Provide technical writing for the Analytical Development department and cross-functional teams as needed. Ensure consistency, quality and timeliness of all submissions to clients, both internal and external.
Create and review department SOPs and other technical documents, maintain and revise as required, and drive consistency, efficiency and identification of best practices for these documents.
Perform and write thorough risk assessments on behalf of Analytical Development, the Material Review Board, and other groups, as needed.
Partner with Analytical Development scientists to summarize and write research and validation reports, test methods, client protocols, and various other scientific documents.
Partner with Regulatory to author drug master file sections, CMC, IND, audit responses, and other documents related to Testing, as needed.
Assist with business development proposals and other technical documents for cell and gene therapy development programs, as needed.
Ensure accuracy, completeness, and clear presentation of all authored and reviewed documents.
Other duties as required by management.
Education / Qualifications:
Experience / Skills
Excellent writing skills is required.
Experience performing risk and/or impact assessments is required.
Experience writing technical documents regarding assay development is required.
Pre-clinical development, CMC, and cell and gene therapies experience is a plus.
Strong oral and written communication skills with the ability to convey complex information in a way that others can readily follow.
Must possess the ability to provide constructive criticism of other's writing in a professional manner.
Strong organizational skills, ability to multi-task, and the ability to meet strict timelines.
Experience using MS Office products.
Possess the skills to work both independently and as part of a team in a fast-paced, deadline-driven environment.
Attention to detail and ability to self-prioritize work on an ongoing basis.
Must be able to work in an office environment with minimal or variable noise conditions.
Must be able to work in Lab setting with Biohazards/various chemicals.
Must be able to wear appropriate PPE, if needed.
Ability to stand/sit/walk for long periods of time.
Clarity of vision.
Must be able to perform activities with repetitive motions.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability