This is an exciting opportunity within the Drug Substance Global Biologics Manufacturing Sciences and Technology (DS GBMSAT) department in the Pharma Technical Development organization. GBMSAT provides technical leadership to develop solutions in support of commercial manufacturing across the internal and external Roche network. GBMSAT plays a critical role in enabling the network concept for the MSAT network across Roche. Additionally, GBMSAT provides technical leadership for technology transfers to contract manufacturing organizations.
o Provide technical leadership for manufacturing process changes, process validation, discrepancy and investigation evaluations, change control, and regulatory submissions. Supervision of lab work may be required in order to resolve investigations and/or demonstrate proof-of-concept for proposed process changes.
o Lead and/or participate in global initiatives and cross-functional teams comprised of subject matter experts in the areas of commercial process stewardship, best practice development, troubleshooting and manufacturing process improvements and innovation.
o Lead product introductions into Contract and Roche partner manufacturing as technical Subject Matter Expert (SME), as well as technology transfer between Roche Biologics Drug Substance Manufacturing sites.
o Responsible for authoring, reviewing, and approving technical reports, manufacturing instructions, process validation documents, and portions of regulatory submissions to support licensing processes at new manufacturing sites.
o Responsible for providing ongoing technical support for processes that are currently being manufactured at contract and partner sites. Includes support of discrepancies, investigations, and change control; process data review; and representation of external sites on Product Technical Teams.
o Work proactively to collaborate across the global MSAT network to identify and communicate standards and best practices for process design and manufacturing to ensure consistency across the biologics manufacturing facilities.
o Represent MSAT Network on corporate initiatives led by partner groups such as Quality, Regulatory, Manufacturing Operations, Pharma Technical Development, etc.
o Travel (up to 25%) within the Roche network and to contract manufacturing sites will be required.
Who You Are
o BS/MS/PhD in Chemical/ Biochemical Engineering or Life Sciences with at least 8 years relevant industrial or academic experience (including advanced studies) in bioprocess development or in supporting manufacturing operations.
o Sound background in large-scale processing and engineering fundamentals as applied to drug substance manufacturing processes. Prior experience in recombinant protein purification processes is desired.
o Demonstrated experience in pharmaceutical quality systems and industry-wide guidelines pertinent to biologics drugs substance process development and manufacturing (such as ICH guidelines, regulatory guidelines for process development and validation).
o Demonstrated experience with transferring processes and/or with process validation.
o Motivated, able to work independently as well as in teams. Excellent organization and communication skills (both written and verbal).
o Ability to work in a global environment including capability to support domestic and international travel.
o Demonstrated experience leading teams, experience leading teams with remote membership is also a plus.
o Proven ability to influence beyond direct line reporting relationships including to senior management.
o Experience with statistics in the areas of statistical process control, modeling and data management is desired.
o Experience with tools and techniques of formal process management and improvement methodologies (Operational Excellence, Class A, LEAN production) a plus.
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.
The next step is yours. To apply today, click on the "Apply online" 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.