Analytical Development Technical Writer

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. 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 AD Technical Writer willbe responsible forconsistently generatinghigh qualitytechnical documents, such as test procedures, protocols, and reports based on data collected by other members of the Analytical Development department that meet the needs of other departments, clients, and regulators. Compliance with SOPs, cGMP, ICH, and other regulatory guidelines isrequiredto perform most job tasks.

Responsibilities

• Drafting and revising controlled documents such as test procedures, method evaluation protocols, reports, and SOPs while following established guidelines for correctness, completeness, clarity, and format.
• Coordinate the approvals of these documentsthrough the use ofsoftware such asMasterControlandTrackWise.
• Compile and present data from multiple sources such as laboratory notebooks and various laboratory instrumentation software.
• Maintain open communication with members of AD, QC, and QA to ensuretimelydelivery ofhigh qualitydocuments to support evolving business needs.
• Continuously improve documentation systems to increase efficiency and compliance with cGMP and/or other regulatory requirements.

All employeesare required toadhere to EPA, DEA,FDAand cGMP regulations as they relate to the operation of theCompany;and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in thissectionmay be assigned.

Qualifications/Skills

• Advanced technical writing skills and the ability to communicate effectively with peers, department management, and cross-functional coworkers.
• Fluent in written English.
• Familiarity with compliance requirements within cGMP with an emphasis on method validation and reporting requirements preferred.
• Demonstrated excellence in advanced word processing using Microsoft Word.
• Demonstrated computer literacy, including spreadsheets, structural drawings, databases, and communication packages preferably in a Windows environment.
• Ability to work in a highly independent and self-directed work environment.

Education, Experience & Licensing Requirements

• Bachelor’s degree in Chemistryor closely related fieldrequired.
• Minimum of 2 or more years of experience in acGMP regulatedlaboratory environment highlypreferred.

_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._ _#LI-RD1_