Technical Writer, Analytical Outsourcing, Biopharmaceutical

Target Pay Rate: 30-37.57/hr salary will be commensurate with experience

Job Description:

• Author technical reports, policies, and Standard Operating Procedures.

• Author/review, format, and revise reports, protocols, analytical method validations, and CMC sections for regulatory submissions.

• Author investigations, deviations, change controls, and other non-conformance records.

• Work with vendors to coordinate testing and arrange shipments as needed.

• Compile and review scientific data for completeness as needed.

• Perform trending and evaluation for continuous monitoring of stability data and shelf-life extension.

• Use of LIMS database including protocol setup, data entry/approval, and data trending.

• Process invoices, purchase orders, and other agreements. Interact with finance and vendors to confirm work and adjust budget forecasts.

• Coordinate document review, approval, and archiving.

• Participate in analytical testing lab activities, on an as needed basis.

Job Qualifications:

• BS in Chemistry, Biology or a related scientific discipline.

• At least 2-3 years scientific/analytical lab experience, preferably in the field of protein therapeutics or monoclonal antibody therapies.

• Proficient in scientific/technical writing.

Experience in Empower chromatographic data system

• Experience with LIMS, SAP/SRM, TrackWise, and Veeva.

• Excellent oral communication, interpersonal and technical writing skills.

• Excellent organizational skills, demonstrate attention to detail.

• Experience in GMP/GLP and/or a regulated industry.

• Strong background in Microsoft applications such as Word, Excel, SharePoint a must.

• Advanced Excel knowledge is a plus.

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.