Formulation Group Leader Weekend PM

The Formulation Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor. They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Formulation Operators who perform in the manufacturing areas. The Formulation Group Leader provides decision‑making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures.

This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments. The Formulation Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.

• Prepare media and buffer solutions
• Operate Clean-in-Place (CIP) and Steam-in-Place (SIP) systems
• Operate general production equipment (such as pH and conductivity meters, autoclaves, portable mixers, scales and balances, etc.)
• Monitor and record critical process parameters
• Complete all relevant paperwork following GDP/GMP guidelines
• Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion
• Perform sampling using aseptic techniques
• Participate on Continuous Improvement Teams
• Train and mentor other team members
• Write, revise and review pertinent documentation as appropriate
• Troubleshoot process problems and respond to process alarms
• Assist with process/equipment validation and data analysis
• Work with other groups such as maintenance/metrology and calibration to ensure preventative maintenance completion
• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime will be required

Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions. Must be able to occasionally (1‑33% of the time) work in a confined/clustered work space.

• Ability to work independently
• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of aseptic manufacturing practices
• Knowledge of standard operating procedures, specifications, and job‑specific training materials/Subject Matter Expert
• Experience operating multiple types of equipment related to the manufacturing operations as well as hand‑operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices

• Occasional (1‑33%):
  Sitting, climbing stairs and ladders, balancing, kneeling, operating controls
• Frequent (34‑66%):
  Standing, walking, reaching forward and overhead, stooping, crouching
• Pushing and pulling up to 110 lbs
• Lifting and carrying up to 70 lbs
• Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping

• High school diploma or GED required
• 6 months of previous Pharmaceutical or Manufacturing experience preferred
• Final candidates for Formulation Group Leader will be required to pass a post‑offer/pre‑employment job placement examination which will test the physical capabilities to perform the essential functions of the job
• Must be able to understand, speak, read and write English in order to comply with necessary SOPs, job‑specific training materials, GMPs, and other manuals

• 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

Simtra is 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.