Job Description Summary
Leads the oversight of technical activities at the external suppliers or partners in the Small Molecules organization, which is responsible to maintain and improve the scientific oversight of the manufacturing processes and technical changes, the relevant technical knowledge and capabilities and to ensure the product and technical stewardship, across all the suppliers
Job Description
Leads the oversight of technical activities at the external suppliers or partners in the Small Molecules organization, which is responsible to maintain and improve the scientific oversight of the manufacturing processes and technical changes, the relevant technical knowledge and capabilities and to ensure the product and technical stewardship, across all the suppliers.
Your Key Responsibilities:
Your responsibilities include, but not limited to:
- Act as SPOC for Global ESO MS&T for all MS&T related topics
- Support SRM’s in setting of objectives and develops vision for ESO MS&T organization of platform
- Establish and maintain MS&T organizational capability and governance processes across ESO to ensure products and technologies are within validation and current technology standards.
- Assess MS&T capabilities in the ESO platform (e.g. organizational set-up, resource availability, availability of technical capabilities, succession plans, reporting together with the respective SRM). Drive a culture of quality and compliance across the ESO MS&T organization.
- Work with the other STO MS&T platform / cluster heads, councils / boards and networks to drive reapplication of standard work processes and best practices. Ensure that quality and compliance improvement as well as savings opportunities are rapidly re-applied across ESO. Ensures implementation of global MS&T initiatives and standards across all STO SRTs.
- Ensures exchange of know-how and best practices within STO MS&T and also across platforms. Support and guide all the ESO MS&T Technical Managers to ensure capable processes by maintaining and improving the scientific oversight of the manufacturing processes and capabilities of Sandoz products at CMOs & BDL Suppliers.
- Support and guide all the ESO MS&T Technical Managers to ensure capable processes by maintaining and improving the scientific oversight of the manufacturing processes and capabilities of Sandoz Active Pharmaceutical Ingredients at CMOs & BDL Suppliers.
- Steer the priorities of Technical Activities wrt BDL Deal evaluations, New Product Launches, Tech Transfers & Major Post approval Changes & WPP remediation globally to ensure seamless supply of products to patients
- Ensure the product stewardship in all phases of product lifecycle (technical changes, knowledge and capabilities).
- Key Performance Indicators (Describe, how performance for the specific role will be measured) PpK – process capability, OoS, – Out of Specification, Customer Complaints, Recalls, Overdue Deviations. Success rate of Health Authorities' inspections, Effective CAPA, Yield, Technology transfers and new product launches on time, right first time. Technical reports executed on time and with the right expectations. Fulfilment of Validation Master Plans. Product and process improvements according to plan. Annual Dept. Budget managed effectively. Succession plan for ESO Region MS&T Head in place and robust. Technical training program in place,
What you’ll bring to the role:
Essential Requirements:
- Post Graduate in Pharmacy/Biology/Chemistry/Relevant Life Sciences/ Ph.D. in Pharmaceutical Technology (preferred)
- 12 -15 years of relevant experience in manufacturing. Additional specialist experience is preferred (e.g, pharmaceutical formulation, process development, manufacturing technology).
- Proven experience driving quality and compliance in an organization.
- Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
- Fundamental understanding of standard pharmaceutical analytical testing.
Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.
Our momentum 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 careers, where diversity of thought is welcomed and where personal growth is supported!
Join us, help us make healthcare fairer and faster.
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.
#Sandoz
Skills 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
