Skip to Main Content
← Back to Jobs

Operations Manager

Employers Pro Advantage Newark ,NJ
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

We are currently seeking a Sr. Manufacturing Manager for our client's night shift.  The position is located in Albuquerque, NM.  Relocation assistance is available.

 

  • Responsibilities are for both Drug Substance (API) and Drug Product aspects of commercial pharmaceutical product manufacturing.
  • Develops and maintains good working relationship with contract manufacturers.
  • Manage CMO contracts.
  • Develop SOP’s and work processes needed for Commercial Manufacturing.
  • Works with CMOs to diagnose and correct process issues.
  • Identifies and evaluates CMOs for the manufacture of Commercial products.
  • Develops, collects appropriate metrics to measure CMO performance.
  • Works with Quality Group to determine the impact of process deviations and works towards resolutions.
  • Develops timelines, goals, and deliverables for API, Drug product and related manufacturing processes.
  • Optimizes the manufacturing process to maintain high product quality, improve process portability, increase process robustness, improve process efficiency, and reduce manufacturing costs..
  • With Quality Assurance, ensures CMOs remain current and compliant with all GMP related requirements, guidelines and procedures.
  • Tracks deviations and processes changes for the different suppliers and collaborate with Regulatory Affairs and Quality Assurance in assessing their impact on regulatory filings.
  • Initiates and coordinates the preparation of CMC documentation as required.
  • Collaborates with Regulatory Affairs and other groups to support product filings.
  • Assists in contract site preparation activities for regulatory inspections.
  • Supports interdisciplinary working teams with recommendations, advice and action plans for manufacturing related issues.
  • Provide onsite process coverage as person-in-plant as needed.
  • Communicates manufacturing or technology related issues and information to committees, teams and interested groups within the company.
  • Supervise, train and mentor personnel as needed.
 

Education/Experience/Skills:

 

BS in Engineering/Chemistry/Biology, Masters preferred. A minimum of 10 years of progressively responsible experience within the pharmaceutical/biotechnology industry with 5 years in a leadership role.

 

Requirements:

 

  • Strong understanding is required of the biopharmaceutical drug development process including regulatory filings and quality inspections and audits.
  • Extensive knowledge of regulations as they pertain to post-approval manufacturing process changes; site changes, etc.
  • Demonstrated experience with preparing/reviewing annual product review/product quality review reports.
  • Extensive knowledge of current Good Manufacturing Practices (cGMPs) and demonstrated experience in manufacturing process development for new drugs.
  • Collaborative leader able to operate effectively and with a strong sense of urgency in a fast-paced environment.
  • Hands-on approach with a strategic and operational focus; capable decision maker in the execution of responsibilities with a high degree of flexibility to adapt to company and industry changes.
  • Outstanding communicator: direct, effective, clear, concise, well organized and appropriate.
  • Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.

 

Employers Pro Advantage

Address

Newark, NJ
07108 USA