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
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
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.