Sr. Biologics Engineer I, Technical Operations
United States - New Jersey - Morris PlainsUnited States - California - Oceanside
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
to apply for this job.Job DescriptionSr. Biologics Engineer I, Technical Operations
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases
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.
- Degree in Chemical Engineering, Bioengineering, Pharmaceutical Sciences or related field, and appropriate years of experience:
- MS with 5+ years of relevant work experience OR BS with 7+ 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.
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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 firstname.lastname@example.org
for assistance.Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, and Singapore employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
For more information about equal employment opportunity protections, please view the 'EEO is the Law'
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
to apply for this job.