Elanco Chemistry Job Opening 2021 – Candidates Apply Online
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Job Title: Senior Director – Head Pharmaceutical Development Unit III
Location: DE – BAH (Monheim)
WHO YOU ARE
- Master degree in a scientific discipline (chemistry, biology, biochemistry, pharmacy or veterinary medicine)
- Ph.D., normally followed by a postdoc period at an internationally recognized institution
The specialist knowledge of one area of formulation technology or analytical development with a curiosity and willingness to develop in new areas
- Several years experience of managing a laboratory in an industrial company
- Experience in all aspects of formulation development, analytical development, technology, and production
- Professional experience in pharmaceutical/agricultural research, development, manufacturing, control, and assessment of products
- Organizational and leadership skills with the ability to lead and inspire a lab team to deliver the best science research work
- High ability to solve problems and to structure and simplify complex tasks
- Strong cross-functional communication skills, excellent communication, presentation and writing abilities in English and German and the ability to translate complex scientific results into clear messages
- Experience in the submission of part II-related analytical topics and GLP, GMP as well as other quality systems.
YOUR TASKS AND RESPONSIBILITIES
- Global strategic orientation and management of Pharmaceutical Formulation and Analytical Development of small molecule dosage forms and life cycle management projects across Elanco Animal health.
- Assess feasibility of respective drug product formulation approaches to overcome technically challenging compound properties (e.g. solubility issues, stability and inadequate PK profile).
- Responsibility for Analytical Development and Quality Control for drug formulations including dissolution method development and other special analytical services. Define globally applicable analytical methods and quality standards for all drug product-related activities
- Provide prompt and high-quality formulation and analytical support as needed to enable the conduct of proof of concept and toxicological studies (service formulations for early development)
- Develop and pharmaceutically assess high-quality, convenient dosage form products for NCE active ingredients and line extensions as well as new drug delivery systems of late phase development and marketed drug substances in line with clinical needs and marketing requirements.
- Develop and pharmaceutically assess safe, robust and economic processes for respective drug product formulations.
- Ensure high-quality technical documentation/dossiers and compliance with all relevant external regulations related to CMC submissions and GMP standards (e.g. VICH, FDA, EMA, EPA …) to obtain timely regulatory approval during development as well as for marketing authorizations.
- Manage personnel, budget resources, and talent management of the PDU. Monitor the performance of the unit according to the set targets, providing timely feedback and assuring the necessary people development actions.
- Develop and foster a team spirit and align the PDU as a process-orientated team with a strong focus on delivery.
- Provide leadership, support, and mentoring to the expert analytical or formulation members of the PDU and support experts to fulfill the role of CMC lead and core project team representative
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