Associate Manager, Analytical

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

The Supervisor, Analytical is responsible for the supervision of hourly employees in order to meet commitments to safety, environment, regulatory compliance, quality, productivity, and customer requests. As a Supervisor, you will provide direction and leadership for your assigned team in the above areas and drive engagement to ensure goals are met.

This position is also responsible for overseeing employee training, enforcing all rules, policies and procedures, recommending and applying disciplinary action when required, approving purchases, and verifying work hours in timecards.

Responsibilities

• As Supervisor of Analytical Chemistry, you will oversee the day-to-day operations of the analytical chemistry laboratory.

• You will be responsible for ensuring all testing is completed in a timely manner, following written procedures in a cGMP compliant environment, and managing quality events.

• You will ensure the laboratory is maintained in an audit ready state, review data for accuracy and completeness, and write technical documents (e. g. reports, protocols, test procedures, SOPs, etc. ).

• As Supervisor of Analytical Chemistry, you will oversee analysts' testing of client samples (raw materials, pharmaceuticals and medical devices) and ensure analysts receive and are current with training necessary to perform the testing required.

• Additionally, you will supervise compendial method verifications and method transfers.

• Effectively delegate and lead assigned staff, following up to ensure goals are understood and executed to standards, on time, and within budget.

• Ensure all employees are knowledgeable of and adhere to safety policies and procedures, as well as OSHA regulations.

• Carry out supervisory responsibilities including interviewing, hiring & training employees, planning, assigning & directing work, conducting performance reviews, providing feedback, coaching and addressing disciplinary actions.

• Organize, manage, and direct the activities of employees to meet production goals.

• Responsible for effective employee relations. Provides employee coaching and development. Resolve employee issues through problem resolution and works with HR as needed.

• Ensure hourly employees have proper training and tools to meet department goals

• Communicate with Quality team concerning all issues affecting quality.

• Implement and maintain quality systems that ensure procedures and processes are in place to provide products that meet manufacturing specifications and customer requirements; provide tools for educating team members on quality standards and specifications.

• You will also be responsible for coordination of daily laboratory operations to meet established testing requirements and turnaround time commitments to sponsors.

• You will onboard and validate new laboratory systems and equipment as needed.

• Additionally, you will remain current with all USP/EP/JP/AAMI/ASTM/ISO guidelines.

Qualifications/Skills

• Communicate clearly and effectively both orally and in writing with clients and other employees.

• Goal-oriented, with ability to prioritize and manage multiple tasks and numerous projects in a fast-paced environment.

• Strong problem-solving abilities.

• Ability to review, compile, and analyze information to prepare reports.

• Positive attitude and the ability to work in a team environment.

• Maintain a commitment to the company vision, growth of the Microbiology department, and adherence to company quality management systems

• Strong attention to detail, as well as time and resource management

• Multitasking and performing assigned tasks in a timely and efficient manner

• Must be able to work the necessary hours to meet objectives

• Experience with LIMS, eDMS, and electronic quality event modules a plus

Education, Experience & Licensing Requirements

• Bachelor's Degree (or advanced degree) in Chemistry or related science field required.

• 3+ years of experience in a GMP analytical chemistry testing laboratory.

• Experience in a leadership role.

• Experience supporting compendial testing (USP, EP, JP, ACS, FCC, etc. ) for wet chemistry, chromatographic, and spectrophotometric analyses.

• Experience performing root cause analysis for quality events.

• Understanding of basic laboratory and aseptic techniques.

• Experience in a GMP environment.

• Excellent understanding of company SOPs, and regulatory / compendial guidance documents.

Physical Demands, Work Environment, and Travel

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is occasionally required to sit. The employee is frequently required to stand; walk and stoop. The employee must be able to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds. Specific vision ab.