Job Description:
Job Title: CMC Technical Writer
Location: Santa Monica, CA 90404 (50% Remote)
Duration: 06+ Months (Extendable)
Pay Rate: $80.00 – 85.00/hr. on W2
2 openings.
Description:
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
Regards,
Kajal Singh
IT & Engineering Recruiter (Pharma and Life Sciences)
Net2Source Inc.
Global HQ Address –270 Davidson Ave, Suite 704, Somerset, NJ 08873, USA
Office: (201) 340-8700 x 980 | Cell: (201) 777-4217 | Fax: (201) 221-8131| Email: [email protected]
...Performance Based Logistics-Organic (PBLO) within the C4ISR Restoration Depot. Technical support includes in-house expertise regarding the... ...experience. Extensive working experience with Microsoft Office Suite, including internet research skills. Able to work professionally...
A leading food service company in Chicago is seeking a Warehouse Manager to oversee first-shift operations at their facility. The ideal candidate will manage daily operations, ensuring safety and quality while leading a team. Responsibilities include policy enforcement,...
Account Specialist Linea Psichiatria Chieti, L'Aquila, Pescara, Teramo Lundbeck e un'azienda biofarmaceutica multinazionale specializzata da oltre 70 anni esclusivamente nelle neuroscienze con l'obiettivo di migliorare la vita delle persone con patologie neurologiche e ...
...data has led to AI advancements for the world's leading AI labs and large language model builders. Weve built a best-in-class remote work platform for our freelance contributors to provide valuable, specialized skills, and we in turn strive to provide them with a...
...people and build communities to create economic opportunity for all. About the team and the role: Goldin requires a Business Intelligence Analyst to help drive clarity, visibility, and insight across all areas of our business. This role is ideal for someone who...