Job description
For Current Gilead Employees and Contractors:
Please log onto your
At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Internal Career Site
to apply for this job.
Job Description
Biologics Engineer III, Technical Operations
This position is responsible for providing technical expertise to drive the successful technology transfer and process validation activities for commercial biologics drug product manufacturing processes. Project scope may include introduction of new products to existing internal/external filling lines, transfer to new contract manufacturing partners, and scale-up/scale-out of products at existing suppliers. The incumbent will engage and collaborate with internal and external partners to ensure drug product process transfers are executed to ensure technical and regulatory success. They will support the design and execution of validation studies during process performance qualification (PPQ) and contribute to authoring of process transfer documents, risk/gap assessments, validation protocols/reports, and regulatory filings. The individual will also serve as a key subject matter expert during PPQ, quality investigations, and/or pre-approval inspection (PAI).
Responsibilities:
-
Represent Commercial Technology Transfer group on project teams as a subject matter expert for sterile fill/finish activities including process transfer and validation. Participate in and/or lead project workstreams such as facility fit, risk assessments, control strategy development, validation strategy.
-
Collaborate with Process Development group to support process characterization activities and establishment of design space to support commercial tech transfer and validation. Participate in internal development teams as Commercial Technical Operations representative.
-
Review and approve technical documentation including protocols, master batch records, and reports for engineering runs, GMP and PPQ campaigns.
-
Author process validation sections of regulatory filings in support of commercial launch/expansion. Ensure regulatory inspection readiness and product compliance with regional regulatory requirements.
-
Implement business and quality procedures for change management to ensure timely and successful technology transfer activities. Partner with product development, manufacturing, quality, and regulatory during investigations to address OOS, OOT, and complex deviations.
-
Participate in cross functional business and scientific initiatives as the Commercial Technical Operations representative.
Qualifications:
-
MS with 3+ years of relevant work experience OR BS with 5+ years of relevant work experience.
-
Experience supporting sterile product development, technology transfer, and/or manufacturing. Past history with process validation of biological products is highly desirable.
-
Process development and operations experience/expertise in drug product manufacturing processes including bulk freeze/thaw, mixing/pooling, filtration, filling and/or lyophilization.
-
Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
-
Excellent and effective verbal and written communication skills.
The salary range for this position is: $101,830.00 - $131,780.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact
careers@gilead.com
for assistance.
For more information about equal employment opportunity protections, please view the
'Know Your Rights'
poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please log onto your
Internal Career Site
to apply for this job.
caravetterealestate.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, caravetterealestate.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, caravetterealestate.com is the ideal place to find your next job.