TSMS Senior/Principal Scientist APIEM TIDES

TSMS Senior/Principal Scientist APIEM TIDES

Eli Lilly Benelux

Kinsale, Ireland

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 API EM Senior or Principal Scientist will join the Technical Services/Manufacturing Sciences (TS/MS) team who work within a dynamic external manufacturing environment to provide technical support and scientific expertise across Peptides and Oligonucleotides (TIDES). The Senior/Principal Scientist acts as an SME responsible for providing technical support to achieve the reliable and compliant manufacture of API drug substance at external contract manufacturing groups to predetermined global quality standards. This person interacts daily with a wide variety of people, primarily external partners, process team members and site management.

The candidate will be responsible for technical transfer, process stewardship, process monitoring and will demonstrate a proactive attitude to issue resolution. A strong understanding of manufacturing principles and Lilly systems is required to ensure those same standards are applied to the external contract manufacturers. The incumbent would preferably possess an investigative mindset and be skilled at critical thinking with a preference for collaborative working.

The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards. The position requires working cross-functionally within the site and other functions to deliver on technical objectives.

Key Objectives/Deliverables:

• Provide technical oversight and stewardship for peptide and/or oligonucleotide manufacturing processes.
• Leads resolution of technical issues including those related to control strategy and manufacturing.
• Employ excellent communication skills to manage internal and external relationships, perform effective investigations and disseminate actionable outputs.
• Build and maintain relationships with development partners and central technical organizations.
• Ensure proper characterization of processes and ensure effective documentation and justification of the process description, measures, acceptable ranges, and specifications. Experience with advanced data analytics to ensure that Proven Acceptable Ranges (PAR) and Normal Operating Ranges (NOR) align with process capability.
• Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state through process monitoring. Identify any leading signals of process weakness from yield/quality standpoint and proactively resolve/escalate.
• Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
• Initiate deviation records and ensure on-time closure of open records with appropriate CAPAs and effectiveness checks in place. Demonstrate a structured approach to problem solving and investigation.
• Support regulatory submissions with technical input as required, author and review annual reports to regulatory agencies and maintain awareness of regulatory best practices.
• Influence and implement the network technical agenda and drive continuous improvement with appropriate change controls in place.
• Maintaining peptide/oligonucleotide processes in a state of compliance with US and global regulations.
• Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
• Operate with ‘Team Lilly’ in mind - including coaching and mentoring of peers and other scientists.

Basic Requirements:

• Bachelors in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Chemistry or Biochemistry strongly preferred).
• 3+ years of demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.

Additional Preferences:

• Knowledge and experience with Regulatory requirements.
• Enthusiasm for changes, team spirit and flexibility.
• Ability to influence and communicate to diverse groups on business, or technical issues within the site and function.
• Proficiency in delivering complex tasks and/or tasks that are cross-functional.
• Demonstrated Project Management skills and ability to coordinate complex projects.