Job Description
Details
Site Code:
US603
Requisition ID:
GILDJP00016207
Requisition Title:
Technical Writer - III*
Description:
Contractor Role JD: CMC TW/Technical Role
Kite is seeking a highly motivated individual with
late-phase CMC technical experience, including technical and regulatory
submission experience. This position is part of the Process Development
organization and in this role, this individual will be supporting the internal
Process Development teams. In the near-term, this role will support time
critical CMC Regulatory submissions. Longer-term, this individual will be
embedded in technical teams within the Process Development department
supporting CMC aspects of our growing pipeline projects.
Responsibilities (include but are not limited to):
•
Author
and Finalize appropriate Module 3 documents and Response to Agency Questions in
collaboration with Regulatory CMC and Technical Subject Matter Experts
•
Experience
in analytical method development of vector and T cell, extended
characterization of vector and T cell products, awareness of ICHs and global
compendial requirements governing analytical development and
characterization/comparability of Advanced Therapy Medicinal Products and
vector intermediates.
Requirements:
•
Bachelor's,
Master's Degree, or PhD in Biochemical Engineering, Chemical Engineering,
Biomedical Engineering, Biotechnology, Biology, Biochemistry or equivalent with
7+ years (Bachelors), 5+ years (Masters), 3+ years (PhD) of relevant experience
•
Experience
CMC/Module 3 regulatory submissions
•
Experience
in technical writing and proficient in high quality writing
•
Demonstrated
knowledge of pharmaceutical manufacturing of biotechnology products, aseptic
processing and analytical and process development
•
Thorough
knowledge of biologics analytical and process development is essential. Cell
therapy process development experience is highly desired
•
Knowledge
of product lifecycle – Product and process development, clinical trials,
validation and regulatory submissions, commercial GMP manufacturing
•
Working
knowledge of regulatory requirements for biologics, pharmaceuticals and medical
devices
•
Must
be able to function and contribute as part of a team, have excellent
communication skills and contribute to team based decisions
•
Ability
to think critically, and demonstrated troubleshooting and problem solving
skills
•
Self-motivated
and willing to accept temporary responsibilities outside of initial job
description
•
Well-developed
computer skills and fluent with Microsoft office applications
•
Excellent
interpersonal, verbal and written communication skills are essential in this
collaborative work environment
•
Comfortable
in a fast-paced environment with minimal direction and able to adjust workload
based upon changing priorities
Coordinator:
Miramontes, Alejandra_gild
Requisition Start Date:
05/05/2025
Requisition End Date:
12/31/2025
Business Unit:
Gilead Sciences
Site:
US - CA -
Santa Monica
Location:
US - CA
- Santa Monica
Requirements
Title: CMC TW/Technical Role
Pay: $84.00 (79.00 with $5 referral)
Location: Santa Monica, CA
• Bachelor's, Master's Degree, or PhD in Biochemical Engineering,
Chemical Engineering, Biomedical Engineering, Biotechnology, Biology,
Biochemistry or equivalent with 7+ years (Bachelors), 5+ years (Masters), 3+
years (PhD) of relevant experience
• Experience CMC/Module 3 regulatory submissions
• Experience in technical writing and proficient in high quality writing
Requisition ID:
GILDJP00016207
Requisition Title:
Technical Writer - III*
Requisition Start Date:
05/05/2025
Message Body:
Hello All, responding to an email question: Ideal candidate is hybrid
and those will be prioritized but if none can be found, HM is opened to fully
remote.
Forum Type:
Buyer
Supplier
Logged User Name:
Miramontes, Alejandra_gild
Supplier:
-
Worker Name:
-
Thanks & Regards
Maxwell Ghanizadeh
Account Manager
Management Consulting Group