GILDJP00016207 Technical Writer - III* avail for w2 ref

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