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Technical Writer - III

Santa Monica, CA 90404

Posted: 04/10/2025 Employment Type: Contract Job Category: Regulatory Affairs Job Number: 618899 Is job remote?: Hybrid Country: United States

Job Description

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

Pay ranges between $75-80/hr

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Santa Monica, CA

Discover your next career opportunity in the vibrant city of Santa Monica, California! This beachside gem, located in Los Angeles County, offers a perfect blend of work and play. With renowned art galleries like the Bergamot Station Arts Center, iconic landmarks such as the Santa Monica Pier, and a diverse culinary scene that caters to all tastes, Santa Monica provides a unique and exciting backdrop for professional growth. From strolls along the picturesque Palisades Park to catching a show at the historic Santa Monica Playhouse, this area beckons job seekers with its irresistible charm and endless possibilities. Explore our job listings and take the next step towards an enriching career in this dynamic region.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.