API EM TS/MS Mfg. Scientist – Peptides

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 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.

The position of Principal Technical Services Rep - APIEM reports to the TSMS Director – Peptides API EM and provides technical leadership and expertise in conjunction with API EM contract manufacturer personnel in the reliable supply and commercialization of medicines with safety first and quality always by: 

• Developing and sustaining process knowledge in order to ensure the execution of the appropriate product, process, and operational control strategy at the Contract Manufacturer (CM).
• Direct and Indirect interaction with CM personnel to ensure reliable supply via the CM execution of the operational control strategy.
• Participation with internal or CM resources in technical transfer, process validation, and process data monitoring.
• Adherence to the expectations of the Lilly Red Book when carrying out interactions with API EM’s CMs.

Key Objectives/Deliverables:

The candidate will be responsible for process monitoring, response to issues, and improvements where necessary. A strong understanding of manufacturing principles and Lilly systems is required to ensure those same standards are applied to the external contract manufacturers.

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.

Build and Sustain Process Team Relationships

• Utilize past experiences with unit operation control to provide insight and feedback to members of the Lilly / CM Joint Process Team (JPT).
• Employ excellent communication skills to manage internal and external relationships.
• Build and maintain relationships with development and central technical organizations.
• Operate with ‘Team Lilly’ in mind - including coaching and mentoring of peers and other scientists.

Develop and Sustain Process Knowledge

• Provide technical oversight and stewardship for peptide manufacturing processes.
• Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state.
• Enable the development and maintenance of process knowledge infrastructure such as validated process monitoring spreadsheets
• Review and track key process parameters (i.e. CPP’s, rOPP’s, IPC, etc.)

Provide Process Support

• Leads resolution of technical issues including those related to control strategy and manufacturing.
• 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).
• Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
• Identify systemic issues affecting production and reliable supply from CMs
• Lead or participate in root cause analysis and CAPA development

Process Optimization & Continuous Improvement

• Influence and implement the network technical agenda and drive continuous improvement.
• Maintaining peptide 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.
• Support development and technical analysis for on-going continuous improvement activities.
• Review and identify cost reduction opportunities, as well as process capacities and bottlenecks.
• Assist in prioritization of opportunities with respect to overall business objectives.
• Perform and promote optimization of unit operation cycle time, loading, and yield performance.

Basic Requirements:

• Bachelor of Science in Chemistry or Biochemistry
• 5+ years of demonstrated experience and proficiency with GMP pharmaceutical manufacturing and working knowledge of regulatory expectations.
• Demonstrated ability to function in a team environment as a technical leader and as a member of teams.

• Demonstrated ability to manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audiences.

Additional Preferences:

• Successful application of root cause analysis and systematic problem solving
• Knowledge and experience with Regulatory requirements
• Knowledge of data management practices across manufacturing
• 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

Other Information:

• The normal schedule for this position is Monday-Friday, 8 hours/day.  However, teleconferences may routinely occur outside of these hours due to the time zones of contract manufacturers. Some off-shift work (night/weekend) may be required to support 24/7 operations

• Tasks require entering manufacturing and laboratory areas and will require wearing appropriate PPE.
• Some travel (<25%) is required. International travel may be required to support process start-ups, troubleshooting, and commercial manufacturing.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly 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.

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Experience Level

Mid Level