Analytical Development, Group Leader

Cambrex; Charles City (IA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive benefits package

Healthcare

Life insurance

Retirement planning

Job summary

Cambrex is seeking a Group Leader of Analytical Development in the United States to supervise day-to-day laboratory activities and lead development, validation, transfer, and verification of analytical methods on site.

You will train staff, support career development, manage projects, interact with customers, and ensure compliance with GMP/SOPs while coordinating off-site testing and R&D initiatives.

Qualifications

• Validated analytical methods supporting production in a GMP environment.
• Strong knowledge of cGMP, safety, and regulatory requirements.
• Experience with analytical instrumentation and method transfer.

Responsibilities

• Supervise a group of 5-8 staff to develop, validate, and transfer analytical methods.
• Lead project communications with clients via meetings and emails.
• Drive cross-functional efforts for method transfer to QC and Process Support.
• Provide guidance for cross-functional project teams and training.

Skills

Analytical method validation

Leadership

GMP compliance

Project management

Customer interaction

Communication

Education

BS Chemistry with analytical emphasis

MS beneficial

Tools

HPLC

GC

LC/MS

FTIR

UV-VIS

NMR

Empower 3

Job description

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.

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.

Job Overview

The Group Leader of Analytical Development will supervise day to day laboratory activities while providing leadership in the development, validation, transfer, and verification of the analytical methods used on site. This supervisory role will be focused on training of staff, career development support, project management, customer interaction, provide management oversight project results reporting, team collaboration, plant support work and bench to analytical technology transfer.

Responsibilities

• Safely and efficiently managing a group of 5-8 direct reports with varying levels of experience and degrees to develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products.
• Effectively and professionally communicating project status to internal and external clients during weekly teleconferences and email correspondence.
• Investigating and solving analytical technical issues.
• Assisting with or leading efforts to transfer documented analytical methods to Quality Control and Process Support departments
• Providing guidance and/or project leadership for cross functional project teams
• Providing guidance to laboratory personnel on safe laboratory practices
• Perform analytical chemistry assays based on new and existing methodologies and qualify reference materials.
• Training staff on analytical techniques and instrumentation
• Participating in the evaluation of new business opportunities
• Maintaining laboratory notebooks documenting work and writing technical reports to document analytical methods
• Maintain compliance with GMP SOPs and DEA regulations
• Coordinate off-site testing as necessary
• Participation in design/execution in R&D initiatives
• Grow/maintain connections with dependent departments

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, 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 3 beneficial

Education, Experience & Licensing Requirements

• 4 year degree in Chemistry, with analytical emphasis. Advanced degree beneficial
• 8 or more years of industrial experience in a method development 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 / Affi...