Lead Operator - Peptide Synthesis

Initial Therapeutics, Inc.; Lebanon (IN); On-site; USD 40,000 - 80,000; Full time

Job summary

An established industry player in healthcare is seeking a Lead Operator for their new API manufacturing facility. This pivotal role involves overseeing the production of active pharmaceutical ingredients while ensuring compliance with safety and quality standards. As part of a dynamic startup team, you will contribute to building processes and systems that support GMP operations. This opportunity promises a collaborative environment where your skills in problem-solving, leadership, and organization will be essential as you help shape the future of the facility. If you're ready to make a significant impact in the pharmaceutical industry, this position is for you.

Qualifications

• 3+ years experience in operations, preferably in a pharmaceutical setting.
• Basic computer skills required; effective communication is essential.

Responsibilities

• Ensure compliance with regulatory requirements during API production.
• Monitor equipment performance and troubleshoot operational issues.
• Participate in safety audits and maintain GMP practices.

Skills

Communication Skills

Problem-Solving

Organizational Skills

Leadership

Flexibility

Education

High School Diploma

Tools

Trackwise

Desktop Software

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.

Organization Overview:

Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) 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 facility to enable a successful startup into GMP manufacturing operations.

Position Brand Description:

The Lead Operator for API manufacturing operations is directly responsible for the production of API molecules used in Lilly medicines. The Lead Operator will be responsible for upholding a safety-first, quality-always mindset in the production of API while running a production process that incorporates a wide range of unit operations.

In the project delivery phase and startup phase of the project (startup expected 2025 to 2027), roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.

Responsibilities:

• Maintain compliance with all regulatory requirements at all times.
• Support the execution of the production plan for the site.
• Carry out daily monitoring testing and cleaning duties as assigned on the above listed systems to ensure equipment and systems are in good operating conditions and they are maintained in accordance with local and corporate regulatory requirements.
• Enter Trackwise events, participate in and lead CAPA investigations.
• Troubleshoot and diagnose process problems and take appropriate actions to minimize deviations or site impact.
• Understand Health, Safety & Environmental-regulated environment and application of Health & Safety/Process Safety standards in order to execute key/critical GMP duties.
• Understand other area processes & their operational hazards and being able to react appropriately.
• Monitor and collect data on equipment use and performance i.e. trying to anticipate potential equipment reliability problems.
• Work with Maintenance and Technical Support to respond appropriately to potential utility supply upsets or equipment failure.
• Contact the appropriate help if there is a problem or an event (spill/deviation/incident) during processing.
• Communicate to other shifts regarding the status of the area operations and details of any issues/problems that have occurred at handover.
• Actively participate in assigned building & area operations such as safety audits, procedure coordination, housekeeping and improvement projects.
• Be trained and qualified on all specified unit operations within the building.
• Identify concerns for informal or formal discussion (shift meetings, safety representative).
• Know and follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification.

Basic Requirements:

• High School Diploma or equivalent.
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
• Completion of Post Offer Exam or Completion of Work Simulation if applicable.
• Ability to effectively communicate (electronically, written and verbal).
• Basic computer skills (desktop software) are required.
• Minimum 3 years previous experience in operations.

Additional Preferences:

• Previous experience in facility/area start-up environments.
• Previous experience in a pharmaceutical manufacturing operation with PSM-regulated/hazardous chemicals.
• Ability to assume leadership and prioritize daily priorities without direct supervision.
• Solid understanding of FDA guidelines and cGMP requirements.
• Strong organizational skills and ability to handle and prioritize multiple requests.
• Knowledge of lean manufacturing principles.
• Flexibility – ability to troubleshoot and triage challenges.
• Ability to understand technical nomenclature and language as well as work with mathematical formulas.
• Manual material handling as appropriate.
• Bend, reach, stretch, climb ladders, and work in tight spaces.
• Stand for long periods.

Additional Information:

• Ability to work rotating 12-hour day or night shifts.
• Ability to work flexible schedules during startup period.
• Ability to work overtime as required.

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.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.