Global Head PT Drug Substance Manufacturing Unit

Hoffmann-La Roche Inc. South San Francisco , CA 94080

Posted 2 months ago

We Make Medicines

Behind every product sold by Roche is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at 11 locations around the world.

Are you passionate about manufacturing and looking for a meaningful role?

Are you a leader who can create and share an inspiring vision, who can coach leaders and teams to be better, who is a catalyst for change and world class performance, and who knows how to create the architecture that enables their network to be the best in the industry?

The Global Head PT Drug Substance Manufacturing Unit position offers a unique and exciting opportunity for a senior executive to enable, coach, lead and inspire people in the network with the largest Biologics Drug Substance capacity, with 6 sites with global reach in Asia, North America and Europe.

Reporting to the Head of Pharma Global Technical Operations, you will be a member of the PT Leadership team. By leading an agile organization with a mindset and culture that engages our employees to bring our medicines and services to more patients faster, you will be able to impact how as a company we ensure long term sustainability in manufacturing excellence. Your ability to inspire people to do their best work and be committed to continuing our cultural evolution, in addition to the ability to transparently share your own personal transformation, learnings and vision will enable a high performing organization where the value of manufacturing is optimized.

Your key duties and responsibilities will include:

  • Build and lead a world-class drug substance manufacturing operations team to realize the company's manufacturing strategy of a reliable, flexible, agile and integrated manufacturing network

  • Accountable for the day to day operations, quality and business aspects of performance of the drug substance network ensuring highest compliance standards

  • Accountable for a reliable, cost effective drug substance site network in support of the Long Range Plan, in collaboration with Global Head of Drug Product Manufacturing, Global Head of PT Supply Chain, Global Head of Quality and Compliance, and the Global Head of Pharma Technical Operations

  • Responsible for site selection strategy and decisions and implementation of drug substance plans

  • Accountable to develop risk mitigation plans regarding the drug substance network

  • Oversee drug substance materials management, portfolio management, and training and operational excellence support

  • Work across drug substance internal and external sites and internal business process teams to develop and realize consistent robust, reliable, world-class drug substance manufacturing business processes

Who you are

  • Servant and creative senior leader, motivated by our shared purpose, to generate value and impact beyond the sum of our individual contributions

  • Ability to coach a team of high performing leaders, catalyzing their performance to be better than the individual contributions

  • Minimum 15 years manufacturing management experience in biotech or Pharma industry, preferably with experience leading manufacturing sites and the ability to lead large, complex global organizations; experience with Lean Production Systems and operational excellence

  • Bachelor's in Life Sciences, Business or Engineering, Master in Business or Life Science preferred

  • Technical Experience in at least one of the following: Quality and/or Sterile Processing, Biotechnology production, Pharmaceutical dosage and packaging, Negotiation and Contract Manufacturing

  • Ability to lead and build diverse teams, develop talent and create a working culture that is transparent and values driven to accelerate the personal growth of employees

  • Ability to build trusted relationships both internally and externally through authenticity, accountability, and respect for others

  • Demonstrated global and cross-functional leadership through effective influencing, collaboration and cultural awareness both internally and externally

  • Demonstrated innovative, forward-thinking, strategic agility to create a vision and plans for the biologics manufacturing network

  • Highly collaborative, able to engage, motivate and inspire teams to deliver extraordinary results

  • Solution driven and courageous; empowering decision maker

  • Outstanding business and operational manufacturing leadership capabilities, including the realization of operational excellence programs to improve reliability

  • Engrained quality, safety and compliance mindset

  • Strong financial business acumen

  • Ability to set and achieve bold milestones through cross-functional teams

If you still have questions, please check our FAQs and videos on

Roche is an equal opportunity employer.

Manufacturing, Manufacturing > General Manufacturing

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Engineer Global Manufacturing Science Drug Substance

Hoffmann-La Roche Ltd

Posted 1 week ago

VIEW JOBS 10/7/2019 12:00:00 AM 2020-01-05T00:00 Senior Engineer, Global Manufacturing Science Job Summary: The Pharma Technical Operations (PT) Innovation, Technology, and MSAT (PTI) group takes bold steps to modernize technical operations so Roche can deliver medicines for patients more quickly, efficiently and reliably. In partnership with PT colleagues, we shape and accelerate technology innovation for tomorrow, while standardizing and driving operational excellence in PT today. The PTI - Manufacturing (PTIM) group focuses on accelerating implementation of new technologies within the Roche drug substance manufacturing network, as well as on driving network alignment, standardization, continuous improvement, and risk mitigation activities across manufacturing sites. We are searching for someone to lead feasibility and pilot phase technology projects in the Drug Substance network, and finding resolution of manufacturing/quality issues. As part of an agile team, you will support Roche initiatives and cross-functional teams of subject matter experts to provide technical support for Regulatory, Compliance and Quality. Job Responsibilities: * 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 innovation. * Work collaboratively across the MSAT network to identify and communicate standards and best practices for process design and manufacturing to ensure consistency across the biologics cell culture and/or purification manufacturing facilities. * Represent MSAT Network on corporate initiatives led by partner groups such as Quality, Regulatory, Manufacturing Operations, Pharma Technical Development, etc. * Provide network technical leadership for topics including support for manufacturing process changes, process validation, cross-site discrepancy and investigation evaluations, change control, and regulatory submissions. Some lab work may be required in order to resolve investigations and/or demonstrate proof-of-concept for technology feasibility and proposed process changes. * Facilitate new technology introductions into Roche network manufacturing, as well as technology transfer between Roche Biologics Drug Substance Manufacturing sites. * Responsible for authoring and reviewing technical reports, manufacturing instructions, process validation documents, and portions of regulatory submissions to support licensing processes at new manufacturing sites. * Responsible for providing ongoing cross-site technical support and leadership to enable standardization, continuous improvement, and productivity gains for processes that are currently being manufactured at Roche network sites. Includes support of multi-site discrepancies, investigations, and change control; process data review; and representation on or leadership of network technical teams. * Ability to travel within the Roche network and to manufacturing sites of external vendors and suppliers. Qualifications/Requirements: You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point. * BS/MS/PhD. In Chemical/ Biochemical Engineering or Life Sciences with at least 5+ years relevant industrial experience in cell culture and/or purification and/or E. coli process development or in supporting manufacturing operations. * Demonstrated experience with new technology introduction, transferring processes, and/or with process validation. Previous experiences in material science, cleaning/sterilization/adventitious agent control, direct materials, or process analytics/economics is beneficial. * Demonstrated experience in pharmaceutical quality systems and industrywide guidelines pertinent to biologics drugs substance process development and manufacturing (such as ICH guidelines, regulatory guidelines for process development and validation). * Experience with tools and techniques of formal process management and improvement methodologies (Operational Excellence, Lean Manufacturing) is a plus. * Sound background in large-scale processing and engineering fundamentals as applied to cell culture and/or purification processes. * Experience with digital/data science tools and programming languages especially in the context of biopharmaceutical applications will be considered a strong plus (ex. R, Python, OSI PI, Matlab, etc.) This position requires international travel up to 15-25%, within the Roche network and to external vendor and supplier manufacturing sites. Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be. Roche is an equal opportunity employer. Roche is an equal opportunity employer. Manufacturing, Manufacturing > Production Engineering Hoffmann-La Roche Ltd South San Francisco CA

Global Head PT Drug Substance Manufacturing Unit

Hoffmann-La Roche Inc.