Job Description

Cambrex

Locations: Charles City, Iowa
Categories: Analytical Development
Req ID: 2978

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 2,400 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 medical, dental, vision, Life, LTD, retirement savings and more! Can we make this broader language, so it fits in all markets, e.g., 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, Research and Analytical Development, the

Group Leader, 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 at an industry leader.

Responsibilities

• Safely 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

Education, Experience & Licensing Requirements

• BS 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, FTIR, UV-VIS, NMR, and data stations required
• Experience in pharmaceutical laboratory experience required
• Familiarity with cGMP regulations required
• Working knowledge of Empower 2 beneficial
• Project management experience strongly preferred
• Windows based computer knowledge

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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Cambrex