Job Description

Sr. Technical Manager MS&T

Location \xe2\x80\x93 Mumbai #LI Hybrid

About the Role:

Represents the main technical interface between Novartis and external suppliers by providing technical expertise on manufacturing and packaging process design, process- and cleaning-validation and resolution of technical issues. Applies an appropriate level of product and process oversight to ensure product quality and process robustness. Performs the technical due diligence in pre-evaluation phase to select the appropriate external suppliers together with BD&L. Acts as responsible Technical Transfer Lead to facilitate Product Transfers for legacy products as well as new development products from Novartis to external suppliers or between external suppliers. Aligns with the Development organization for manufacturing process design during early stage development. Acts as the MS&T representative in assigned Supplier Relationship Team (SRT). Provides technical / scientific process support to respective Supply relationship teams (SRT) and works in close relation with other SRT members (QA Managers, Site Change Coordinators, Supply relationship Manager etc.) for evaluation of technical compliance activities (Deviations, Change controls, Customer Complaints, CAPAs). Ensures seamless flow of knowledge and information transfer within the organization and across functions with focus on process and product know-how.

Key Responsibilities:

• Establish partnership with external suppliers with focus to ensure and improve product process capability, to keep the knowledge of process up to date and to maintain the product in constant state of validation. Support respective external suppliers with Science- and Risk-based approaches to ensure that product quality can be sustainably reproduced.

• Act as SPOC to maintain the oversight and knowledge for entire manufacturing process throughout the entire commercial lifecycle at given external suppliers. Ensure a proper understanding of manufacturing process and influencing factors (i.e. CQAs, CMAs and CPP) to ensure product quality and process robustness at the commercialization site.

• Analyze product-specific manufacturing data from APQRs and other relevant sources where needed and agree on state of control. Assess impact of technical changes, assess technical feasibility and determine scope / design of technical batches, challenge technical risk and business benefit of proposed technical changes. Contribute to the registration strategy and ensure alignment of (regulatory) timelines for technical changes, transfers, launches & major deviations.

• Lead / support root cause investigation of product and process failures. Effectively liaise with external suppliers to initiate and lead/support product / process remediation / improvement activities, involving cross-functional teams and with clear interfaces to Quality, Operations, Engineering and Technical Development. Maintain Division and/or cross-division networks to share lessons learned and best practices related with process and technologies.

• Responsible for the validation oversight and for maintaining the product in constant state of validation. Challenge defined control strategy based on CQA and where necessary on CPP, CMA. prior to validation and for defined improvement projects. Review respective Quality Risk Analysis (QRA) prior to validation for technical changes.

• Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables and use the output to verify critical process parameters. Review validation protocol and report as appropriate. Provide all necessary information to generate the validation documentation. Support Validation Lead and Experts to assess need and plan validations, assess revalidation need.

• Participate in external supplier / product evaluation and selection process. Responsible for gathering technical information on manufacturing process capability at external supplier. Provide the necessary data for the technical activities involved in transferring out a product through the appropriate documentation, focusing on existing knowledge. Support technical activities at the giving / receiving site as needed.

Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum requirements
Essential Requirements:

• Minimum 15-20 years of experience in pharmaceutical (chemical) manufacturing in Tech transfer projects. Experience managing/working with global CMO\xe2\x80\x99s.
• Experience in a global/matrix environment in the pharmaceutical industry in 3rd party tech transfer
• Comprehensive know how in pharmaceutical (chemical) technology. Project Management experience is preferred.
• Drug Development experience. Sound experience of data handling and applied statistics.

Desirable Requirements:

• B.Sc. in Pharmacy, Pharmaceutical Technology, Chemistry, or equivalent scientific degree. Desirable MSc. or PhD.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people\xe2\x80\x99s 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\xe2\x80\x99ll 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

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.
Division
Operations
Business Unit
SMALL MOLECULES
Country
India
Work Location
Mumbai
Company/Legal Entity
Nov Ind
Functional Area
Technical Operations
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No