Pharmaceutical Manufacturing Manager; 3rd Shift

Pharmaceutical Manufacturing Manager (3rd Shift)

Bloomington, Indiana, United States

Simtra Bio Pharma Solutions is a world‑class contract development and manufacturing organization that partners with pharmaceutical and biotech companies to bring sterile injectable products to market. With facilities in Bloomington, Indiana and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre‑filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder‑filled vials, and sterile crystallization.

The Manufacturing Manager is responsible for all production activities on a shift, supporting multiple filling lines that manufacture injectable drug products. The manager leads a team of manufacturing supervisors and reports directly to the Senior Manufacturing Manager (Building Manager). The role includes overseeing staff, ensuring compliance with cGMP regulations, facilitating continuous improvement, managing the shift schedule, and serving as the primary contact for manufacturing‑related communications.

• Lead a team of manufacturing supervisors to compliantly meet the production schedule in controlled environments.
• Partner with peers in other manufacturing buildings and on other shifts to ensure the site schedule is maintained.
• Interview, hire, coach, and develop staff; provide timely and accurate feedback recognizing good or poor performance.
• Develop, deploy, and properly manage processes to consistently run the business and improve the business.
• Partner with quality and technical services leaders to author, review, and/or approve investigations and drive timely closure to meet client delivery dates.
• Approve SOPs, validations, and protocols in a timely manner.
• Partner with client teams to support client projects and client audits.
• Provide technical expertise and resources, coordinating with Quality, Program Management, Engineering, Maintenance, and Technical Services.
• Ensure the organization’s budget is met and maintain expenses within the plan.
• Regularly interact with senior management and client representatives on matters concerning several functional areas, divisions, and/or customers.
• Take personal responsibility to develop, deploy, and properly manage a culture of safety and working conditions in accordance with environmental, health, and safety SOPs and policies.
• Lead in a manner that inspires trust of subordinates, peers, and superiors, acting as a role model of respect and integrity.
• Practice lean leadership, instill a culture of “go and see,” and adopt best practices to influence others.

• Bachelor’s degree strongly preferred, with emphasis on a scientific or engineering discipline.
• Minimum five years’ experience in all aspects of the aseptic pharmaceutical manufacturing process.
• Knowledge of GMPs and worldwide regulatory agency guidelines.
• Minimum three years in a leadership role, preferably in parenteral manufacturing.
• Lean Manufacturing experience required (e.g., value‑stream mapping, leading kaizen events, and teaching people to think).
• Computer proficiency in Microsoft Word, Excel, and Outlook; experience with enterprise software such as JDE, BPLM, MAXIMO, TRACKWISE, etc.

• Ability to stand for extended periods of time.
• Physical coordination/flexibility to allow gowning for clean‑room environments.
• Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat‑resistant wear, and hearing protection.
• Dexterity and physical condition to perform some level of repetitive motion tasks.
• Ability to wear respirator when required.
• Duties may require overtime work, including nights and weekends.
• Use of hands and fingers to manipulate office equipment is required.
• Must be able to gown qualify for Grade A/B areas (filling).
• Position may require sitting for long hours.

• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
  • Spouse Life Insurance
  • Child Life Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
  • Paid Holidays
  • Paid Time Off
  • Paid Parental Leave and more
• Adoption Reimbursement Program
• Ed…