CMC Technical Writer

Job Description

Job Summary:

• 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.

Duties and Responsibilities:

• 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.

Education and Experience:

• 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.

Knowledge, Skills and Abilities:

• 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.