Location
Hyderabad | India
Job description
About the role
2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, passionate organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!
Together we will shape the future of Sandoz… are you ready to make a difference?
Job Purpose:
Represents the main technical interface between Sandoz 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 Sandoz 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
1. Technical Interface to external supplier:
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.
2. Product/Technical Stewardship for defined key molecules:
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 and/or 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.
3. Validation – for product(s) in scope:
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.
4. Launch & Transfer– for product(s) assigned:
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.
Define product acceptance criteria for the transfer, agree on acceptable performance with receiving organization and monitor routine manufacturing performance following transfer. Ensure successful and well-documented transfers and launches of products with external manufacturing involvement. Active support for Product Launch and Transfer governance processes
5. 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
Support development of comprehensive control strategy early on in the development to ensure that validation requirements meet regulatory requirements and other critical metrics (e.g., quality, safety, environmental, cycle times, etc.).
6. Manufacturing Excellence – for defined product(s):
Define and execute design and control optimization projects where needed.
Provide SME expertise to perform process characterization of pharmaceutical processes to increase robustness and sustainability.
7. Training:
Own the Training Curriculum for its Job Description and direct reports.
8. Sandoz Manufacturing Manual:
Support implementation of applicable Sandoz Manufacturing Manual practices.
Role Requirements
What you’ll bring to the role:
Education (minimum/desirable):
BSc. In Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree.
Desirable MSc. or PhD.
Languages: Fluent in English.
Relevant Experiences:
Minimum 5 years of experience in pharmaceutical (chemical) manufacturing.
Experience in a global/matrix environment in the pharmaceutical industry
Comprehensive know how in pharmaceutical (chemical) technology.
Project Management experience
Drug Development experience
Sound experience of data handling and applied statistics
Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2021and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could achieve here at Sandoz!
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.
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