VacavilleRecruiter Since 2001
the smart solution for Vacaville jobs

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Make up to $21/hour - Deliver with DoorDash
Description: Your time. Your Goals.What is DoorDashAvailable in over 4,000 cities in the U.S., Canada, and Australia, DoorDash is about connecting people with possibilities: bigger savings accounts, wider nets, stronger (more...)
Company: Doordash
Location: San Ramon
Posted on: 01/21/2021

Make up to $21/hour - Deliver with DoorDash
Description: Your time. Your Goals. br What is DoorDash br Available in over 4,000 cities in the U.S., Canada, and Australia, DoorDash is about connecting people with possibilities: bigger savings accounts, (more...)
Company: Doordash
Location: San Ramon
Posted on: 01/21/2021

Asset Protection Specialist
Description: Job Description The Asset Protection Specialist is primarily responsible
Company: The Home Depot
Location: Santa Cruz
Posted on: 01/21/2021


Make money from home with Neighbor
Description: Neighbor Parking Storage Host Rent out your parking space or your garage and earn 4,000 / year We are looking for side hustlers and passive income lovers to join Neighbor as independent hostsNeighbor (more...)
Company: Neighbor
Location: San Rafael
Posted on: 01/21/2021

Asset Protection Specialist
Description: Job DescriptionPosition Purpose:The Asset Protection Specialist is primarily responsible for preventing financial loss caused by theft and fraud and supporting safety and environmental
Company: The Home Depot
Location: Santa Cruz
Posted on: 01/21/2021

Outpatient Counselor
Description: Join the world's leading online therapy platform and provide care on your schedule, all from the comfort of home.What is Talkspace Talkspace is an online therapy platform that will connect you with clients (more...)
Company: Talkspace
Location: Woodland
Posted on: 01/21/2021

Auto Tech II
Description: We call our club's vision, mission, values, and supporting pillars Our House because they are the foundation for all that we do. We're working to transform AAA for the next century with a mission to (more...)
Company: AAA Northern California, Nevada & Utah
Location: San Rafael
Posted on: 01/21/2021

Teller/MSR I
Description: Working for Pacific Service Credit Union br We put people first. That includes our members, our employees and the communities we serve. We hire energetic and enthusiastic people who want to work as (more...)
Company: Pacific Service Credit Union
Location: San Ramon
Posted on: 01/21/2021

Postmates - Earn Extra Cash
Description: Postmates has the largest on-demand fleet in the U.S. with 200,000 Postmates, and an equally extensive network of merchants. While some companies try to build a warehouse outside of a city and funnel (more...)
Company: Postmates
Location: West Sacramento
Posted on: 01/21/2021

Resident Assistant (RA Assisted Living) - San Rafael
Description: Req ID 2020-1787Job Category Clinical ServicesShift NOC, On-CallWho We AreAn Elder Care Alliance CommunityAlmaVia of San RafaelDo you enjoy working with seniors Do you want to work in a setting where (more...)
Company: Elder Care Alliance
Location: San Rafael
Posted on: 01/21/2021

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Vacaville RSS job feeds