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Clinical Manufacturing Associate job in Rockville at Medix™

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Clinical Manufacturing Associate at Medix™

Clinical Manufacturing Associate

Medix™ Rockville, MD Full-Time

Overview:

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.

Core Responsibilities:

- 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.

Requirements:

- 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.

Apply Today!

Recommended Skills

  • Biopharmaceuticals
  • Medical Writing
  • Clinical Trials
  • Pre Clinical Development
  • Electronic Common Technical Document
  • Good Clinical Practices (Gcp)
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