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MUST HAVE BIOLOGICS experience get the interview || TECHNICAL WRITER at Lexington, Massachusetts, USA
Email: [email protected]
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
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06:52 PM 12-Mar-25


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Location: Lexington, Massachusetts