Manufacturing Manager - BioServices

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.

Responsibilities:

This position is responsible for providing support to their respective process team per Manufacturing Standard for Operational Excellence (MSOE) 602, specifically focusing on safety, quality and manufacturing performance. Provide daily supervision of an area within manufacturing; responsible for production timelines and department goals. This includes process planning activities, setting schedules, coordinating interactions and services from other groups, internal and external, to the manufacturing organization, and assigning daily work tasks. Additional responsibilities will be hiring, development, coaching/leading, and training of manufacturing operators in the assigned area.

Primary Responsibilities

• Ensure production activities comply with cGMP guidelines.  Follow all documentation and standard operating procedures.  Set priorities, process execution, work assignments, and reprioritize as required.
• Responsible for providing support to their respective process team, per Manufacturing Standard for Operational Excellence (MSOE) 602.
• Responsible for cGMP compliance, ensuring that all production equipment is properly validated, and procedures are maintained within validated state
• Author and revise standard operating procedures and batch records.  Review technical reports.  Conduct deviation investigations and write process deviation reports
• Ensure that all production equipment is properly maintained, production areas are inspection ready, and production processes meet quality standards
• Train personnel in manufacturing process/operations following standard operating procedures and cGMP guidelines.
• Measure and appraise operator performance against job duties, objectives, and goals. Provide accurate and timely feedback. Recommend merit increases, promotions, hires, and terminations.
• Serve as area advocate in cross functional meetings.  Champion company policies to area staff.
• Contribute and adhere to safety, environment, quality and EEO/AA standards of the Corporation
• Communicate safely and maintenance problems., status of operations, and employee-related issues in a timely manner to management.

Basic Qualifications:

• Bachelor's degree in Biology, Chemistry, or related discipline, or relevant work experience.
• BS with minimum of 2 years of relevant experience or HS diploma/GED with a minimum of 3 years of relevant work experience.

Additional Skills/Preferences:

• Must be able to make critical decisions 7 days/week.  Must be able to effectively (clearly and accurately) communicate decisions to staff and upper management.
• Must be able to mentor/coach staff as well as lead staff with a high level of honesty and integrity
• Must have a thorough theoretical understanding and technical proficiency of operations within an area
• Must be able to apply technical and operational experience to solve complex problems.
• Must be able to write effectively as demonstrated through authorship of batch records, standard operating procedures, and non-conformance event investigations
• Must exhibit a team first attitude.
• Must possess excellent communication, interpersonal, and written skills.
• Must meet the physical requirements of the job; must have the ability to:
  • Lift a minimum of 50 lbs.
  • Bend, reach, stretch, climb ladders, and work in tight spaces.
  • Stand for long periods.
  • Wear appropriate clean room attire.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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