Gandiv Insights LLC
Overview
Client is seeking a highly motivated individual with late-phase CMC technical experience, including technical and regulatory submission experience. This role is part of the Process Development organization and supports internal Process Development teams. In the near term, the role will support time-critical CMC regulatory submissions; longer term, the role will be embedded in technical teams within Process Development supporting CMC aspects of pipeline projects.
Responsibilities
- Author and finalize appropriate Module 3 documents and responses to Agency Questions in collaboration with Regulatory CMC and Technical Subject Matter Experts.
- Experience in analytical method development of vector and T cell products, 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.
Qualifications
- Bachelor's, Master's, or PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry or equivalent with 7+ years (Bachelor's), 5+ years (Master's), 3+ years (PhD) of relevant experience.
- Experience with CMC/Module 3 regulatory submissions.
- Experience in technical writing and proficiency 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; 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.
- Ability to function and contribute as part of a team with excellent communication skills and a collaborative, team-based approach.
Details
- Seniority level: Mid-Senior level
- Employment type: Contract
- Job function: Marketing, Public Relations, and Writing/Editing
- Industries: Professional Services
Location & Compensation
Culver City, CA
Salary range: $110,000.00 - $118,000.00
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