Management Consulting Group · 1 month ago
GILDJP00016349 Technical Writer \- III* avail for w2 ref
Santa Monica, California, United States
Full-time
Onsite
Senior Level
$84/hr - $84/hr
5+ years expManagement Consulting Group is seeking a highly motivated Technical Writer with late-phase CMC technical experience. In this role, the individual will support internal Process Development teams and assist with time-critical CMC Regulatory submissions.
Human ResourcesRecruitingStaffing Agency
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
Qualification
Required
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
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
Preferred
Cell therapy process development experience is highly desired
Company
Management Consulting Group
Management Consulting Group is a staffing company that offers recruiting and managed services.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Todd Ghanizadeh
Chief Executive Officer
Company data provided by crunchbase