Associate Director, 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:
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to apply for this job.Job DescriptionAssociate Director, 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 and leadership to drive successful technology transfer and process validation activities for a portfolio of biologics drug products. 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. The individual will collaborate with process development and quality partners to ensure processes are robust and well characterized prior to initiation of validation activities. They will supervise other engineers in the execution of process transfers, maintaining company expectations for technical oversight, risk management, and strategic execution.
The individual will serve as process owner during commercial technology transfer activities, leading workstreams including facility fit & gap assessments, capital improvements, risk assessments, control strategy definition, and process validation. They will also serve as a key functional representative in leading CMOs on establishing commercial manufacturing processes for Gilead products, implementing continuous process verification, and providing technical leadership during quality investigations and pre-approval inspections. The incumbent will work closely with Regulatory Affairs in preparation/coauthoring of regulatory filings (CTA, BLA, MAA) and addressing questions from health authoritiesResponsibilities:
- Lead technology transfer project teams for sterile fill/finish processes, providing oversight for activities including process transfer and validation. Lead or supervise individuals leading 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 change management procedures 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.
- Provide supervision and training to junior staff members. Identify opportunities for growth and participate in performance management and career development activities.
- Contribute to the development and maintenance of business processes supporting commercial technical operations including risk management practices, technical assessments, performance metrics.
- Support site selection activities by providing technical assessments of supplier capabilities.
- Participate and/or lead cross functional business and scientific initiatives representing Commercial Technical Operations organization.
- Degree in Chemical Engineering, Bioengineering, Pharmaceutical Sciences or related field, and appropriate years of experience:
- Ph.D. with 2 years of relevant work experience, OR MS with 8+ years of relevant work experience, OR BS with 10+ years of relevant work experience.
- Experience supporting and leading sterile product development, technology transfer, and/or manufacturing. Past history managing commercial biologics manufacturing projects including 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 lyophilization.
- Familiarity with regulatory filings (Module 3) and experience authoring submissions and responding to regulator questions. Experience with health authority inspections is a plus.
- Previous experience leading project teams and/or managing staff is preferred.
- 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.
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For Current Gilead Employees and Contractors:
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