Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.
Overview
Cambrex Corporation (Cambrex) is a global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 35 years’ experience and a growing team of 2,000 experts, Cambrex is headquartered in East Rutherford, NJ, Cambrex and has twelve operational sites across North America and Europe.
Responsibilities
DUTIES:
- The main purpose of the Analytical Scientist is to carry out analysis to the highest technical standards, on the Active Pharmaceutical Ingredients (APIs) for clients of Cambrex.
- The candidate must be fully conversant with chromatographic techniques, with experience in development of U/HPLC and GC methodology.
- The candidate must also be fully conversant with GMP and 21 CFR Part 11.
Qualifications
QUALIFICATIONS:
- BSc in chemistry or in appropriate area of chemistry.
- > 2 years industrial experience in a pharmaceutical company / contract research organization.
- Experience in Instrumental techniques including HPLC using UV, Charged Aerosol Detection, Mass Spectrometry, GC, KF Coulometry.
- Experience of SOP and Report writing.
- Experience of intermediate level method development is desirable.
- Experience of method validation and transfer is desireable.
- Experience of instrument validation calibration and qualification is desirable.
- Experience of Chromeleon CDS is desirable
- Familiar with working within ISO9001 and/or cGMP quality standards.
- Experience in working independently and within a team in an R&D environment.
- Experience with working safely in a lab environment and adhering to local SHE policies.
- Able to participate in client meetings and discuss technical data clearly and succinctly.
SUCCESS FACTORS:
- Possess excellent oral and written communication skills.
- Be well organised and able to manage high workloads.
- Able to meet deadlines and plan one’s own work effectively.
- Possess excellent problem-solving skills.
- Be commercially aware of business development needs.
- Knowledgeable of the pharmaceutical development continuum of APIs.