Job Title: Formulation Development Associate

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. Start a career where You Matter by applying today!

Job Overview

Position is directed toward optimization of existing chemical routes and development of alternate chemistry toward key synthetic intermediates and APIs. Carries out multistep chemical synthesis and
product isolation/purification operations in the laboratory, independently or as part of an integrated team. Chemist utilizes modern analytical tools to determine identity and purity of products made
during projects. Communication with clients in regular team meetings; prepares R&D reports at the conclusion of projects.

Responsibilities

Design and carry out multistep organic syntheses, isolation, and purification of targeted products. Must possess a strong understanding of modern organic synthesis methodologies. Must have a thorough understanding of modern analytical and spectroscopic techniques and be able to interpret the corresponding data and spectra.
Ability to conduct literature searches for specific target compounds and be able to use the literature to base a design of alternate routes to these compounds. Requires ongoing professional development to keep abreast of current scientific literature and discuss these
findings with colleagues.

Must demonstrate a proficiency to carry out laboratory syntheses and purification techniques on scales ranging from milligrams to several kilograms, and design and implement process modifications.
Requires excellent time management with the ability to manage projects on-time without supervision.
Ability to author and review comprehensive reports at the conclusion of projects for internal and customer use.
Work closely with other chemistry and analytical laboratory staff to coordinate project activities and resource usage.

Work to ensure that a spirit of teamwork and cooperation always exists within the group. Conduct laboratory operations in a safe manner. Maintain familiarity with the company’s chemical hygiene plan. Exhibit safety awareness and safe work practices.

Follow responsible actions regarding chemical disposal. Maintain compliance with all regulations at the federal, state, and local levels. Must demonstrate effective communication skills (both interpersonal and presentations).
Participate in project team meetings with customers.

Work closely with manufacturing and GMP operations to coordinate project related equipment and activities.

Qualifications/Skills

Organic Chemistry Knowledge: Strong understanding of advanced theories in Organic Chemistry/Process Development.

Cross Discipline Knowledge: Good understanding of the principles of cross-functional departments,including analytical 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 that can help to develop their clinical package.

Instrumentation: Advanced knowledge of HPLC, NMR, MS, automated reactor platforms, in-situ reaction monitoring, 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: Demonstrated record of mentorship and development of peers, partner lines and ability to support initiatives within the department.

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 SOP, keep current
lab notebook while practicing GDP.

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

chemical development 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

Ph.D. in Chemistry or related field with minimum 8 years of experience or M.S. in Chemistry or related field with minimum 12 years of experience or B.S. degree in Chemistry or related field with 16 years of experience in lab environment, pharmaceutical experience preferred.

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.