Technical Writer - Pharmaceutical Manufacturing

SRG; Upper Uwchlan Township (Chester County); Hybrid; USD 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company seeks a Technical Writer in Upper Uwchlan Township, PA. The role involves authoring technical documents and collaborating with vendors. Candidates should have a BS in a scientific field and at least 2-3 years of relevant lab experience, particularly in protein therapeutics or monoclonal antibody therapies. The position requires proficiency in various lab systems and scientific writing skills. This is a hybrid role requiring onsite presence 2-3 days per week.

Qualifications

• 2-3 years scientific/analytical lab experience in protein therapeutics or monoclonal antibodies.
• Experience in GMP/GLP and/or regulated industry.
• Advanced knowledge in Excel is a plus.

Responsibilities

• Author technical reports and Standard Operating Procedures.
• Review and format reports for regulatory submissions.
• Coordinate with vendors for testing and shipments.

Skills

Scientific/technical writing

Excellent oral communication

Attention to detail

Organizational skills

Education

BS in Chemistry, Biology or related field

Tools

Empower chromatographic data system

LIMS

SAP/SRM

Veeva

TrackWise

Microsoft Word

Microsoft Excel

SharePoint

Job description

Technical Writer - Pharmaceutical Manufacturing

SRG, part of Impellam Group, is recruiting for a Technical Writer, Analytical Outsourcing, Biopharmaceutical Development to join the client's pharmaceutical manufacturing team in Exton, PA.

W2 contract only; we cannot accept C2C at this time. Hybrid remote - onsite 2-3 days per week required. Must be a local resident.

Overview

Join to apply for the Technical Writer - Pharmaceutical Manufacturing role at SRG.

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 - REQUIRED
• 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.

Responsibilities

• 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 forecast.

Job Details

• Seniority level: Mid-Senior level
• Employment type: Contract
• Job function: Writing/Editing
• Industries: Pharmaceutical Manufacturing

EEO Statement

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting [e-mail] or fill out this form to request accommodations.