cGMP Associate Production Scientist

Work Location: St. Louis, Missouri
Shift:
Department: LS-SC-POKMB1 Cherokee STL Organics 1
Recruiter: Erin Wilson

This information is for internals only. Please do not share outside of the organization.

Your Role

At MilliporeSigma, as the cGMP Associate Production Scientist - Night Shift, at our location 3300 South Second/ Cherokee site, is responsible for the manufacturing of active biopharmaceutical ingredients (APIs) Chemicals and bulk pharmaceuticals regulated by the Food and Drug Administration (FDA). The Associate Scientist is responsible for following manufacturing protocols, consistent with and established according to current Good Manufacturing Practices (cGMP) and ensuring the accuracy of documentation. Job duties include:

• Production Shift work includes: 12-hour shifts, night schedules with competitive shift differential, and/or rotating shifts working during various days of the week.

12-hour night shift 6pm-6:30am with Two-Week Rotation

Week 1 (Monday/Tuesday/Friday/Saturday and Week 2 (Sunday, Wednesday/ Thursday)

• Perform production operations and responsibilities, potentially in the presence of the Customer, and communicate production status to Manufacturing Supervision.
• Provide technical leadership during the manufacturing process.
• Acquire equipment and ensure cleaning protocols are performed and logged.
• Ensure production areas, chemicals, and equipment are staged and ready for production operations.
• Perform necessary analytical tests and evaluate results during the production operation.
• Advise chemical processors for critical, in-process decisions based on analytical results.
• Write and revise Master Manufacturing Formulas.
• Prepare and review Operating Procedures to ensure compliance with FDA and cGMP guidelines.

Physical Attributes

• Lift and carry up to 50 pounds while wearing personal protective equipment, including respirators, for an extended time.
• Ability to perform tasks while wearing personal protective equipment such as respirator or chemical protective clothing for extended periods.

Who you are:

Minimum Qualifications:

• Bachelor's Degree in a scientific discipline (e.g., Chemistry, Biochemistry, Chemical Engineering, etc.)

OR

• Associate Degree with 2+ years GMP production experience

Preferred Qualifications:

• 1+ year GMP experience.
• Detail oriented with excellent organizational, written, and verbal communication skills.
• Logical approach to problem solving.
• Experience with customer interaction.
• Knowledge of Process Improvement methodology (e.g., PDSA, Lean Manufacturing, and/or Six Sigma).

RSREMD

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.