The Manufacturing and Clinical Operations Associate works within the Manufacturing department to provide hands-on technical support for all aspects of cGMP cell therapy manufacturing. This position focuses on logistic support for clinical trials. The Manufacturing & Clinical Operations Associate is expected to work well in both team-oriented and individual environments. They will assist in monitoring process performance at the post-manufacturing biorepository and distribution facility to ensure successful delivery of clinical trial material with regard to time, quality, and cost. The Manufacturing & Clinical Operations Associate is expected to be self-motivated to complete assigned tasks and communicate results to their supervisor in a timely manner.
- Project management liaison with clinical supply contract vendor
- Person in plant (PIP) during investigative product (IP) packaging activities for clinical trials.
- Monitor Process Performance and assessment of drug packaging process at the contract vendor facility.
- Must be familiar with drug packaging and clinical trial logistics
- Assist in planning, writing, and managing the execution of clinical packaging protocols
- Provide Quality Assurance (QA) with technical support for process discrepancies and deviation investigations.
- Coordinate and track clinical shipments
- Plan and track domestic and international material shipments.
- Accountable for the integrity and tracking of all cGMP storage for both clinical material and cell banks.
- Review in-house clinical documentation, policies and work instructions
- Review and track clinical and biorepository storage invoices
- Reports progress to supervisors and attend progress meeting regularly.
- Maintains a familiarity with current and emerging technologies through reading and understanding scientific and technical literature
- Complies with quality systems and all pertinent safety policies, rules and regulations.
- BS or MS degree in Biology or related discipline.
- Understanding in cell and molecular biology technique for the identification and validation of drug targets.
- 3-5 years of biotechnology, pharmaceutical cGMP manufacturing experience
- Clinical drug packaging and processing experience preferred
- Strong interpersonal, attention to detail, communication, and organizational skills
- Good documentation (GDP) and organizing skills are recommended.
- Self-directed and self-motivated: demonstrate ability to work both independently and as a team member in a matrix environment.
- Exceptional oral and written English communication skills
Compensation: $70k (dependent upon experience)
This position is direct hire.
- Medical Writing
- Clinical Trials
- Pre Clinical Development
- Electronic Common Technical Document
- Good Clinical Practices (Gcp)