Supervisor-Analytical Science

Job Description

Company Information

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.

With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.

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.

Job Overview

Our Analytical Services Department is seeking a motivated analytical scientist at the Supervisor level to

oversee a small but growing team of analytical scientists focused on supporting a wide range of clinical

to commercial Quality Control testing workflows as well as analytical development and method

onboarding workflows for drug substance and drug product.

Reporting to the (Manager, Associate Director, or Director), the Analytical Services Supervisor will

provide (with guidance from management) strategic oversight and operational direction for a team of

analytical scientists that may support either development and or quality control testing for small

molecule drug substances and drug products in a fast-paced work environment. The supervisor will be

responsible for operational project planning including resource allocation, project oversight, technical

oversight with some business level management to support ongoing or incoming projects. This role will

interact with clients and is responsible for successfully meeting client and team objectivies in a timely

manner. The supervisor will have direct responsibility over laboratory staff.

Responsibilities

non-GMP projects, including scheduling of assigned staff and equipment and lab productivity

assessments

and reports, and (where required) development reports in accordance with SOPs and ICH and

FDA guidelines. Typical testing includes analysis of potency, purity, and impurities by HPLC / UPLC

PDA / VWD / CAD / ELSD / RID / FLD / MSD), FT-IR, GC-FID / MS, cKF, ROI, Dissolution, etc,

laboratory data included but not limited to, HPLC, GC, IC, FT-IR, KF, and dissolution. Depending

on team size this could be up to approximately 50% of the job requirement.

standard programs

Qualifications / Skills

deviation investigations, and providing support for CAPAs.

Education, Experience & Licensing Requirements

Education

testing environment is required. Experience in analytical development, validations, and method

transfers is required.

Required Knowledge / Skills / Abilities

the pharmaceutical industry.

lifecycle enhancements

driver

organizational skills, and attention to detail.

to work independently with some direction.

meeting and exceeding expectations

Supervision Received : General Supervision

Exercises independent judgment in developing methods, techniques and evaluation criteria for

obtaining results. Acts independently to determine methods and procedures on new assignments.

May seek management direction for problems of diverse and / or complex scope.

Travel : 5 – 10%

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 may be required to use hands to finger,

handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The

employee is frequently required to stand, walk and sit. The employee may be occasionally required

to climb or balance. The employee may be required to regularly lift and / or move up to 10 pounds,

frequently lift and / or move up to 25 pounds and occasionally lift and / or move up to 50 pounds.

Specific vision abilities required by this job include close vision, distance vision, and peripheral

vision.

Environment and Protective Equipment :

The work environment characteristics described here are representative of those an employee

encounters while performing 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 may be occasionally exposed to moving

mechanical parts, high precarious places and vibration. The noise level in the work environment is

usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas

for inspections or work discussions. The employee is required to wear the appropriate personal

protective equipment to perform the job duties. Such personal protective equipment may include

but is not limited to : safety eyewear, various types of respirators / breathing apparatus, lab coats,

gloves, etc.

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.

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.