Exec Director, MSAT at Gilead Sciences

La Verne, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Experience leading tech transfer, validation, and technical services in a GMP-regulated environment (e.g., pharmaceuticals, biotech)
Proven track record in staff development, budgeting, cost control, and strategic planning
Ability to interface with senior leadership, regulatory agencies, and cross-functional teams
Expertise in investigations, CAPA, deviations, OOS, and regulatory compliance
Knowledge of process development, CPV, optimization, scalability, safety, and cost of goods
Leadership in commercial manufacturing projects and new product introductions
Familiarity with Gilead Quality Systems, SOP standardization, and harmonization

Responsibilities

Provide leadership on best practices for tech transfer and validation
Interface with Senior Leadership Team to set unified departmental goals and objectives
Assist with onboarding new technologies and oversee qualification programs
Ensure staff growth and development to meet business needs
Lead/coordinate investigations and CAPA recommendations for tech services and validation
Interface with regulatory agencies, representing Gilead in GMP matters
Lead standardization and harmonization of SOPs using Gilead Quality Systems
Coordinate and synchronize tech transfer and validation groups for new product introductions/projects
Lead strategic and tactical operations of the Technical Services team, including staff development, budgeting, cost control, and planning
Provide direction on resolving complex technical issues related to drug forms
Develop action plans for long-term systems implementation
Act as escalation point for complex/high-impact technical services issues
Lead cross-functional PDM teams for program planning and execution
Lead commercial projects, accountable for process performance, CPV, optimization, and investigations
Direct process development considering efficiency, scalability, safety, regulatory factors, and cost
Advise senior management on process development and R&D direction
Determine organizational objectives and interpret company policies
Review and approve capital expenditures
Ensure operations comply with SOPs, regulatory, and GMP standards
Liaise with manufacturing and development teams on technical transfers across sites
Serve as liaison with governmental agencies
Assist in company investigations (deviations, complaints, OOS, MRB)

Skills

Tech Transfer

Validation

CAPA

GMP

Regulatory Compliance

SOP Standardization

Quality Systems

Investigations

Staff Development

Technology Qualification

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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