Associate/Sr. Associate Manufacturing Scientist - Peptides - Lebanon API

Lilly • Lebanon, IN

75d • $66,000 - $171,600

About The Position

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. Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and systems to enable a successful startup into GMP manufacturing operations.

Requirements

• Bachelors in STEM Discipline (Chemistry preferred) and at least 3 years of experience in cGMP manufacturing, or master's degree and 1 year experience in cGMP manufacturing.

Nice To Haves

• Demonstrated knowledge in peptide synthesis
• Relevant industrial experience in any of the following discipline such as API Manufacturing, TS/MS (Technical Services/ Manufacturing Sciences), Quality Control, Quality Assurance, or Development.
• Familiarity with cGMP manufacturing environment and terminology.
• Excellent analytical, interpersonal, written and oral communication skills.
• Ability to work on own initiatives and as part of a Process Team consisting of a diverse group of management, production, science and engineering professionals.
• Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented.
• Guidance/mentoring of others through processes.
• Flexibility to meet business needs.

Responsibilities

• Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment.
• Execute technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity.
• Provide technical support for preparation of relevant technical documents, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs (Process Flow Documents), Validation Master Plans, Operational and Process Control Strategy etc.
• Develop and monitor established metrics in real-time to assess process variability and capability.
• Understand, justify, and document the state of validation (process and cleaning) with data that evaluate the capability of the manufacturing process to meet its stated purpose.
• Ensure that an accurate instruction set (batch production records & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
• Ensure that experiments are well designed with clear objectives.
• Investigate deviations using appropriate tools to ensure quality of the product.

Benefits

• Eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees