| MUST HAVE BIOLOGICS experience get the interview || TECHNICAL WRITER at Lexington, Massachusetts, USA |
| Email: [email protected] |
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From: Aditya Mishra, Anveta [email protected] Reply to: [email protected] TECHNICAL WRITER #9277 ** CLIENT: TAKEDA - LOCATION: Lexington, MA - DURATION: (1) year ++ Must Have's; *** BIOLOGICS experience get the interview !! I want references, with company emails and Manager contact #'s from past (2) assignments, please, to verify this experience! - - Authoring analytical method and support documentation for QC release and stability testing of biologics. - Authoring analytical method and support documentation for QC release and stability testing of biologics. - A GOOD validation / Quality person with EXCELLENT Writing / Documentation skills will be reviewed and considered. *ONSITE* ** Primary duties are non-laboratory support of the QC analytical methods functions in method validation and method transfer projects. ** Primary activities would generally include but not limited to; - Authoring analytical method and support documentation for QC release and stability testing of biologics. - Authoring method validation protocol and reports to support technology transfers. - Creation, review, and revision of comprehensive method validation protocol, reports, , ensuring accuracy and adherence to ICH, FDA, EMA, regulatory standards. SPECIFIC QC FOCUS AREA - Analytical Methodologies for potency, impurities, content, and identity attributes in biologics (recombinant proteins, antibodies, ADCs, fusion proteins, enzymes, etc.). (i.e.: cell based assays, residual ProteinA, host cell protein, residual DNA, protein determination) **- If possible, proven hands-on testing experience in QC laboratories. EXPERIENCE REQUIREMENTS ** Independent Technical Writing Skills in Quality Control and Regulatory departments (must perform the designated author role, not just the reviewer/approver role). - Expert knowledge in data analysis. - Experience on test methods and method validation for internal teams and external partners. KEY SKILLS - Skilled in proper laboratory compliance through detailed documentation practices. - Experienced in the use of electronic laboratory notebooks and electronic data storage systems to maintain accurate records. - Strong written, verbal, and interpersonal communication abilities, successful in a team environment - LIMS and Empower software platforms - Must have knowledge of periodic documentation of assay trends, to maintain compliance and improve operational efficiency Thanks & Regards Aditya Mishra Us IT Recruiter Linkedin- https://www.linkedin.com/in/aditya-mishra-59466823b/ Email: [email protected] | 4694980325 Ext 408 |URL: http://www.anveta.com Address: 1333 Corporate Drive, Suite #108 Irving, TX 75038, USA ANVETA, Inc Keywords: information technology Massachusetts Texas MUST HAVE BIOLOGICS experience get the interview || TECHNICAL WRITER [email protected] |
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| 06:52 PM 12-Mar-25 |