MS&T Technical Manager

Mumbai, Maharashtra
Permanent
Full-time

5 days ago

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 DescriptionGeneralJob TitleTechnical Manager MS&TDepartmentExternal 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 assignedContract 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 AccountabilitiesProduct 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 cGMP, 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 cGMP 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 CpK – process capability.
Degree of standardization of product process
OoS, OoE – 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 DimensionsNumber 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 to
plan
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. 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

Novartis CompetenciesLeadership StandardsFundamentalIntermediateAdvancedThought LeaderSets Clear Direction & Aligns Team & Others Around Common ObjectivesEnergizes The TeamDisplay Passion For The 3CsExercises Good Judgement & Drives Change For Competitive AdvantageDrives For Superior Results & Has Passion To WinBuilds The Talent PipelineInspires Continuous Improvement & Breakthrough ThinkingDisplays Analytical & Conceptual ThinkingFunctional CompetenciesFunctional CompetenciesFundamentalIntermediateAdvancedThought Leader

Manufacturing process science

Manufacturing process technologies

Quality Compliance

Problem Resolution

Project Management

Operations

Finance

IT/Automation

Lominger CompetenciesFundamentalIntermediateAdvancedThought 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-cultureYou’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-rewardsCommitment 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

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