Associate Director Manufacturing

Position Title: Associate Director Manufacturing Department: Manufacturing
Reports To: VP and General Manager of Operations Work Location: Decatur, Illinois

Position Summary:
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The Associate Director of Manufacturing will have full day-to-day responsibility for sterile product manufacturing operations and provide strategic direction, leadership, and development of the Manufacturing team. The Associate Director will be responsible for establishing an employee-friendly, high-performance, and quality focused work culture using Lean manufacturing principles. They will ensure compliance with regulatory guidelines, i.e., cGMP, FDA, DEA.  They will utilize Lean concepts in the development of a problem-solving culture and teach associates how to identify and eradicate waste, and complete root cause analysis to drive daily continuous improvement, identify and develop new product opportunities, specifically in sterile products such as injectables (liquid and lyophilized), ophthalmic and controlled substances.

Essential Duties & Responsibilities:
• Provides strategic leadership for bulk formulation, aseptic filling, and manufacturing functions, focused on safety in operations, product quality (cGMP), efficiency, and compliance (FDA, DEA, OSHA) for a portfolio of sterile pharmaceutical products.
• Responsible for the delivery of product by managing daily operations with input from client/customer, Process Development, Manufacturing, Engineering, Validation, Quality Control, Microbiology / Environmental Monitoring and Quality Assurance.
• Manage team to ensure safety, compliance, and production goals are reached.
• Collaborate with Technical Operations to manage the workflows associated with new product introduction and product reintroduction including design of process flow, special handling requirements, equipment fit versus qualified components and processes, bill of materials (BOM) generation, process parameters, automation requirements.
• Review and approve batch records, solution records, and other SOP’s and protocols for new/existing products.
• Review and approve deviation investigations, CAPA’s, technical documents, and Change Controls associated with production. Ensure appropriate root cause investigations are completed and effective corrective/preventative actions are implemented.
• Provide support to the Engineering and Validations teams in preventive maintenance, calibration and equipment and process validation / re-validation activities.
• Identify and support new manufacturing equipment selection, user requirement specification development, protocol development, review and approval and qualification execution.
• Provide on-the-floor technical oversight and manage client interactions as required during cGMP manufacturing runs.
• Serve as SME as required during regulatory inspections for manufacturing operations, departmental training, and associated department deviations, change controls, and process documentation.
• Compile, analyze, and present manufacturing process data to internal and external program teams.
• Manage production deliverables associated with active campaigns in assigned manufacturing area. Ensure production teams are meeting safety, compliance, and schedule objectives.
• Collaborate with Technical Operations and Quality Assurance for batch record review and release timelines. (Repeat of above – so is below)
• Provide on-the-floor support as required and serve as primary contact for technical aspects within each product campaign.
• Hire, develop and motivate the team. Serve as a coach and mentor for reports meeting with them at a minimum frequency based on experience to assure objectives are met.
• In cooperation with customer representatives, process development, engineering, and management personnel, look for opportunities to improve operational efficiencies.
• Development and adherence to manufacturing department budget.
• Closely coordinate potential process improvements with quality and regulatory to assure cGMP and DEA product handling compliance.

Position Requirements:
  • Bachelor’s degree in manufacturing, Operations, Mechanical or Industrial Engineering, science discipline or similar field preferred.
  • Minimum 10 to 15 years’ experience in pharmaceutical manufacturing preferred.
  • Minimum five (5) years leadership experience.
  • Experience with glass vial (liquid and lyophilized), glass ampoule and plastic eye drop bottle aseptic manufacturing a plus.
  • Experience working/scheduling in a multiple shift, multiple product and multiple product container size change-over environment.
  • Strong manufacturing leadership experience in discrete manufacturing environments with demonstrable results.  (Both are stated above)
  • Five-plus years working in strong Lean cultures.
  • Must have had roles with P&L responsibility and must have working knowledge of budgets and financial statements.
  • cGMP, DEA, and OSHA compliance
  • Glass vial (liquid and lyophilized), glass ampoule and plastic eye drop bottle aseptic manufacturing
  • Strong project management abilities
  • Capable of interaction at all levels of the organization
  • Ability to manage and execute several activities at once.
  • Proven strategic leadership and enterprise mindset.
  • High level of financial acuity.
  • Must have a strong drive to understand unknowns, comfortable challenging status quo, prone to ask questions.
  • Strong understanding of US and international regulations cGMPs a plus.
  • Ability to translate complex concepts and information into an easy-to-understand manner to external and internal teams.
  • Demonstrated drive to identify improvement opportunities in products, processes, and people. Ability to provide strong rational and supporting case for proposed improvements.
  • Excellent written and oral proficiency in English
  • Strong personal presence with excellent leadership, communication, interpersonal and relationship building skills.
  • Working knowledge of MS Word, Excel, Outlook, and Power Point
Functional Knowledge:
  • Excellent conceptualizing, analytical and problem-solving skills
Company / Industry Related Knowledge:
  • cGMP, DEA, and OSHA compliance
  • Glass vial (liquid and lyophilized), glass ampoule and plastic eye drop bottle aseptic manufacturing

Job-Specific Competencies:
• Effective written and oral communication skills
• Strong organizational, planning and communication skills.
• Demonstrates exceptional time management skills.
• Using logic and reasoning to identify solutions to problems.
• Ability to multi-task, set priorities and meet strict deadlines.
• Ability to lead, motivate, coach, and teach others

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