Sr. Packaging Engineer II - Cold Chain at Gilead Sciences

Foster City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Deep technical expertise in biologics cold chain packaging, including thermal performance, material compatibility, and risk mitigation strategies
Experience with temperature-controlled shipping container qualification and the corresponding product quality testing
Strong understanding of FDA, EMA, and ICH guidelines and cGMP standards related to biologics and pharmaceutical packaging
Proven ability to collaborate with and influence external partners to deliver compliant and scalable solutions
Minimum 8 years of related experience with a Bachelor of Science Degree in packaging, mechanical, industrial, or biomedical engineering
Minimum 6 years of related experience with a Masters of Science Degree in packaging, mechanical, industrial, or biomedical engineering

Responsibilities

Lead the design and qualification of thermal protection systems, collaborating with internal stakeholders (e.g., Quality, Regulatory, Supply Chain, Analytical Ops.) and external partners to ensure robust, compliant solutions
Execute simulated and real-time shipping qualifications and thermal mapping studies, ensuring compliance with global regulatory expectations
Author technical documentation (protocols, reports, specifications, regulatory submission content) for temperature-controlled packaging systems
Serve as a subject matter expert (SME) for cold chain packaging, and guide cross-functional teams on best practices
Drive resolution of packaging-related deviations and investigations, particularly those involving temperature excursions or container failures
Monitor industry trends and regulatory changes related to cold chain packaging, including sustainability innovations, digital temperature monitoring, and evolving standards (e.g., USP, ISO, ISTA)
Evaluate internal procedures and update as necessary for continuous improvement, efficiency, and compliance

Skills

Key technologies and capabilities for this role

Packaging EngineeringCold ChainThermal Protection SystemsShipping QualificationThermal MappingPackage DevelopmentQualificationLifecycle ManagementRegulatory ComplianceSupply Chain

Questions & Answers

Common questions about this position

Is this position remote or on-site?

This is an on-site position located in Foster City, California.

What is the salary range for this role?

This information is not specified in the job description.

What key skills are required for the Senior Packaging Engineer II role?

The role requires deep technical expertise in biologics cold chain packaging, including thermal performance, material compatibility, and risk mitigation strategies, along with experience in temperature-controlled shipping container qualification.

What is the company culture like at Gilead?

Gilead emphasizes collaboration, determination, and a relentless drive to make a difference, with a focus on creating an inclusive environment where employees feel developed and empowered, supported by great leaders.

What makes a strong candidate for this packaging engineer position?

Strong candidates will have deep expertise in biologics cold chain packaging, experience leading design and qualification of thermal systems, and the ability to collaborate across functions while staying current on industry trends and regulations.

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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