Scientist III, Process Develop - ReqCode 92334BR

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:

Design, develop and conduct studies to produce robust bio-equivalent formulas and
processes. Identify and evaluate critical formulation and processing parameters. Conduct
analyses, write reports to support filings, scale-up scientific papers and justification for changing processes.

Leads multiple projects for troubleshooting, process optimization and technical transfer activities. Provides direction to lower-level staff members. Viewed as a technical resource in process development, troubleshooting, process optimization and scale-up. Reviews the work of less-experienced resources and resolves problems. Establishes procedures and specifications. Writes and reviews reports and regulatory documents. Utilize statistical experimental design techniques.

Has thorough understanding of technical concepts required for specialized field. Uses that
knowledge, creativity and company practices and priorities to obtain solutions to complex
problems. Provides work leadership to others. Interfaces with senior management to provide
and obtain information and to build consensus regarding project direction.

The Product Development Scientist is directly responsible for the management and execution of Commercial Product support projects in the areas of product technical transfer, product
improvement and optimization, scale-up, troubleshooting and investigation support.
Leads multiple projects for troubleshooting, process optimization and technical transfer activities. Provides direction to lower-level staff members. Viewed as a technical resource in process development, troubleshooting, process optimization and scale-up.

Responsibilities:

* Performs root cause identification of product related investigations. Leads product transfer projects, transferring specific products from regular production at local site from an
alternate manufacturing site. Leads projects in optimization, improvement, and scale-up.

* Manages alternate source projects for Active Pharmaceutical Ingredients (API's)

* Performs troubleshooting activities for daily support of manufacturing relating to process
and equipment.

* Evaluates and develops new technologies

* Provides assistance/guidance to lower level scientists and technical staff

*Provides off hour on-call support to manufacturing

* Documents findings, authors reports and regulatory documents.

* Requires significant interaction with other functional groups within the site.

* Works under limited supervision of management and/or teams leads

* Understands company goals and objectives and applies them when resolving a variety of problems

* Uses judgment, creativity and sound technical knowledge to obtain and recommend solutions

* Additional duties and assignments as needed ... To view the rest of this job posting or to apply for this position please click the APPLY NOW button