cGMP Manufacturing Supervisor

Job description

cGMP Manufacturing Supervisor

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.

 

Your role:

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.

 

Who you are:

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.  Select, train, develop, motivate and evaluate employees. Assist in the on-boarding of new employees.

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).

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.).

Provide strong avenue of communication for employees and ensure information is passed on to employees in a timely fashion through weekly meetings and shift pass downs. Communicate the group’s status, data and feedback to management. 

Responsible for the Management of CERs for equipment and facility improvements. 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.

Superior customer facing skills that instill client confidence.  Maintain technical excellence.

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.   

 

Basic Qualifications:  

·  B.S. or Higher in Life Science  . 
·  1+ Year of Supervisory experience in a GMP Setting 

 

Preferred Qualifications:

·  Strong Interpersonal skills, conflict resolution, motivation, leadership are essential
·  3+ years in a cGMP setting, manufacturing preferred.
·  Knowledge of Six Sigma concepts and process improvement is desired. 
·  Full understanding of current Good Manufacturing Practices  
·  Familiarity with analytical instrumentation and cGMP process equipment 
·  This role requires a working knowledge of Microsoft Office based programs for Manufacturing/Operating procedure writing, technical report generation, product tracking and trending data analysis and Operational Excellence reports.

 

RSRMS

Job Requisition ID: 204615

Location: St. Louis

Career Level: D - Professional (4-9 years)

Working time model: full-time

US Disclosure
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.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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