Senior/principal Research Scientist
vor 3 Monaten
Education : EQUIVALENTEXPERIENCE
**As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.**
The Senior/Principal Research Scientist (M/F/d) will provide and ensure technical and scientific oversight of assigned APIs in EEM-API scope as a member of Joint Process Teams. Role to ensure technical and scientific excellence and effective production across portfolio of assigned products to maintain and improve product process capability, quality and compliance. The Senior / Principal Research Scientist TSMS may lead, oversee or support launches impacting EEM-API, technology transfers and/or significant EEM network and cross network initiatives.
- Principles of process validation, on-going monitoring / continued verification and process capability. Incumbent is to ensure adherence to governance processes in place for validation and for successful execution of the MR process.
- Complex transfer projects, in particular when scope includes multiple products and /or manufacturing processes.
- Screening of existing and future API portfolio for production-related improvement opportunities.
- Supply strategy activities, i.e. supporting RFPs, product life cycle project design.
- Support and provide scientific expertise for complex deviation investigations including design of experiments to identify underlying root causes.
**Responsibilities**:
- Support and/or lead new product introductions and technical transfer of existing processes within and between internal / third parties.
- Participate in Joint process team (JPT) meetings as primary TSMS; ensure technical requirements of global standards are met.
- Screen existing and future API portfolio for improvement opportunities and write proposals
- Change management.
- Maintain oversight of key batch processing records used at CMs, including SOP’s, Master Production Records, SPI’s.
- Write technical reports to convey status of key initiatives, and to communicate process metrics.
- Maintain oversight of key batch processing records used at CMs, including SOP’s, Master Production Records, SPI’s.
- Write technical reports to convey status of key initiatives, and to communicate process metrics.
- Participate in site visits to the CM, to assess ongoing capability and, as required, to support resolution of complex scientific issues and/or support implementation of significant process or procedural changes.
- Ensure that assigned products have an appropriate control strategy.
- Generate and review Annual Product Reports (APRs) / PQR’s together with QA functions.
- Prepare or coordinate potential technical inquiry Position Papers / Technical briefing documentation within network for support of submissions, internal inspections or Health Authorities related to key products in scope.
- Effectively mentor, coach and develop less senior TSMS scientists and engineers located within the hub and throughout the region.
- Support product recalls.
- Working closely with the Network and Hub TS/MS Leads and Operations, support significant investigations related to deviation & complaints.
**Education**:
- An advanced university degree (M.A. or PhD) or demonstrated career experience in life science or engineering (e.g. pharmacy, chemistry, chemical engineering, veterinary medicine).
**Languages**:
- Fluent in English and another European language.
**Requirements**:
- Minimum 15 years’ experience in Pharmaceutical or Chemical Production/TS/MS/Pharmaceutical Drug Development / Quality Assurance.
- Thorough understanding of process chemistry and the related production processes.
- Strong working knowledge of quality systems and regulatory requirements across multiple health authorities.
- Fundamental understanding of standard pharmaceutical analytical testing.
- Strong Project management skills, strong communication skills, experience in working with interdisciplinary, multicultural teams.
- Confident in team environment to contribute and challenge the status quo and take a scientific and technical stand when required - can represent scientific and technical information to senior management in a clear and concise manner.
- Expertise in writing and reviewing technical reports
- Excellent problem-solving skills.
- Experienced in technical transfer or project management of production processes at manufacturing scale.
**Other information**:
- Reports to: Director TSMS EEM API
Direct reports: none. Functional, indirect: 0 - 3
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis
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