Scientist, Process Development at Gilead Sciences

Edmonton, Alberta, Canada

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Knowledgeable and motivated professional capable of working effectively in a multi-disciplinary team environment
Experience with chemical process development and optimization, process characterization, risk assessments, scale-down and scale-up studies
Experience with process technology transfer and process validation activities, continued process verification, and manufacturing investigations
Experienced with manufacturing operations and supporting commercial manufacturing as a technical subject matter expert (SME) for one or multiple API projects
Understands quality and compliance principles associated with cGMP manufacturing
Able to support investigation of manufacturing deviations, out-of-specifications, and complaints
Ability to think critically and creatively, work independently, determine appropriate resources for resolution of problems, and have strong organizational and planning skills
Demonstrates ability in developing methods, techniques, and evaluation criteria for obtaining results and interpreting experimental outcomes
Excellent communication skills

Responsibilities

Develop chemical processes for the manufacturing of drug substances
Plan, design, implement, and analyze laboratory experimentation to advance the knowledge of production and quality attributes of drug substances
Advise members of project teams in the initiation and execution of laboratory experimentation, considering various factors
In collaboration with senior scientists or scientific directors, advance the development of economical, state-of-the-art techniques to isolate, characterize, purify, and mass-produce substances
Prepare and review technical documents including research reports and process development reports
Act as MSAT SME for one or multiple API projects and support commercial manufacturing
Monitor key manufacturing activities and manufacturing performance, provide regular updates, proactively communicate issues, and identify improvement opportunities
Prepare and review manufacturing and transfer documents including contract manuals, batch records, continued process verification, and validation protocols and reports
Support technical transfers and process validation activities at internal and external manufacturing facilities
Support investigation of manufacturing deviations, out-of-specifications, and complaints
May make contributions to scientific literature and conferences through publication and presentation of research results

Skills

chemical process development

process optimization

process characterization

risk assessments

scale-down studies

scale-up studies

process technology transfer

process validation

continued process verification

small-molecule manufacturing

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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