Lilly External Manufacturing Advisor - Monoclonal Antibodies in KINSALE, Ireland
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Lilly, a leading innovation-driven corporation is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly makes life better – through medicines and information – for some of the world’s most urgent medical needs. Founded over 145 years ago, the company has sustained a culture that values excellence, integrity, and respect for people. This has resulted in Lilly frequently being ranked as one of the best companies in the world at which to work. Lilly knows its business has prospered because of its employees – people with a talent for innovation and a passion for making a difference by finding treatments for the most stubborn diseases; people whose talent is matched by their generosity, and people with strong values and a determination to prevail, regardless of the challenges. Join our team – and make a difference in improving health for people all over the world!
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.
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.
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
- Occasional travel required 5 – 15%.
- Indianapolis, IN or Kinsale, Ireland
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