Technical Services Manager - ReqCode 91606BR

Sandoz, a global leader in the rapidly growing generics industry, is a company in which doctors, pharmacists and patients worldwide have placed their trust for more than 100 years. With about 23 000 employees in more than 130 countries. We save and improve lives by developing, producing and distributing high-quality, affordable pharmaceuticals. That's why choosing Sandoz is always 'a healthy decision'. Sandoz is also playing the pioneer role in the exciting new field of biosimilar medicines (follow-on biologics). We have successfully developed and launched the first ever hGH and EPO biosimilars for the European market.

We are now rapidly expanding our product portfolio and, for our global biopharmaceutical development headquarters in the Munich area, we are looking for highly qualified experts for the following position:
Job Description:Summary:
The manager assures that all activities associated with technical support for the manufacturing operations are technically sound and delivered on time. This position is responsible for developing, maintaining, and implementing the Commercial Product Support program including procedural improvements that maintain compliance with the Code of Federal Regulations, company practices and policies. The manager is responsible for managing the investigation and CAPA programs as related to product/process technical issues. This may require the development and execution of protocols to study/analyze product quality attributes. Direct reports to perform data analyses, write reports to support investigations, and implement assigned corrective and preventative actions. The manager is responsible for directing work related to manufacturing batch record improvements and corrections and to provide appropriate justification for these changes (change control). The Manager Commercial Product Support works in tandem with the Sr. Manager, Process
Optimization to assure that all critical process issues are evaluated and appropriately updated in department documentation. This position actively participates in and represents the Commercial Product Support group at applicable meetings (Material Review Board, Investigation Review Board, etc.). The manager is responsible for all technical aspects of the Product Life cycle management after ANDA approval (Annual Product Report reviews, Alternate Source API qualifications, raw material changes) as well as production improvement programs. The Manager Commercial Product Support develops and leads work plans and provides technical direction to lower level resources. This position creates schedules and work plans for CPS activities.

Responsibilities:
- Provides managerial oversight to the assigned team of Process Optimization Scientists (includes outside contractors/vendors) to direct completion of investigations and CAPAs on time and in compliance.
- Must possess a solid understanding of FDA guidelines and industry best practice for this field and be able to implement these standards on a daily basis. Requires an operating knowledge of pharmaceutical formulation and/or processing. Assigns tasks, reviews work, and writes appraisals.
- Ensures assignments are on schedule, within budget, and performed in accordance with all Sandoz, Novartis, and industry regulations and procedures.
- Assignments are objective based and may require position to design best process/practice to meet objectives.
- Develops/reviews written SOP's, standards, and processes for applicable areas of responsibility.
- Manage resources, budget, materials, and project plans for Alternate Source API projects.
- Develops an efficient and compliant team culture that is learning and continuous ... To view the rest of this job posting or to apply for this position please click the APPLY NOW button