Detailansicht des Stellenangebots

Stellenbeschreibung

Job Description

Lab Manager Formulation Development SMTD, 100% fixed duration (1 year) (m/f/d)

Elanco Monheim, North Rhine-Westphalia, Germany On-site

The role:

This position is responsible for formulation development and related activities associated with the development of animal health products at Elanco SMTD (Small Molecule Technical Development). Responsibilities of this role include formulation development activities of the entire drug product development life cycle such as development of prototype formulations, study material supply (GMP and non-GMP), coordination of formulation development activities with internal and external partners and the management of internal lab unit(s). The person in this role will apply scientific/technical expertise to address complex formulation development tasks within product development and to author documents supporting submissions in coordination with regulatory affairs personnel. This position is expected to incorporate Quality by Design (QbD) principles throughout the development process in alignment with commercial. The person in this role supports identification and selection of Contract Research/Development/Manufacturing Organizations (CRO/CDO/CMO) and provides technical oversight of CRO/CDO/CMO development work.

Functions, Duties, Tasks:

• Plan, execute and coordinate daily and weekly work schedule in the formulation lab. Design, review and make recommended changes to scientific protocols and procedures.
• Perform data analysis and propose design of next experiment.
• Present results at team, project or unit meetings.
• Perform troubleshooting activities.
• Write reports and may write external publications. Prepare SOPs/working procedures. Support preparation of registration documents.
• Contribute to evaluation of new scientific technologies and procedures.
• Collaborate with other associates and scientists to facilitate knowledge exchange. Train and coach peers. May supervise local team members.
• Maintain infrastructure of laboratory and an organized, clean and safe working environment. Schedule and perform maintenance of instruments/equipment (if needed). Evaluate new laboratory equipment.
• Oversee the work of external partners, evaluate results and define the next steps
• Work according to external and internal guidelines (e.g. SOP’s, GxP, HSE, and AW).

Minimum Qualification (education, experience and/or training, required certifications):

• PhD in pharmaceutical science
• Ideally, proven experience in pharmaceutical industry (3 years)
• Experience in formulation development of oral dosage forms and process scale-up
• Ideally, proven track record of projects including technologies such as granulation, tableting, coating & extrusion
• Understanding and strong working knowledge of GMP and industry/global regulatory guidelines, such as VICH and ICH. 
• Ability to work effectively and flexibly within and across Elanco SMTD and R&D teams, manufacturing, and external collaborators.
• Innovative mindset
• Language Requirements: English, German

Other Information:

• Travel requirement approximately 5-10%