Senior Aseptic Manufacturing Lead - Sterile Pharma

Harba Solutions Inc.; Fishers (IN); On-site; USD 120,000 - 135,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A pharmaceutical manufacturing company in Fishers, IN, seeks an experienced Production Manager to lead sterile drug product manufacturing, ensuring compliance and efficient processes. The ideal candidate will have a Bachelor’s degree and at least 7 years in pharmaceutical manufacturing with significant leadership experience. Key responsibilities include managing the manufacturing team, supporting audits, and enhancing production initiatives. This position offers competitive benefits and a full-time role.

Qualifications

• Bachelor’s degree in Chemistry, Engineering, Life Sciences, or a related field.
• Minimum of 7 years’ experience in pharmaceutical manufacturing, including 5 years in leadership roles.
• Strong expertise in sterile/aseptic manufacturing of parenteral products.
• In-depth understanding of regulatory standards and validation requirements in highly regulated industries.
• Demonstrated success in leading multi-disciplinary teams.
• Effective project management, prioritization, and communication skills.
• Ability to lead in dynamic, high-pressure environments.
• Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word, SharePoint), MS Project, and Visio.
• Experience in radiation safety or working with radioactive materials preferred.
• Lean/Six Sigma certification is a plus.
• Willingness to travel up to 5% of the time.

Responsibilities

• Provide day-to-day leadership and direction to the manufacturing team.
• Ensure safe, compliant, and efficient execution of aseptic manufacturing processes.
• Serve as a subject matter expert on aseptic technique, regulatory compliance, and sterile production.
• Partner closely with Quality, Engineering, Maintenance, and other cross-functional departments.
• Support site readiness for internal and external audits and regulatory inspections.
• Ensure production schedules are met to support commercial demand.
• Support the implementation of new product initiatives and capital improvement projects.
• Maintain adherence to all cGMP, safety, and radiation safety requirements.
• Lead and develop direct reports; foster a culture of accountability and continuous improvement.
• Utilize lean manufacturing and/or Six Sigma tools to drive operational efficiency.

Job description

A pharmaceutical manufacturing company in Fishers, IN, seeks an experienced Production Manager to lead sterile drug product manufacturing, ensuring compliance and efficient processes. The ideal candidate will have a Bachelor’s degree and at least 7 years in pharmaceutical manufacturing with significant leadership experience. Key responsibilities include managing the manufacturing team, supporting audits, and enhancing production initiatives. This position offers competitive benefits and a full-time role.