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Buffer Manufacturing Team Lead

Buffer Manufacturing Team Lead

SigmaSaint Louis, MO, US
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Buffer Manufacturing Team Lead

The Buffer Manufacturing Team Lead at our Cherokee site, will play a key role within our GMP Operations Systems & Support team (OSS). The Buffer Manufacturing Team Lead is responsible for overseeing and guiding Manufacturing Scientists and Technicians in the preparation and manufacturing of buffers and solutions. This role requires a proactive approach to identifying and resolving issues while fostering a positive and collaborative work environment. The GMP Packaging Lead will drive compliance with all applicable regulations and maintain a safe and efficient work environment. Job duties include :

  • 2nd shift hours : Monday Friday, 2 : 00pm 10 : 30pm
  • Lead the buffer formulation team in the execution of cGMP buffer manufacturing.
  • Evaluate products according to established protocols, provide technical support to others, and perform operations in support of the group and department.
  • Safely perform operations to meet quality expectations.
  • Maintain required training to perform tasks / assignments.
  • Perform routine processes and unit operations.
  • Clean equipment and working areas during and after operations.
  • Support facility functions (e.g., maintain equipment, prepare reagents, restock supplies, waste disposal).
  • Revise and approve procedures, batch records, and other documentation to ensure compliance with cGMP guidelines.
  • Communicate the status of operations and convey concerns to the supervisor.
  • Provide complete and accurate records consistent with quality guidelines.
  • Ensure all applicable logbooks are completed as required by current procedures.
  • Work cross-functionally with Project Management, Technical Operations, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and Maintenance.
  • Help with MMF review.
  • Participate as needed in quality audits and customer interactions.
  • Improve processes by applying scientific knowledge, experience, and principles, in compliance with change control.
  • Take action to resolve unsafe conditions.
  • Train team members and act as technical consultants.

Physical Attributes :

  • Lift up to 50 pounds
  • Personal protective equipment such as a respirator or chemical protective clothing for extended periods.
  • Who You Are

    Minimum Qualifications :

  • Bachelor's Degree in Chemistry, Biochemistry, Biology, or other scientific discipline
  • 2+ years of experience in GMP manufacturing or operations in a pharmaceutical or biotechnology environment.
  • OR

  • High School Diploma or GED
  • 4+ years' experience in GMP manufacturing in a pharmaceutical or biotechnology environment.
  • Preferred Qualifications :

  • Excellent problem-solving abilities and a proactive approach to identifying and resolving issues, both process and mechanical.
  • Knowledge of process techniques, unit operations, and safe chemical handling methods.
  • Familiarity with regulatory requirements and industry best practices related to GMP manufacturing, including ICH regulatory and Quality standards.
  • Proficient in SAP, Microsoft Office and other software applications.
  • Strong leadership and interpersonal skills, with the ability to motivate and guide a diverse team.
  • Knowledge of Lean Manufacturing principles and continuous improvement methodologies (OpEx).
  • Pay Range for this position : $24-$41 per hour.

    The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

    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.

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    Manufacturing Lead • Saint Louis, MO, US

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