Pharmaceutical Manufacturing Manager, (3rd Shift)

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 90,000 - 115,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with Company Match

Education Assistance Program

Job summary

Simtra BioPharma Solutions is hiring a Pharmaceutical Manufacturing Manager for the 3rd Shift in Bloomington, Indiana. In this role, you will lead a team of supervisors to ensure that all production activities comply with regulations and meet the production schedule. The ideal candidate will have a Bachelor’s degree and a minimum of five years’ experience in aseptic manufacturing. Strong leadership skills and knowledge of GMPs are essential, along with proficiency in Microsoft Office and other enterprise software. A range of benefits including medical coverage, 401(k), and education assistance are offered.

Qualifications

• Minimum five years’ experience in all aspects of the aseptic pharmaceutical manufacturing process.
• Minimum three years in a leadership role, preferably in parenteral manufacturing.
• Knowledge of GMPs and worldwide regulatory agency guidelines.

Responsibilities

• Lead a team of manufacturing supervisors to compliantly meet the production schedule.
• Ensure compliance with cGMP regulations.
• Coach and develop staff and provide feedback.

Skills

Aseptic manufacturing experience

Leadership skills

GMP knowledge

Lean manufacturing experience

Computer proficiency in Microsoft Office

Education

Bachelor’s degree in a scientific or engineering discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

JDE

BPLM

MAXIMO

TRACKWISE

Job description

Pharmaceutical Manufacturing Manager (3rd Shift)

Bloomington, Indiana, United States

Simtra BioPharma 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.

Responsibilities

• 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.

Qualifications

• 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.

Physical / Safety Requirements

• 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.

In Return, You’ll Be Eligible For

• 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
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• Additional Benefits
  • Short- and Long-Term Disability Insurance
• Voluntary Insurance Benefits
  • Vision Coverage
  • Accident
  • Critical Illness
  • Hospital Indemnity Insurance
  • Identity Theft Protection
  • Legal and more
• Onsite Campus Amenities
  • Workout Facility
  • Cafeteria
  • Credit Union

Current benefit offerings are in effect through 12/31/26.

Disclaimer

This job description is intended to provide the minimum knowledge, skills, and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity Statement

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.