Scientist, Assay Development

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Job description

Scientist, Assay Development
About us

Founded in 2016 and with three assets in clinical trials, Cartesian is the leader in RNA cell therapy. The company is pioneering RNA cell therapies in and beyond oncology, with products in development for autoimmune, oncologic and respiratory disorders. All investigational therapies are manufactured at Cartesian's wholly owned, state-of-the-art cGMP manufacturing facility in Gaithersburg, MD.

Cartesian Therapeutics is currently seeking an Assay Development Scientist with a track record of research excellence and successful assay development. Expertise in method validation, GLP/cGMP, ICH guidelines, and FDA guidance is preferred. The ideal candidate will be a highly-motivated scientist that can conduct cutting-edge translational science within a robust Quality Management System and enjoys both bench-work and broad responsibilities and opportunities in a rapid-pace cell and gene therapy environment. The candidate should embrace a collaborative work environment and be able to independently troubleshoot and execute multiple projects concurrently. This position is ideal for those candidates who are looking to be a bridge between our R&D and QA/QC teams.

Principal Duties and Responsibilities

· lead multi-disciplinary projects; serve as team member on other teams;

· manage development, qualification, and validation of QC release assays and clinical enabling studies;

· serve as Subject Matter Expert for our Quality Control laboratory and conduct/oversee in-process/release assays for cGMP Manufacturing;

· work closely and cross-functionally with our in-house QA, QC, cGMP manufacturing, process development, technology and R&D teams;

· prepare SOPs, batch records, reports, publications and oral presentations.

Qualifications

· PhD with 0-2 years experience OR

· MS with 3-5 years' experience in biopharmaceutical assay development

· experience in Quality Assurance and/or Quality Control in biopharmaceuticals is preferred but not required;

· expertise in analytical research and assay development;

· extensive experience and understanding of translational analytical techniques including bioassays that utilize model cell lines and/or primary cells, flow cytometry, ELISA, and biological sample handling; and

· experience in the biotech/pharmaceutical industry leading projects and performing laboratory research and/or drug discovery experience preferred but not required.

Job Type: Full-time

Pay: $65,000.00 - $100,000.00 per year

Benefits:

• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Vision insurance

Schedule:

• Monday to Friday

COVID-19 considerations:
Routine testing and other precautions taken.

Education:

• Master's (Preferred)

Experience:

• Cell and Molecular Biology: 5 years (Preferred)
• QA/QC: 2 years (Preferred)
• research and assay development: 2 years (Preferred)

Work Location: One location