Technical Writer III

INTELLISWIFT INC; Santa Monica (CA); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a skilled Technical Writer to join their team in Santa Monica. This role involves authoring critical Module 3 documents and collaborating closely with regulatory experts to ensure compliance with global standards. The ideal candidate will have extensive experience in analytical method development, particularly in the biotechnology sector, and possess strong technical writing skills. You will thrive in a fast-paced environment, contributing to the development of advanced therapy medicinal products while working alongside a dedicated team. If you are passionate about biotechnology and eager to make a significant impact, this opportunity is perfect for you.

Qualifications

• 7+ years of experience in relevant fields with a Bachelor's degree.
• Experience with CMC/Module 3 regulatory submissions.

Responsibilities

• Author Module 3 documents in collaboration with Regulatory CMC experts.
• Develop analytical methods for vector and T cell products.

Skills

Technical Writing

Analytical Method Development

Problem-Solving Skills

Communication Skills

Critical Thinking

Education

Bachelor's Degree in Biochemical Engineering

Master's Degree in Biochemical Engineering

PhD in Biochemical Engineering

Tools

Microsoft Office

Job description

Title: CMCTechnical Writer

Location: Santa Monica, CA, Onsite

Duration: 7 Months Assignment

Responsibilities (include but are not limited to):

1. Author and finalize appropriate Module 3 documents and responses to agency questions in collaboration with Regulatory CMC and Technical Subject Matter Experts.
2. 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:

1. 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.
2. Experience with CMC/Module 3 regulatory submissions.
3. Experience in technical writing and proficient in high quality writing.
4. Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing and analytical and process development.
5. Thorough knowledge of biologics analytical and process development is essential. Cell therapy process development experience is highly desired.
6. Knowledge of product lifecycle – Product and process development, clinical trials, validation and regulatory submissions, commercial GMP manufacturing.
7. Working knowledge of regulatory requirements for biologics, pharmaceuticals and medical devices.
8. Must be able to function and contribute as part of a team, have excellent communication skills and contribute to team-based decisions.
9. Ability to think critically, and demonstrated troubleshooting and problem-solving skills.
10. Self-motivated and willing to accept temporary responsibilities outside of initial job description.
11. Well-developed computer skills and fluent with Microsoft Office applications.
12. Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
13. Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.