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Job Details

CMC Team, Manager

Company: RBW Consulting
Location: Bridgewater, NJ
Reference: RA-CMCTM-BNJ
Closing Date: 14 Mar 17
Type: Full Time
Salary (£): Competitive
Benefits: Competitive Benefits Package

Job Summary:

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at (646) 586 9087 today!

Requirements:

CMC Team, Manager

Bridgewater, New Jersey

Our client an emerging pharmaceutical research and drug Delivery Company focused on developing innovative technologies, improved medicines and life cycle management products.

They also offer contract research and development services to pharmaceutical clients in need of formulation and analytical development expertise and/or clinical supply manufacture.

The Senior Quality Assurance Associate is responsible for oversight and monitoring of quality systems ensuring that operations are conducted in accordance with current Good Manufacturing Practice.

Responsibilities:

Key responsibilities of the position include, but are not limited to –

  • Manage a team to support both NDA and ANDA projects filing.
  • Generate, review, and approve all submission documents.
  • Supervise the auditing of analytical testing, IQ/OQ/PQ, and Instrument.
  • Calibration of documents as per cGMP requirements.
  • Perform SOP Training for the department.
  • Maintain Laboratory reference standards.
  • Prepare all test methods and specifications.
  • Responsible for GMP samples and RLD receiving and inventory.
  • Direct the training and development staff.
  • Ensure all project timelines and milestones are met.

Qualifications:

  • MS. with minimum 8+ years experience or
  • Ph.D. with minimum 4+ years experience in Analytical R&D

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at (646) 586 9087 today!

Apply for this job: CMC Team, Manager

Contact Information:

Address:  US Team
Origin Two 106 High Street, Crawley
RH10 1BF
England
Tel:  (646) 586 9087
Website:  Visit Our Web Site

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