Group Leader, Analytical Development at Cambrex in Charles City, Iowa

Posted in Information Technology 7 days ago.





Job Description:


Cambrex


Location: Charles City, IA, USA
Department: Research and Development


  • GENEROUS RELOCATION ASSISTANCE!!
  • #1 small molecule API Contract Manufacturing Organization (CMO) in the USA
  • Double digit sales growth each of the last 5 years
  • Recent $75 million expansion of our large-scale API facility
  • IOWA - Ranked #1 state for best place to live by US News and World Report
  • Leading Western supplier of generic APIs including ADHD and other controlled substances


Position Summary:

Reporting to the Director, Analytical Development, the Group Leader of Analytical Development will provide management oversight and leadership to a group of approximately 5 to 8 direct reports with varying levels of degrees and experience. Strict compliance with cGMP guidelines is required to perform most job tasks.

Accountabilities and Responsibilities:
  • Safety and efficiently manage a group of 5-8 direct reports with varying levels of experience and degrees, in order to develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products
  • Effectively and professionally communicate project status to internal and external clients during weekly teleconferences and email correspondence
  • Investigate and solve analytical technical issues
  • Assist with or lead efforts to transfer documented analytical methods to QC and PSG departments
  • Provide guidance and/or project leadership for cross-functional project teams
  • Provide guidance to lab personnel on safe lab practices
  • Perform analytical chemistry assays based on new and existing methodologies and qualify reference materials
  • Training staff on analytical techniques and instrumentation
  • Participate in the evaluation of new business opportunities
  • Maintain lab notebooks documenting work and writing technical reports to document analytical methods
  • Maintain compliance with cGMP SOPs and DEA regulations
  • Coordinate off-site testing as necessary


Qualifications:
  • 4 year degree in Chemistry, with analytical emphasis. Advanced degree preferred.
  • At least 5 years of industrial experience in a method development role and validation role with a focus on small scale pharmaceutical method validation
  • Demonstrated success in validating analytical methods to support production in a safe, efficient and economically viable manner
  • Mastery of compliance requirements within cGMP, safety, and regulatory environments required
  • Strong operational knowledge of analytical instrumentation including HPLC, GC, GPC, LC/MS, GC/MS, FTIR, UV-VIS, NMR, and data stations required
  • Experience in pharmaceutical laboratory experience required
  • Familiarity with cGMP regulations required
  • Working knowledge of Empower 3 beneficial
  • Project management experience strongly preferred
  • Windows based computer knowledge


Cambrex Charles City offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision care and prescription, life, LTD, STD; 401(k) with employer match; tuition reimbursement; and the 'Arthur I. Mendolia Scholarship Program.' Relocation assistance will be offered for this position.

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