Teams by providing technical and strategic input
Hire, mentor and develop team members within the organization
Support regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections
Provide technical support to internal and external cGMP manufacturing operations
Develop and manage department budget

Skills

Formulation Development

Process Development

Small Molecule Drug Product

Oral Solid Dosage Forms

Sterile Injectables

Drug Commercialization

Pharmaceutical Sciences

Proteins/Peptides

Gilead Sciences

Develops and commercializes biopharmaceuticals

About Gilead Sciences

Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.

Foster City, CaliforniaHeadquarters

1987Year Founded

$15,873.6MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Paid family time off and paid parental time off

Generous 401(k) contribution matching

Comprehensive medical plans that cover both physical and mental healthcare

Global Wellbeing Reimbursement

Time Off

Global Volunteer Day

Giving Together Program

Employee Support Programs

Flexible Work Options

Risks

Increased competition in HIV treatment from ViiV Healthcare's expanding drug portfolio.

Regulatory scrutiny over drug pricing could impact Gilead's U.S. market operations.

Patent expirations, like Truvada's, lead to increased generic competition and revenue loss.

Differentiation

Gilead's lenacapavir is recognized as the 2024 Breakthrough of the Year for HIV care.

Partnerships with LEO Pharma and Tubulis enhance Gilead's focus on inflammatory and cancer therapies.

Gilead's commitment to health equity initiatives like COMPASS and HepConnect sets it apart.

Upsides

Gilead's strategic partnerships expand its reach in inflammatory and oncology drug markets.

Investment in digital health technologies enhances Gilead's R&D and patient engagement.

Focus on sustainability improves Gilead's operational efficiency and corporate reputation.

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