Sr. Scientist Peptides - Person in Plant

Eli Lilly and; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

A leading global healthcare company is seeking a TSMS Sr. Scientist for Peptides in the United States. This role involves providing technical leadership for the manufacturing processes, ensuring compliance with regulations, and optimizing operations in collaboration with contract manufacturers. Ideal candidates will have a Bachelor’s degree in Chemistry or Biochemistry and over 5 years of experience in GMP pharmaceutical environments.

Qualifications

• 5+ years of experience with GMP pharmaceutical manufacturing and regulatory expectations.
• Demonstrated ability to function as a technical leader in a team.
• Ability to manage and prioritize competing priorities and communicate effectively.

Responsibilities

• Develop and sustain process knowledge to ensure execution at the Contract Manufacturer.
• Lead resolution of technical issues including those related to control strategy and manufacturing.
• Influence and implement the network technical agenda and drive continuous improvement.

Skills

Technical leadership

Process optimization

Communication skills

Regulatory knowledge

Education

Bachelor of Science in Chemistry or Biochemistry

Job description

Overview

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 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 are seeking individuals determined to make life better for people around the world.

The position of TSMS Sr. Scientist Peptides Person in Plant - APIEM reports to the TSMS Director – Peptides API EM and provides technical leadership and expertise with API EM contract manufacturer personnel to ensure reliable supply and commercialization of medicines with safety first and quality always.

• Developing and sustaining process knowledge to ensure 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 interacting 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 standards are applied to external contract manufacturers.

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

Responsibilities

• Build and Sustain Process Team Relationships

• Utilize past experiences with unit operation control to provide insight and feedback to 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 processes are compliant, capable, in control, and maintained in a validated or qualified state.
• Enable development and maintenance of process knowledge infrastructure such as validated process monitoring spreadsheets.
• Review and track key process parameters (e.g., CPPs, rOPPs, IPC).

• Provide Process Support

• Lead resolution of technical issues including those related to control strategy and manufacturing.
• Ensure proper characterization of processes and products and documentation of process descriptions, measures, acceptable ranges, and specifications with justifications.
• Understand, justify and document the state of validation with data assessing process capability.
• Identify systemic issues affecting production and reliable CM supply.
• 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.
• Maintain peptide processes in compliance with US and global regulations.
• Understand scientific principles for manufacturing intermediates and drug substances, including chemistry/equipment interactions.
• Support development and technical analysis for ongoing improvement activities.
• Identify cost reduction opportunities, capacities, and bottlenecks.
• Prioritize opportunities aligned with business objectives.
• Optimize unit operation cycle time, loading, and yield.

Qualifications

• Basic Requirements:

• Bachelor of Science in Chemistry or Biochemistry
• 5+ years of experience with GMP pharmaceutical manufacturing and regulatory expectations
• Demonstrated ability to function as a technical leader in a team
• Ability to manage and prioritize competing priorities and communicate effectively

Additional Preferences

• Root cause analysis and systematic problem solving
• Regulatory knowledge
• Data management practices in manufacturing
• Flexibility and team-oriented attitude
• Ability to influence and communicate with diverse groups
• Project management skills for coordinating complex tasks

Other Information

• Typical schedule is Monday–Friday, 8 hours/day; teleconferences may occur outside hours due to time zones of contract manufacturers. Some off-shift work may be required for 24/7 support.
• Tasks may require entering manufacturing and laboratory areas with appropriate PPE.
• Some travel may be required.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If accommodation is required to submit a resume, please complete the accommodation request form at the following URL: https://careers.lilly.com/us/en/workplace-accommodation. This is for accommodation requests as part of the application process.

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. #WeAreLilly