Senior Scientist, Quality Control

2 months ago

Frederick, United States Cartesian Therapeutics Full time
Job DescriptionJob Description

Summary

The Senior Scientist Quality Control will be responsible for leading the QC laboratory team and ensuring the execution of QC operations in support of manufacturing. This includes overseeing in-process testing and lot release testing to ensure product quality and compliance with regulatory standards. Additional expectations include the optimization and implementation of novel analytical techniques. The ideal candidate will have a strong background in QC, excellent leadership skills, the ability to thrive in a fast-paced, collaborative environment and the ability to work independently and develop novel analytical techniques.


Principal Duties/Responsibilities:

  • Provide technical guidance to the QC laboratory team, including training, mentoring, and performance evaluation.
  • Oversee daily QC operations to ensure timely and accurate in-process testing and lot release testing.
  • Develop, implement, and maintain QC protocols, procedures, and documentation to ensure compliance with regulatory requirements (e.g., FDA, EMA).
  • Collaborate with the manufacturing team to provide QC support and troubleshoot issues related to product quality.
  • Review and approve QC test results, ensuring accuracy and consistency.
  • Conduct investigations and root cause analysis for any deviations or non-conformances in QC processes.
  • Ensure proper calibration, maintenance, and validation of QC equipment and instruments.
  • Prepare and present QC data and reports to senior management and regulatory authorities as required.
  • Stay current with industry trends, advancements, and regulatory changes affecting QC practices.
  • Foster a culture of continuous improvement within the QC team.

Qualifications:

  • Ph.D. in a relevant scientific discipline (e.g., Biology, Chemistry, Biochemistry) with 2+ years of QC experience, or M.Sc. with 5+ years of QC experience in the biotech or pharmaceutical industry.
  • Proven experience leading and managing a QC laboratory team.
  • In-depth knowledge of QC methodologies, including in-process testing and lot release testing.
  • Familiarity with regulatory requirements and quality standards (e.g., cGMP, ICH guidelines).
  • Strong analytical, problem-solving, and decision-making skills.
  • Excellent communication and interpersonal skills.
  • Ability to work effectively in a team-oriented, collaborative environment.
  • Proficiency with laboratory information management systems (LIMS) and other relevant software.

Work Environment:

The position requires hands-on work setting up and operating equipment in R&D and manufacturing environments. An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention. Strict adherence to Cartesian's policies, rules and regulations is required. While performing the duties of this job, the employee handles hazardous chemicals in the laboratory. The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, shoes, and lab coat. Position may require extended periods of standing.

Cartesian is an Equal Opportunity Employer and is committed to fostering an environment in which all employees are treated fairly without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, ancestry, disability, marital status, genetic information, military status, or any other characteristic protected under applicable law.


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