Job Information
Cambrex High Point Group Leader, Analytical Development in Charles City, Iowa
Company Information
You Matter to Cambrex.
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to:
engage in work that matters to our customers and the patients they serve
learn new skills and enjoy new experiences in an engaging and safe environment
strengthen connections with coworkers and the community
We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!
Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!
Job 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
Education, Experience & Licensing Requirements
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
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.
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