Ms&t Technical Manager

Job Description Summary Lead and manage all Manufacturing Science & Technology activities for the assigned Contract Manufacturing Organizations (CMOs).

This includes providing product stewardship by ensuring the performance of all NVS products are monitored 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. Acts as the ESO Project Team Lead (PTL) for new product launch at CMO's / technology transfer at CMO's.

Assembles and leads a cross-functional team to ensure the successful transfers of manufacturing at CMOs.

Ensures appropriate project management to achieve milestones in time, with required quality and in budget by leading the respective technical sub-team and liaising efficiently with related functions. Supports the MS&T organization by leading ESO-wide initiatives and/or work-streams and representing ESO MS&T in various global networks. Job Description General Job Title Technical Manager MS&TDepartment                External Supply Operations - Manufacturing Science and Technology (MS&T)Reports to (Job Title) Functional Lead MS&T – ESOKey Responsibilities: Lead and manage all Manufacturing Science & Technology activities for the assigned Contract Manufacturing Organizations (CMOs).

This includes providing product stewardship by ensuring the performance of all NVS products are monitored 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 improvementopportunities.

Acts as the ESO Project Team Lead (PTL) for new product launch at CMO's / technology transfer at CMO's.

Assembles and leads a cross-functional team to ensure the successful transfers of manufacturing at CMOs.

Ensures appropriate project management to achieve milestones in time, with required quality and in budget by leading the respective technical sub-team and liaising efficiently with related functions.

Supports the MS&T organization by leading ESO-wide initiatives and/or work-streams and representing ESO MS&T in various global networks.

Major Accountabilities Product Stewardship 
• As Product Steward, ensure that the products stay in a validated state and their technical  performance/capability is monitored.
• Major accountabilities include:  -  Assessing impact of manufacturing changes.  -  Providing MS&T intelligence to deviations, investigations, OOE's and OOS's, technical     complaints.  -  Defining and tracking 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;  -  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.  Product Transfers and New Product Launch 
• Leads a cross functional team for product transfers/launches to 3rd parties (process,    technology, analytics, capacity, resources). 
• Ensures appropriate project management to achieve milestones in time, with required quality    and in budget by leading the respective technical sub-team and liaising efficiently with related    functions. 
• Provides technical expertise together with manufacturing experts. 
• Supports CMO site selection and ensure right technical fit for transfer/launch 
• Defines and monitors technical project scope, timing and progress in collaboration with Giving    Site or TRD 
• Writes Manufacturing Process Transfer Documents (protocol, report). 
• Coordinates feasibility, regulatory and validation batches at site. 
• Initiates monitoring and Continued Process Verification CPV phase. 
• Ensures that all activities are performed to current standards (current Good Manufacturing    Practices c GMP, Health Safety Environment HSE, Regulatory etc.). 
• Supports continuous process and quality improvements. 
• Supports QA to ensure inspection readiness (Pre Approval Inspection PAI).                                                       Essential Requirements: Technical transfer milestones achieved on time and in full, including schedule for registration and launches.

Robust manufacturing process at CMO, delivering critical quality attributes.

Analytical methods in place, meeting c GMP standards.

No critical observations during internal and external GMP inspections and Pre-Approval Inspections (PAI). Adheres to project / Capital Approval Request CAR costs.

Recognized as an excellent collaborator and partner by the CMOs, SRTs, QA and others partner functions (R&D)When acting as Product Steward, meet related KPIs: Product is maintained in constant state of validation.

Product history is documented and available and current since transfer from development/transfer to CMO to date.

Recurring Deviations.

Continuously improving Cp K – process capability.

Degree of standardization of product process Oo S, Oo E – Out of Specification, Out of Expectation.

Customer Complaints.

Recalls.
Success rate of Health Authorities' inspections.

Completeness of Reg CMC dossier Effective CAPA.

Continuously improving Yield.

Technical reports executed on time and with the right expectations.

Job Dimensions Number of associates: None (may have direct reports depending on Division)Financial responsibility:(Budget, Cost, Sales, etc.)Impact on the organization: Strengthen   product/process   manufacturing   performance, reducing product quality complaints.

Improve Supply Chain performance by increasing process robustness, minimizing recalls, rejected batches and write- offs.

High Ensures that Novartis products manufactured at CMOs meet stay in a validated state, are trended and optimization potential are implemented.                              Ensures Transfers and launches are executed according toplan Contribute to ESO Manufacturing financial /business/quality goals.

Minimize rejected batches and write-offs.

Maximize Yield improvements.

Desirable Requirements: Education: BSc / MSc.

/ BTech or MTech (Chemistry / Chemical Technology) or equivalent scientific degree.

Highly desirable: MSc.

or equivalent experience.

Language: Fluent in English Experience:             10 yrs of experience in a pharmaceutical manufacturing-API/technical environment/Technology transfer and project management.

Strong leadership skills with a minimum of 5 years managerial experience Demonstrated technical expertise in manufacturing science and drug development.

Project management skills Significant knowledge of industry practices and regulations (e.g.

Gx P, 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 Novartis Competencies Leadership Standards Fundamental Intermediate Advanced Thought Leader Sets Clear Direction & Aligns Team & Others  Around Common Objectives Energizes The Team Display Passion For The 3 Cs Exercises Good Judgement & Drives Change For Competitive Advantage Drives For Superior Results & Has Passion To Win Builds The Talent Pipeline Inspires Continuous Improvement & Breakthrough Thinking Displays Analytical & Conceptual Thinking Functional Competencies Functional Competencies Fundamental Intermediate Advanced Thought Leader Manufacturing process science Manufacturing process technologies Quality Compliance Problem Resolution Project Management Operations Finance IT/Automation HSELominger Competencies Fundamental Intermediate Advanced Thought Leader Decision Quality Problem Solving Functional/Technical Skills Technical Learning Integrity and Trust Intellectual horsepower       Planning Drive for Results Total Work Systems Action Oriented Process Management Strategic Agility Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world.

How can we achieve this? With our people.

It is our associates that drive us each day to reach our ambitions.

Be a part of this mission and join us Learn more here: https://www.novartis.com/about/strategy/people-and-culture You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

https://www.novartis.com/careers/benefits-rewards Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network. Skills Desired Applied Statistics, Assembly Language, Change Control, Chemical Engineering, Continual Improvement Process, Cost Reduction, Data Analytics, Electronic Components, General Hse Knowledge  , Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Manufacturing Technologies, Process and Cleaning Validation, Process Control, Process Simulation, Risk Management, Root Cause Analysis (RCA), Scientific Method, Six Sigma, Statistical Analysis, Technology Transfer

---