Job Description
Your Key Responsibilities:
Your Responsibilities Include, But Not Limited To
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.
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.
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.
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
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.).
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
Training
- Own the Training Curriculum for its Job Description and direct reports.
Sandoz Manufacturing Manual
- Support implementation of applicable Sandoz Manufacturing Manual practices.
Key Performance Indicators (Indicate how performance for this role will be measured)
- Assigned products can be manufactured reliably and without recurring process-, material-, equipment-issues that would trigger Quality events, such as OOS results, Deviations or Customer Complaints.
- Manufacturing process is robust and maintained in constant state of validation.
- Technical reports executed on time and with the right expectations.
Experiences
What youll bring to the role:
- Proven demonstrated ability of 15+ years in drug substance pharmaceutical development and manufacturing of drug substance biologics (large molecules); comprehensive know how in pharmaceutical technology, project management experience.
- Experience in a global/matrix environment in the pharmaceutical industry.
- Thorough understanding of drug substance biological production processes incl transfers and submissions.
- Comprehensive know how in drug substance biotechnological production processes.
- Strong communication skills.
Youll Receive
Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.
Why Sandoz
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
#Sandoz
