Principal Scientist 2 - ARD

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

Principal Scientist 2 - ARD will independently : conduct development and optimization for methods that have no starting point for intermediates and final products. Develop and optimize robust analytical methods for final product that are validatable. Maintain laboratory notebook and perform data review. Maintain lab instrumentation. Conduct method development and optimization on LC / MS and / or GC / MS. Troubleshoot instrument issues. Work with Process Chemistry department to support analytical needs for process development and manufacturing. Ensure compliance with applicable Company SOPs and regulatory guidances. Perform laboratory investigations and non-routine project work including QC issues. Author analytical procedures, protocols, and reports. Act as Analytical lead for internal projects including responsibility for all Analytical aspects of the project from development through technical support of QC for final product release.

With minimal support, lead larger scope projects including cross-site projects within Cambrex.

Responsibilities

Qualifications / Skills

Analytical Chemistry Knowledge : Strong understanding of advanced theories in Analytical Chemistry and method development

Cross Discipline Knowledge : Higher level of understanding of the principles of cross-functional departments, including organic chemistry and engineering

GMP / Regulatory Knowledge : Strong understanding of the GMP landscape and fundamental understanding of the industrial regulatory landscape; Good understanding of site SOPs and regulatory CMC concerns and can answer client questions and help them develop their clinical package

Instrumentation : Advanced knowledge of HPLC, GC, MS, and ability to train and troubleshoot problems with equipment (and help others)

Communication : Excellent written and oral communication skills, often leading technical calls with clients

Problem Solving : Demonstrated ability to perform root cause analysis and solve problems

Time Management : Very good organizational skills and time management. Able to work on several key items at once including two or more medium complexity projects at once

Leadership : Regularly seeks to share ideas and learning across the group / site; pushes new initiatives from the ground up

Technical Documentation and Review : Strong ability to generate key technical documents with minimal RFT issues and to review documents for others. Basic ability to write new SOPs

External Influence : Strong demonstrated ability to independently steer client or technical teams; ability to redirect and point out scope change; good ability to work with site leadership team and steer local initiatives

Industry Credibility and Rapport : Demonstrated reputation as a leader within the Cambrex Analytical community. Good publication record, where possible, and strong contributions to the Cambrex portfolio

Operational Excellence : Demonstrated ability to participate and share leadership on local OE initiatives

Change Orientation : Demonstrated contribution of input and ideas for larger Cambrex system level changes

Education, Experience & Licensing Requirements

years minimum experience or in Chemistry or related field with 12 years minimum experience or Chemistry or related field with 16 years minimum experience in a laboratory environment.

Fundamental Understanding with some of the following analytical technologies :

This position works with and handles hazardous materials and wastes. Responsible for recognizing emergency situations concerning hazardous materials and wastes.

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.