Senior Engineer, Tech Transfer Lead

Company: GENENTECH
Location: Vacaville
Posted on: January 15, 2021

Job Description:

The Position 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 team Monitor and oversee technical activities to enable site transfer execution according to the approved Master Transfer Plan Responsible 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 unit Responsible 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 unit Perform 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 standards Drive resolution activities of technical issues throughout project lifecycle, and ensure timely escalation as needed Provide technical content for CMC sections (e.g. site specific process validation) of regulatory submission Interface 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 capabilities Job Requirements:BS or higher degree in Biological, Chemical or Biochemical Engineering, or related Physical Sciences Minimum 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 plus Experience with process transfers, process validation, authoring and reviewing regulatory submissions, and health authority inspections Proficiency in Process Validation approaches, industry practice, and applicable health authorities regulations and guidance Thorough understanding of current Good Manufacturing Practices (cGMPs) as they apply to process operation and process control Previous working experience in a matrix-based cross-functional environment Strong communication skills (verbal and written) Ability to work in a fast-paced and matrix environment Ability to support international time zone and ability to support occasional travel both domestic and international Comfortable to work in a cross-cultural and virtual team(s) (colleagues not located at one single place) Who We Are Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We're focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work. The next step is yours. To apply today, click on the "Apply for this job" button. Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page . Job Facts JOB FUNCTION Production Engineering COMPANY/DIVISION Pharmaceuticals SCHEDULE Full time JOB TYPE Regular

Keywords: GENENTECH, Vacaville , Senior Engineer, Tech Transfer Lead, Other , Vacaville, California