What are the responsibilities and job description for the Technical Writer - III position at Maxonic Inc.?
Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Technical Writer - III
Job Description:
Job Title: Technical Writer - III
Job Location: Santa Monica, CA
Work Schedule: On-site
Starting rate: $80/h W2, Based on experience
Description:
The client 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
About Maxonic:
Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.
Interested in Applying?
Please apply with your most current resume. Feel free to contact Nina (nina@maxonic.com/ 408-400-2299) for more details
Salary : $80
