- 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.