Director of Sterile Manufacturing

Location: Buena, NJ

Job Summary:

The Director of Sterile Manufacturing will be responsible for all personnel and activities along with all other required functions to support the formulation, filling, inspection and packaging of sterile product.  This person will ensure that all activities in the area are performed in compliance with all cGMP’s, SOP’s, company policy, and batch record procedures.

Essential Responsibilities

  • Direct and oversee the sterile manufacturing processes.
  • Monitor and evaluate workflow and production methods and makes process improvements.
  • Oversees staffing, scheduling and training for production.
  • Ensures manufacturing performance and quality goals are met.
  • Prepares production, staff, and financial reports.
  • Creates functional strategies and specific objectives and develops budgets/policies/procedures.
  • Provide oversite and guidance in the execution of the production schedule.
  • Maintain cGMP’s in the Aseptic production areas.
  • Work directly with Quality and Microbiology to address all environmental concerns and proactively prevent reoccurrences.
  • Key participant in inspections and audits by internal and external agencies.
  • Responsible for Aseptic technique of all employees.
  • Ensure procedures are being followed.
  • Review, edit, and generate SOP’s and batch records as required.
  • Maintain a clean and safe work environment.
  • Monitor equipment for necessary maintenance, improvements, or upgrades.
  • Assume other activities and responsibilities as directed.

 

Qualifications:

 

  • Minimum Bachelor’s degree in a science or technical degree (Master’s degree preferred).
  • 10-15 years supervisory experience in a cGMP manufacturing environment required.
  • 5-10 years’ experience in aseptic production and media fill programs is required.
  • Excellent computer and math skills
  • Experience with isolators preferred.
  • Self-starter with strong analytical and reasoning abilities.
  • Participative management type – advocates team concept.
  • Well-developed interpersonal skills.  Ability to get along with diverse personalities.
  • Ability to establish credibility and be decisive, but able to recognize and support the organization’s preferences and priorities.
  • Excellent written and verbal communication skills.

 

Physical Demands/Factors:

  • While performing the duties of this job, the employee is regularly required to stand.  The employee is frequently required to walk; sit; use hands; talk; and hear.  The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds.  Specific vision abilities required by this job include close vision, distance vision, and color vision.
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs

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