Description:
Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The External Manufacturing Advisor - Monoclonal Antibodies will provide technical and scientific expertise within a dynamic external manufacturing environment. The role is focused on ensuring delivery of commercialization efforts including technical transfers, process validations, and process optimization for the mAb portfolio. This position requires comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real-world solutions. In addition, experience and capability across upstream and downstream monoclonal processes are necessary.
Key Objectives/Deliverables
- Provide technical oversight and stewardship for mAb manufacturing processes (upstream and downstream).
- Leads resolution of technical issues including those related to control strategy and manufacturing.
- Employ excellent communication skills to manage internal and external relationships.
- Build and maintain relationships with development and central technical organizations.
- Ensure proper characterization of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, and specifications (and the justification of these measures, acceptable ranges, and specifications).
- Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state.
- Optimize and execute site control strategies.
- Successfully deliver on strategic initiatives.
- Influence and implement the network technical agenda and drive continuous improvement.
- Maintaining processes in a state of compliance with US and global regulations
- Understanding the scientific principles required for manufacturing drug substances, including the interaction of chemistry and equipment.
- Understand the biochemistry and stability of biomolecules.
- Operate with ‘Team Lilly’ in mind - including coaching and mentoring of peers and other scientists.
Basic Requirements
- Master’s Degree or higher in scientific disciplines of Biotechnology, Biochemistry, Chemistry, Chemical Engineering, Pharmacology, or related fields
- 5+ years of demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations