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Senior Engineer, Tech Transfer Lead

Vacaville, California
Job Type
15 Feb 2021
The Vacaville Manufacturing Science and Technology, Technology Transfer (MSAT Tech Transfer) group is dedicated to provide scientific and technical support to Genentech Vacaville manufacturing operations. The MSAT Tech Transfer group works in collaboration with Process Engineering, Manufacturing, Process Development, Quality, and other technical and business functions to ensure safe and efficacious mammalian drug substance manufacturing processes. Specifically, the MSAT Tech Transfer group is responsible for technical delivery of drug substance process and product related projects, into the Genentech Vacaville production facility.The open position is for Senior Engineer with tech transfer leadership accountability at receiving manufacturing site to enable successful qualification campaign and licensure of new manufacturing processes at Genentech Vacaville facility. This position also has a support level role in external transfers as well.Job Responsibilities:Lead site transfer team for receiving unit and support donor unit in external transfer teamMonitor and oversee technical activities to enable site transfer execution according to the approved Master Transfer PlanResponsible for timeline completion of receiving unit tech transfer deliverables (such as: process validation, translation of process requirements into manufacturing instructions and process performance metrics reporting)Responsible for information exchange from donor unitResponsible to establish the initial validated state of drug substance manufacturing process transferred to Vacaville - from kick-off to end of Process Performance Qualification (PPQ)Collaborate with SMEs within site transfer team to facilitate information exchange and to clarify operational procedures with SMEs from donor unitPerform a review of all documents transferred to the receiving site during the document transfer step in order to make sure that the documents meet current requirements and standardsDrive resolution activities of technical issues throughout project lifecycle, and ensure timely escalation as neededProvide technical content for CMC sections (e.g. site specific process validation) of regulatory submissionInterface with tech transfer donor unit, Operations, Engineering, and Key Network Partner(s)In addition to core responsibilities, the successful candidate may be requested to support additional technical projects associated with new network and Vacaville site capabilitiesJob Requirements: BS or higher degree in Biological, Chemical or Biochemical Engineering, or related Physical SciencesMinimum of 8 years work experience in cGMP biopharmaceutical production setting (process development and/or manufacturing technical support).Experience in biopharmaceutical manufacturing, including scale-up/scale-down and in commercial setting.Large scale (2 KL+) and Monoclonal Antibody experience a plusExperience with process transfers, process validation, authoring and reviewing regulatory submissions, and health authority inspectionsProficiency in Process Validation approaches, industry practice, and applicable health authorities regulations and guidanceThorough understanding of current Good Manufacturing Practices (cGMPs) as they apply to process operation and process controlPrevious working experience in a matrix-based cross-functional environmentStrong communication skills (verbal and written)Ability to work in a fast-paced and matrix environmentAbility to support international time zone and ability to support occasional travel both domestic and internationalComfortable to work in a cross-cultural and virtual team(s) (colleagues not located at one single place) #LI-AD1 Who we are A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
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  • Job Reference: 232036645-2
  • Date Posted: 15 February 2021
  • Recruiter: Roche
  • Location: Vacaville, California
  • Salary: On Application
  • Sector: Manufacturing Operations
  • Job Type: Permanent