Propharmatech
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Employer Details

Employer ID:

E180

Job Summary

Job ID:

718

Job Industry:

Rx: Sterile non-aseptic

Job Function:

PRODUCTION: COMMERCIAL MANUFACTURING

Job Location:

State: New Jersey

Job Type:

Full-time

Job Description

Supervises:  The Company’s NJ based 503B related Quality Assurance, , Production Manager, Director of Product Development/ Production Supervisor, Director of Supply Chain, Maintenance Mechanic, Supervising 503B Pharmacists, Technicians, Production Support Associates, Clerks, Associates, Shipping Associates   

 

Position Summary

The General Manager (GM) role will be the senior most staff member responsible for GMP produced medicines in the Ledgewood, NJ location, from start to finish.  This role will oversee all aspects of the FDA 503B registered outsourcing facility including but not limited to:  all employees and processes related to the production and manufacturing of all products/medicines produced at this facility, quality assurance/quality control, shipping, regulatory affairs and compliance, inventory/ supply chain & materials management (including Active Pharmaceutical Ingredients (API)) and shipping.  90+% of production is for sterile formulations.

Job Responsibilities:

General Responsibilities:

The General Manager (GM) will lead the facility, monitor departments and all NJ based 503B employees.

Supervisory Responsibility

This role will actively manage and supervise the pharmacists, production technicians, production support associates, shipping and inventory clerks and production, quality and other key associates.

Production and Manufacturing Oversight:

  • Oversee multi-shifts and ensure that every product unit is of high quality and exceeds all the Company’s current Good Manufacturing Practices (cGMP).  Performs final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers in conjunction with QA/QC.
  • Provides cGMP expertise of aseptic drug operations in our 503B registered outsourcing facility 
  • Ensure sterile production operations are properly controlled and regulatory compliance requirements are met by ensuring batch documentation is accurate, Standard Operating Procedures are accurate and personnel training is current, critical documentation templates are accurate, equipment is in good repair and current calibration, and high standards of housekeeping are maintained in all areas of responsibility.
  • Oversee investigations and CAPA actions for non-conformances for Bulk and Sterilized products. Oversee and ensure that SOPs are maintained and other manufacturing specifications and oversee the department budgets.
  • Oversee and monitor KPI’s to improve department metrics including scrap, non-conformance, batch record errors and plant efficiencies.
  • Ensure automation is being optimized in all required areas.
  • Continuously improve workflow and ensure that it is line with the budget, including controlling overtime expenses.

Quality Assurance/ Quality Control:

  • In collaboration with Quality team, provide direction for complex deviations and complaint investigations; manage media deviations, CAPAs and Complaint handling and ensure that complaints are escalated, investigated and resolved in a timely manner.  Coordinate activities to support follow-up on complaint trend investigations for medical (adverse events).
  • In collaboration with Quality, develop and approve cGMP documents including for manufacturing and production area, but not limited to, SOPs, batch records and specifications, ensuring optimal efficiency.  Primary driver for the quality control and compliance aspects of product transfers and organization optimization.
  • Lead or support regulatory or internal audits in partnership with QA. Provides support for quality audits, initial site approvals and due diligence activities.  Develops audit plans, due diligence plans, implements readiness plans, reviews audit observations and responses, and maintain a corrective action plan timetable.
  • Contributes to decisions on product quality, compliance, and regulatory conformance issues for sterile, injectables, solutions, liquid, solids, and other products and medium and high-risk events to Imprimis management.
  • Functions as an additional Quality liaison between third party manufacturers and Imprimis Operations in support of production/manufacturing, commercial operations, new product introduction and/or product transfers.
  • Supports development of the legal supply agreements, contractors, or letters of intent to ensure the appropriate quality compliance; regulatory aspects of the products; services covered; manage the organization’s actions within the legal boundaries of these documents from the production/manufacturing and operational aspect.

Inventory, Supply Chain & Materials Management:

  • Collaborate with the Director of Supply Chain and Inventory Management and oversee Supply Chain to ensure production staff have enough raw materials and API’s to produce products without causing shortages
  • Maintain adequate supply of cleaning materials to prepare for triple cleans; ensure staff are communicated to in advance of this process and that shifts are staggered accordingly so as not to impact production
  • Oversee and ultimately be responsible for production scheduling in avoidance of stock-outs and spoilage

 

Job Requirements

Qualifications:

  • Bachelor's Degree in Life Science or other technical discipline with 10-12+ years of applicable experience [or]
  • A Masters/Advanced degree and 10+ years of experience
  • Understanding and working knowledge of GMP compliance, USP 795, 797 and 800 knowledge and experience
  • At least 7 years of experience in Quality Assurance Operations Management [and] 4 years in Operations, Research and Development.
  • Knowledge and a comprehensive understanding of biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solids, caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions and/or active pharmaceutical ingredients.
  • Strong knowledge and experience with automation systems and related container enclosures (vials, bottles, syringes and other systems).
  • Possesses knowledge and skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem-solving skills interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, members, and individuals.
  • Experience interfacing with regulatory authorities, specifically FDA, regarding cGMP compliance.