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.

About the Role

General

Job Title

Technical Manager MS&T

Department

External Supply Operations - Manufacturing Science and Technology (MS&T)

Reports to (Job Title)

Functional Lead MS&T - ESO

Key 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 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.

Major Accountabilities

P

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c

t

St

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r

d

s

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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 TRDWrites 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 Dimensions

N

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None (may have direct reports depending on Division)

Fin

a

n

ci

a

l

r

e

s

pon

s

i

b

i

l

i

t

y:

(Budget, Cost, Sales, etc.)

I

m

p

a

ct on

t

he o

r

g

a

n

i

z

a

t

i

on:

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 Competencies

Leadership Standards

Fundamental


Intermediate


Advanced


Thought Leader


Sets Clear Direction & Aligns Team & Others Around Common Objectives


Energizes The Team


Display Passion For The 3Cs


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
HSE

Lominger 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.

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network:

Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards:

Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards



Division
Operations
Business Unit
Universal Hierarchy Node
Location
India
Site
Mumbai (Head Office)
Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area
Technical Operations
Job Type
Full time
Employment Type
Regular
Shift Work
No

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.


Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.