Elanco Hiring for Manager External Innovation Analytics (m/w/d) at Monheim, Bayern Full Time

Interested in joining a cause-driven, customer focused company dedicated to positively impacting the health of animals, people and the planet? Search our job listings below.

JOB TITLE: Manager External Innovation Analytical in Small Molecules Technical Development / API Team

(m/f/d) temporary position limited to 1 y (maternity cover)

YOUR TASKS AND RESPONSIBILITIES

• Global analytical development and strategic CMC direction of assigned APIs during their development phase
• Identification, evaluation and selection of external cooperation partners including placement of orders
• Supervision of cmc work packages at cooperation partners regarding the development of analytical methods, chemical characterization, control strategies, and specifications for Active Pharmaceutical Ingredients (APIs), impurities, starting materials and intermediates; performance evaluation of external partners
• Preparation of registration relevant documents for worldwide market authorization (including answers to authority requests) ensuring compliance with all relevant external regulations related to CMC-submissions (e.g. VICH, FDA, EMA, EPA)
• Responsibility for timely delivery of project compound quantities within global development programs of Elanco Animal Health in close collaboration with procurement, formulation development and other functions
• Responsibility for due diligences as Small Molecule Technical Development (SMTD) representative (m/f) for API and support of license negotiation regarding the chemistry, manufacturing and control (CMC) part
• Team member (m/f) and CMC lead (m/f) in global project teams

WHO YOU ARE

• Master degree and PhD in a scientific discipline (e.g. chemistry, pharmacy) with strong background in analytics (both quantification and spectroscopy); normally followed by postdoctoral fellowship at an internationally recognized institution
• Specialist knowledge of analytical development with a curiosity and willingness to develop in new areas
• Preferably several years experience of managing a laboratory in an industrial company
• Professional experience in veterinary/pharmaceutical/agricultural research, development, manufacturing, control and assessment of APIs and products
• Experience of submission of CMC-related /analytical topics along with GLP, GMP and other quality systems
• Organizational and leadership skills with the ability to lead and inspire a matrix team to deliver best science work
• High ability to solve problems and to structure and simplify complex tasks
• Very good communication and presentation skills; fluent in English and German (both written and spoken); ability to translate complex scientific results into clear messages

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status