Senior Biologics Engineer III/Associate Director, Technical Operations

Company: Gilead Sciences, Inc.
Location: Oceanside
Posted on: May 26, 2023

Job Description:

Senior Biologics Engineer III/Associate Director, Technical Operations page is loaded Senior Biologics Engineer III/Associate Director, Technical Operations Bewerben locations United States - California - Oceanside time type Full time posted on Vor 3 Tagen ausgeschrieben job requisition id R0035796 For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. 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.
Job DescriptionThis position is responsible for providing technical expertise and leadership to drive successful technology transfer and process validation activities for biologics drug substance manufacturing. Project scope may include introduction of new products to existing external facilities, 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 substance 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 authorities*Travel up to 20% is expected*Responsibilities:

• Lead technology transfer project teams for biologics drug substance manufacturing 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.
• Up to 20% travel time to support the above activities.Qualifications:
  • 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 drug substance process development, technology transfer, and/or manufacturing. Past history managing commercial biologics manufacturing projects including process validation of biological products is highly desirable.
  • Strong understanding of biologics drug substance manufacturing processes e.g., mammalian cell culture in bioreactors, harvest/recovery, downstream purification operations
  • 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 skillsThe salary range for this position is: $157,165.00 - $203,390.00. 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. --hnliche Stellen (1) Senior Biologics Engineer III/Associate Director, Technical Operations locations 2 Standorte time type Full time posted on Vor 3 Tagen ausgeschrieben About Us Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all Canada, Australia, Singapore, and Hong Kong employees and contractors to be fully vaccinated against COVID-19 as a condition of employment. The health of our employees, contractors, their loved ones, our partners and the communities and people we serve is a top priority. Vaccination is the most effective way currently available to deliver on that priority.The purpose of the vaccination requirement is to minimize the spread of COVID-19 in the workplace and support the health and safety of our communities. A person is considered fully vaccinated two weeks after the second dose of a two-dose vaccine or two weeks after 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 an accommodation.

Keywords: Gilead Sciences, Inc., Oceanside , Senior Biologics Engineer III/Associate Director, Technical Operations, IT / Software / Systems , Oceanside, California