Group Leader, Analytical Development

Found in: Resume Library US A2 - 1 week ago


Charles City Iowa, United States Cambrex Full time
Overview:
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.

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 / Skills::
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

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

 



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