MS&T Technical Manager

Job Description Summary

Lead and manage MS&T activities for assigned CMOs ensuring product performance compliance and continuous improvement. Act as ESO Project Team Lead for new product launches and technology transfers driving cross-functional collaboration and timely quality execution. Additionally lead ESO-wide initiatives and represent MS&T in global networks to support strategic objectives.

Job Description

Job Title

Technical Manager MS&T

Location - Mumbai

Department

Manufacturing Science and Technology (MS&T)

Key Responsibilities :

Lea d a n d m a n ag e a l l M a n u f a c t u r in g Sc i e nc e & Tec hn o l ogy a c t i v i t i e s f or t h e a s s i g n e d

C o n t r a c t M a n u f a c t u r in g O r gan iz at i o n s ( CM O s ) . T hi s in c lu d e s p r ov i d in g p r od uc t stewa r d sh i p b y e n su r i n g t h e pe rf o r m a nc e of a l l NVS p r od uc t s a r e mo ni t o r e d a n d m a in ta in e d i n a va li date d s ta t e su pp o r t in g r oot c a u se in ve st i gat i o n s b y p r ov i d in g MS & T in te l l i ge nc e to de v i at i o n s te chnic a l c ompla in t s OO S & C A PA s i de n t if y in g an d e xec u t in g c o n ti nu o u s i m p r ov e m e n t

o p p o r t uni t i e s .

Acts as the ESO Project Team Lead (PTL) for new product launch at CMOs / technology transfer at CMOs. 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 products remain in a validated state and technical performance is monitored.

Key Accountabilities :

Assess impact of manufacturing changes.

Provide MS&T intelligence for deviations investigations OOE / OOS and technical complaints.

Define and track technical CAPAs from APR / PQR assessments or variances.

Deliver performance capability results and recommended CAPAs.

Identify and execute process optimization opportunities.

Lead product manufacturing remediations.

Establish and execute product revalidation strategies (QRAs validation protocols / reports).

Implement continued process verification strategies and annual verification.

Maintain knowledge for manufacturing of NVS products.

Product Transfers & New Product Launch

Lead cross-functional teams for product transfers / launches to third parties (process technology analytics capacity resources).

Ensure project milestones are achieved on time within budget and with required quality.

Provide technical expertise with manufacturing experts.

Support CMO site selection for technical fit.

Define and monitor technical project scope timing and progress with Giving Site or TRD.

Prepare Manufacturing Process Transfer Documents (protocols reports).

Coordinate feasibility regulatory and validation batches at site.

Initiate monitoring and Continued Process Verification (CPV) phase.

Ensure compliance with cGMP HSE and regulatory standards.

Support continuous process and quality improvements.

Assist QA in inspection readiness (Pre-Approval Inspection).

Desirable Requirements :

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

Education :

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

Highly desirable : MSc. or equivalent experience.

Why Novartis : Our purpose is to reimagine medicine to improve and extend peoples 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 : receive : You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. 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 : 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

Required Experience :

Manager

Key Skills

Mainframe,ABAP,Information Technology Sales,Investment Management,IT Service Desk,Clinical

Employment Type : Full-Time

Experience : years

Vacancy : 1