Elanco chemistry Job Vacancy 2021- Apply Now:
Job Title: Senior Director-Head Pharmaceutical Development Unit III
Job Location: DE - BAH (monheim)
Your Task & 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 formulation including dissolution method Development and 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 need to enable the conduct of proof of concept and toxicological studies.
- Develop and pharmaceutically assess high-quality, convenient dosage from products for NCE active ingredients and line extensions as well as new drug delivery system of late phase development and marketed drug substance in line with clinical needs and marketing requirement.
- Develop and pharmaceutically assess safe, robust and economic processes for respective drug product formulations.
- Ensure high quality technical documentation and compliance with all relevant external regulation related to CMC- submission and GMP-standards(e.g., VICH, FDA, EMA, EPA....) to obtain timely regulatory approval during development as well as for marketing authorizations.
- Manage personal 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 sprit and align the PDU as a process oriented team with strong focus on delivery.
- Provide leadership, support and mentoring to the expert analytical or formulation members of the PDU and support experts to fulfil the role of CMC lead and core project team representative.
WHO YOU ARE
- Master degree in a scientific discipline ( chemistry, biology, biochemistry, pharmacy or veterinary medicine)
- PhD, normally followed by postdoc period at an internationally recognized institution
- Specially knowledge of one area of formulation technology or analytical development with a curiosity and willingness to develop in new areas.
- Several years experienced of managing a laboratory in an industrial company.
- Experienced in all aspects of formulation development, analytical development, technology and production.
- Professional experience in pharmaceutical/agriculture research, development, manufacturing, control and assessment of products.
- Organizational and leadership skill with the ability to lead and inspire a lab team to deliver best science research work.
- High ability to solve problems and to structure and simple 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 submission of part II-related analytical topics and GLP, GMP as well as other quality system.
"Genius is 1 Percent inspiration
& 99 percent perspiration"
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