Bryllan LLC
  • 19-Mar-2018 to 18-May-2018 (EST)
  • Quality
  • Brighton, MI, USA
  • Full Time

Bryllan LLC is a privately owned, rapidly growing Contract Manufacturing Organization (CMO) that has designed a unique sterile filling and containment platform for multi-product filling of cytotoxic, potent, live virus and vaccine, and hormone drug products. We offer a rewarding work environment while maintaining a small company, employee-focused atmosphere. Bryllan differentiates itself from our competitors by living our values of Integrity, Quality and Service. 

Bryllan is currently seeking a Senior Analytical Chemist responsible for testing of raw materials, in-process materials, and finished products to support release and stability programs.  Additional requirements may include analytical method development, method transfer/verification activities, and procurement/qualification of laboratory equipment.

The selected candidate will perform the following duties:

  • Perform analytical assays to test the integrity and identity of raw materials, excipients and finished products. 
  • Perform testing per current US and European Pharmacopoeia following cGMP's in compliance with FDA and other regulatory bodies such as DEA, OSHA, ICH, etc.
  • Document laboratory work using laboratory notebooks/worksheets in a detailed and accurate manner that meets cGMP requirements. 
  • Perform thorough peer review of data, reports and notebooks to ensure accuracy of raw data and calculations.
  • Assist in training others in laboratory procedures.
  • Installing, qualifying, calibrating and maintaining instruments and equipment.
  • Perform all work using appropriate safety measures personal protective equipment.
  • Write and execute validation and method transfer protocols, conferring with management and external customers.
  • Write and revise laboratory SOPs as needed.
  • Perform and document laboratory investigations when necessary.
  • Assist with maintaining the laboratory consumables inventory and laboratory housekeeping.
  • Assist with coordinating analyses at third party vendor laboratories.

Requirements for this role include:

  • Bachelor's degree in Chemistry or related life sciences.
  • Minimum five years of experience with analytical techniques such as chromatography (HPLC, GC, TLC), spectroscopy (NIR, FT-IR, UV-VIS), manual and Karl Fischer titrations, pH and conductivity determinations, viscosity, bacterial endotoxins test (LAL gel clot) and total organic carbon (TOC) testing.
  • Experience with and application of CGMPs, USP/NF, FDA Guidelines and ICH Guidelines within the pharmaceutical industry.
  • Excellent oral and written communication skills.
  • Ability to develop, troubleshoot, and validate analytical methods. 
  • Ability to troubleshoot laboratory instrumentation.
  • Working knowledge of standard software applications such as Chromatography Data Systems, Microsoft Office and ERP.

 

If you are interested and qualified for this role, please apply.  Other openings, including potential future opportunities can be found at Bryllan.com/careers.

Bryllan LLC
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