- Mumbai, India
Our External Supply Operations include 1,000 manufacturers worldwide and handle 3rd party manufacturers for strategic raw materials, drug substances, drug products and finished products.
The Technical Manager will support the Head of MS&T by leading initiatives and/or work-streams and representing ESO/TPO MS&T in various global networks.
Lead and handle all Manufacturing Science & Technology activities for the assigned Supplier Relationship Team (SRT) / Contract Manufacturing Organizations (CMOs). This includes, providing product stewardship by ensuring the performance of all NVS products are supervised and maintained in a validated state, supporting root cause investigations by providing MS&T intelligence to deviations, technical complaints, OOS & CAPAs, identifying and executing continuous improvement opportunities, leading New Product Launch technical teams and leading technical activities related to transfers of Drug Product Manufacture and Packaging.
YOUR KEY RESPONSIBILITIES:
Your responsibilities include, but not limited to:
• The Technical Manager can be assigned to one specific role or combine several, depending on the size of his/her portfolio (e.g. Technical Manager - Product Steward, or Technical Manager - Transfer & NPL, etc). He/she ensures a holistic technical oversight of the activities at the assigned Contract Manufacturing Organizations. The Technical Manager is responsible for establishing a relationship with the MS&T organization of the CMOs and bringing MS&T topics on the agenda of the regular CMO-NVS meetings. The Technical Manager is the technical SPOC for the assigned SRT / CMOs representing ESO/TPO MS&T.
• PRODUCT STEWARDSHIP
As Product Steward, the Technical Manager ensures that the products stay in a validated state and their technical performance/capability is supervised.
Major accountabilities include: assessing impact of manufacturing changes; providing MS&T intelligence to deviations, investigations, OOE's and OOS's, technical complaints; defining and supervising technical CAPAs resulting from APR/PQR assessments or manufacturing variances; providing MS&T intelligence to APR/PQR and delivering the performance capability results, interpretations and recommended CAPAs; identifying process optimization opportunities and executing them when approved; vi) identifying and leading product manufacturing remediations; establishing and executing product revalidation strategies including approval of QRAs, validation protocols and reports; establishing and executing continued process verification strategies and annual verification; ensuring maintenance of knowledge for the manufacturing of NVS products; x) review of QA agreements to ensure that required MS&T deliverables are included.
• PRODUCT TRANSFERS
As transfer technical lead, the Technical Manager is responsible for the successful transfer of the manufacturing process (API, bulk and packaging) and its validation at the receiving site by ensuring subject matter risk assessment and perfection in execution. Technical Manager can assemble and lead a technical sub team. He/she supports site selection Decisions at the ESO/TPO and/or global boards by providing analysis of technologies and manufacturing risk assessment. He/she will i) support setting the timelines and predecessor/successor activities associated with the change or transfer; ii) establish the technical acceptance criteria and technical go/no-go decision points in collaboration with QA and RegCMC; iii) develop Technology Transfer documentation and associated deliverables which may include: updated design documentation, validation plans, specifications, comparability assessments, development plans, other, in accordance with current regulatory requirements and QM; iv) support scope definition and track technical activities.
• NEW PRODUCT LAUNCH
As the new product launch technical lead, the Technical Manager is responsible for the successful transfers of manufacturing and packaging processes from Development into commercial operations at CMOs. He/she manages the ESO/TPO related technical launch and project improvement activities, owns the respective technical sub team and collaborates closely with related functions e.g. R&D, Operations, Supply Chain, other sites. He/she ensures appropriate project management to achieve breakthroughs in time, with required quality and in budget.
• TRAINING & REFERENCE PERSON
The Technical Manager trains the ESO/TPO organization on drug manufacturing and packaging science. He/she maintains a level of excellence by accurate training and can act as a reference person for given technologies. He/she represents the ESO/TPO MS&T organization in global workstreams (e.g. CPV) and other sister organization (e.g. PharmOps MS&T). When several brands are manufactured at various CMOs and/or internally, the Technical Manager can act as a brand reference person and ensures that product specific learnings made at a CMO are reflected (e.g. verify that CAPAs are consistently deployed across CMOs for a same product).
WHAT YOU'LL BRING TO THE ROLE:
• BSc/MSc in a Scientific or Technical discipline. PhD a plus. Excellent knowledge of English and proficient in local language.
• 12+ yrs of experience in a Pharmaceutical manufacturing/technical environment. Strong leadership skills with a minimum of 5 years managerial experience.
• Demonstrated technical expertise in manufacturing science and drug development. Significant knowledge of industry practices and regulations (e.g. GxP, ISO, ICH / VICH, etc.) across multiple health authorities (e.g. FDA, EMEA, Health Canada, etc.) Statistical knowledge required, Lean/Six Sigma Certification preferred.
• Demonstrated leadership and accomplishments in a global/matrix environment in the pharmaceutical industry Strong project management, interpersonal, cross-cultural, communication, negotiation and problem solving skills.
Why consider Novartis?
799 million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
Imagine what you could do at Novartis!
COMMITMENT TO DIVERSITY & INCLUSION:
NOVARTIS EMBRACES DIVERSITY, EQUAL OPPORTUNITY AND INCLUSION. WE ARE COMMITTED TO BUILDING DIVERSE TEAMS, REPRESENTATIVE OF THE PATIENTS AND COMMUNITIES WE SERVE, AND WE STRIVE TO CREATE AN INCLUSIVE WORKPLACE THAT CULTIVATES BOLD INNOVATION THROUGH COLLABORATION, AND EMPOWERS OUR PEOPLE TO UNLEASH THEIR FULL POTENTIAL.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network (https://talentnetwork.novartis.com/network)
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