Principal Scientist, Biologics Pivotal Formulation & Process Development at Gilead Sciences

Foster City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

PhD / PharmD with 5+ years of relevant experience, or MA / MS degree with 8+ years of relevant experience, or BA / BS degree with 10+ years of relevant experience
Degree in Chemical Engineering, Bioengineering, Pharmaceutical Science, or related fields
Industry experience in biologics CMC development
Preferred Qualifications
End-to-end experience of biologics formulation and process development, including both early- and late-stage development experiences
Experience of IND and/or BLA filings
Expertise in lyophilization cycle development and GMP drug product fill and finish
Working knowledge of lab automation, data science, and knowledge management
Hands-on in lab execution and experience training junior members
Publication and external presentation track records demonstrating strong technical innovation capabilities and industrial influence
People management experience

Responsibilities

Lead key elements of complex programs, such as portfolio projects, department initiatives, scientific collaborations, new technology assessments, and workflow optimization to help the department reach its goals
Design and execute formulation and drug product process development work packages for biologics, to support pivotal formulation development, drug product manufacturing, and clinical in-use evaluations
Demonstrate deep understanding of analytical, biophysical characterization, or process development techniques; bring new capabilities; lead by example for lab executions
Fully embrace data integrity and good documentation practices for data and report generation; critically review internal and external documentations
Work with functional leaders to develop a functional handbook to pursue business process and technical excellence
Represent function and work collaboratively on cross-functional teams to support project team strategy and regulatory filings
Drive innovation and continuously grow technical expertise; influence internally and externally through publication, presentations, and industrial collaboration representation
May coach direct reports

Skills

Key technologies and capabilities for this role

Biologics FormulationProcess DevelopmentCMC DevelopmentPharmaceutical DevelopmentDrug Product LeadershipPortfolio ManagementScientific CollaborationTechnology Assessment

Questions & Answers

Common questions about this position

What is the employment type for this Principal Scientist role?

The position is full-time employment.

Is this Principal Scientist role remote or office-based?

This information is not specified in the job description.

What key skills are required for the Principal Scientist position?

The role requires deep understanding of analytical, biophysical characterization, or process development techniques for biologics, expertise in formulation and drug product process development, and strong skills in data integrity and documentation practices.

What is the company culture like at Gilead?

Gilead emphasizes collaboration, determination, and a relentless drive to make a difference, with a focus on evolving culture through great leaders who create inclusive, developing, and empowering environments for employees.

What makes a strong candidate for this Principal Scientist role?

A strong candidate brings relevant technical expertise in biologics formulation and process development, can lead complex programs and cross-functional teams, and demonstrates innovation through publications, presentations, and collaborations.

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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