Job Description

About the role:

We are seeking a Technical Manager to help us reach twice as many renal patients twice as fast. In this role, you will be responsible for being the primary point of contact in our customer centric model, engage and identify shared priorities and meet customer\'s needs through problem-solving techniques in order to improve patient outcomes.
This role will work directly with the NHPL ESO Tech Ops (Technical interface) team and reports to the Head of Supplier Relationship Management\xe2\x80\x9d

Key Responsibilities:

• 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 and Acts as the MS&T representative in assigned Supplier Relationship Team (SRT). Provides technical / scientific process support to respective Supply relationship teams (SRT)
• 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).
• Product/Technical Stewardship for defined key molecules and 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.

Minimum requirements

Essential Requirements:

• Analyze product-specific manufacturing data from APQRs and other relevant sources where needed and agree on state of control Support respective external suppliers with Science- and Risk-based approaches to ensure that product quality
• Validation for product(s) in scope Responsible for the validation oversight and for maintaining the product in constant state of validation. Manufacturing Excellence - for defined product(s). Define and implement design and control optimization projects where needed
• Challenge defined control strategy based on CQA and where necessary on CPP, CMA. prior to validation and for defined improvement projects and hands on to formal stage gates during development and up to first APR/PQR, ensure early integration and to ultimately meet manufacturing requirements
• Launch & Transfer for product(s) assigned Participate in external supplier / product evaluation and selection process. Responsible for capturing technical information on manufacturing process capability at external supplier.
• Review respective Quality Risk Analysis (QRA) prior to validation for technical changes and Interface to Development for the product(s) assigned. Ensure that new products and processes are well developed for the commercial scale and the entire product lifecycle at the commercialization site
• Provide input to formal stage gates during development and up to first APR/PQR as part of the development process to ensure early integration and to ultimately meet manufacturing requirements
• Provide SME expertise to perform process characterization of pharmaceutical processes to increase adaptability and sustainability

Desirable:

• University degree in BSc, MSc. Or PhD in pharmacy, pharmaceutical technology, chemistry or equivalent scientific degree. Fluent written and spoken skills English
• Minimum 10+ years\' experience in pharmaceutical (chemical) manufacturing/Industry in a global/matrix environment, API, hands on to Pharmaceutical (chemical) technology, Project Management, Drug Development, Deviation handling (CAPA), Data handling and applied statistics

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 can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Imagine what you could do here at Novartis!

India - 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 diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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

Functional Area

Technical Operations

Division

Operations

Business Unit

SMALL MOLECULES

Employment Type

Regular

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.

Shift Work

No

Early Talent

No

Novartis