CONTRACT DOCUMENTATION SPECIALIST II
Company: Mindlance
Location: Worcester
Posted on: October 11, 2024
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Job Description:
Skills:
A Bachelor's, Master's or PhD degree in chemical or biochemical
engineering, biochemistry or biology with typically 3-5+ years of
work experience with knowledge of protein purification and standard
analytical techniques is required
Duties:
Scientific writer will work closely with Purification group leaders
and Subject Matter Experts in drafting, formatting and completion
technical documents required for the development and
characterization of biological molecules, from clinical studies to
commercial products.
Responsibilities, under the supervision of a Principal
Scientist:
--- Initiating, drafting, and preparing the first draft of assigned
documents (Process development Reports, Process
characterization/Validation study Protocols and reports, Risk
Assessments report, Drafting/updation of SOPs.
--- Closely working with matrix environment of Purification
development and CMC Project management to teams to document process
risk, characterization, control, and validation matrix.
--- Provide editorial support, ensuring quality of all scientific
content, with a focus on clarity, accuracy, and consistency while
adhering to proper formatting and regulatory requirements
--- Initiate and oversee multiple rounds of document review and
subsequent revisions by proactively interacting purifications
SMEs.
--- Perform data integrity review, process documentation gap
analyses and update platform documents for report requirements.
--- Contribute to overall success of the organization by ensuring
timely completion of documents required project progression, and
other regulatory supporting documents.
EEO:
Mindlance is an Equal Opportunity Employer and does not
discriminate in employment on the basis of -
Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans
Keywords: Mindlance, Marthas Vineyard , CONTRACT DOCUMENTATION SPECIALIST II, Other , Worcester, Massachusetts
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