Supervisor, cGMP Manufacturing
Millipore Corporation

St. Louis, Missouri

Posted in Science and Research
about 1 month ago


This job has expired.

Job Info


Your Role:

The Supervisor of cGMP Manufacturing position supports our cGMP Manufacturing in the area of Biologic Active Pharmaceutical Ingredients, including Antibody Drug Conjugates (ADCs). ADCs are an exciting class of biopharmaceutical drugs that utilize both the targeting effects of monoclonal antibodies and the potent activity of cytotoxic drugs, hence allowing discrimination between the cancer cells and healthy normal cells.

In this role, you'll be responsible for leading a team of production scientists and operators in the scale-up, technology transfer, and execution of cGMP manufacturing. This position will be expected to develop employees' knowledge and skills to improve performance and expand abilities as well as to coordinate the group's efforts to assist meeting the departmental, company, and customer's objectives.

The cGMP Manufacturing Supervisor is responsible for the manufacturing of processing aids, excipients, and Active Pharmaceutical Ingredients (API's) regulated by the Food and Drug Administration and other regulatory bodies. Adherence to protocols consistent with, and established according to, current Good Manufacturing Practices, is essential. In this role, you'll be interacting cross-functionally with Project Management, Technical Operations, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and Maintenance. This role requires significant interaction with our customers' project management, technical and quality teams.

Customer interaction adds an additional element to this position. The customer judges our Company based on interactions with our employees, deciding if continual business opportunities will be offered to MilliporeSigma. This element adds an additional challenge to the employee in this position to represent MilliporeSigma with the highest level of professionalism and responsibility. Experience with this level of customer interaction is desired.

To succeed in this role, you should have supervisory and manufacturing experience, with a cGMP API manufacturing focus. We're looking for a strong leader with a proven track record leading personnel in a cGMP manufacturing department. The ideal candidate will have an established history for selecting, training, developing, motivating, and evaluation of employees.

You will be expected to lead a manufacturing team responsible for technical transfer of new pharmaceutical projects, including high potent APIs, as well as manufacturing of existing products under cGMP regulations (ICH Q7).

You will supervise employees to accomplish all departmental goals and objectives in a safe manner and in compliance with all applicable federal, state, and company regulations (OSHA, EPA, FDA, EMA etc.). The position will be looking for skills within quality, safety, budget, operational excellence, and customer service.

You will be expected to exhibit strong communication proficiencies throughout the reporting structure, ensuring information is passed on to employees in a timely fashion as well as communicate feedback to management.

Responsible for the management of capital for equipment and facility improvements, including balancing the departmental budget. Support Department efforts toward Process Improvement and company goals. Revise and approve procedures, batch records, and other documentation to ensure compliance with cGMP guidelines. Ensure employees remain current with all department and site training requirements. Lead root cause investigations and implement effective corrective and preventative actions related to manufacturing deviations.

Provide leadership and support of safety initiatives within production operations to ensure compliance to OSHA requirements. Ensure tasks are done in accordance with approved site procedures, batch records and protocols.

The candidate will exhibit superior customer-facing skills that instill client confidence and contribute to the support of customer relations. Interact with the customers and represent the company during audits.

As a custom API contract manufacturing organization, our cGMP Manufacturing Supervisors must have strong leadership, technical and communication skills. This role will work rotating shifts.

Who You Are:

Basic Qualifications:

  • Bachelor's degree in a Life Science discipline
  • 2+ years in a cGMP setting, manufacturing
  • 1+ year of Supervisory or Lead experience in a GMP Setting

Preferred Qualifications:
  • Team management or supervisor experience highly preferred
  • Customer Interfacing Audit experience
  • Knowledge of Six Sigma concepts/Lean Manufacturing and process improvement is desired.
  • Familiarity with large scale cGMP process equipment, tangential flow and chromatography automation.
  • Strong Microsoft Office experience for Manufacturing/Operating procedure writing, technical report generation, product tracking and trending data analysis and Operational Excellence reports.
  • Strong interpersonal skills, conflict resolution, motivation, leadership are essential

RSRMS

Job Requisition ID: 210244

Location: St. Louis

Career Level: C - Professional (1-3 years)

Working time model: full-time


This job has expired.

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