Manufacturing Scientist - Lebanon API Manufacturing

Initial Therapeutics, Inc.; Lebanon (IN); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Manufacturing Scientist to join their innovative team in Lebanon, IN. This role offers a unique opportunity to contribute to the startup of a state-of-the-art manufacturing facility dedicated to producing API molecules. As part of the Technical Services/Manufacturing Science team, you will be responsible for executing technical projects aimed at optimizing manufacturing processes and ensuring compliance with industry standards. If you are passionate about improving healthcare and have a strong background in cGMP manufacturing, this position is perfect for you. Join a forward-thinking company where your skills will directly impact the production of life-changing medicines.

Qualifications

• 3+ years of experience in cGMP manufacturing or 1 year with a Master's.
• Knowledge in small molecule, peptide, or oligonucleotide API Manufacturing.

Responsibilities

• Execute technical projects to improve process control and productivity.
• Provide technical support for preparation of relevant documents.
• Analyze data and ensure appropriate documentation.

Skills

Analytical skills

Interpersonal skills

Written communication

Oral communication

Creativity

Education

Bachelor's in STEM Discipline (Chemistry preferred)

Master's Degree

Tools

cGMP manufacturing processes

Technical documentation

Job description

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.

Organization Overview:

The Manufacturing Scientist is part of the TSMS (Technical Services/Manufacturing Science) team that provides the technical support required to achieve reliable and compliant manufacturing of API molecules. This role will be part of the Manufacturing Process Team for its respective area, providing daily oversight to ensure safe and reliable supply of medicines. The Manufacturing Scientist executes technical projects (experimental, modeling and/or production data analysis) to improve and optimize process control, yield, purity, and/or productivity. In addition, the manufacturing scientist should be capable of setting up and executing a variety of experiments at laboratory scale and conducting research on manufactured product for process improvements and troubleshooting in the technical services and manufacturing sciences laboratory.

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), VMPs, 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 (tickets & 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.
• Ability to analyze data and ensure appropriate documentation.
• Write technical reports and documents.

Basic 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.

Additional Preferences:

• Demonstrated basic knowledge in small molecule, peptide, or oligonucleotide API Manufacturing.
• Relevant industrial experience in any of the following disciplines 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 initiative 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.