- Oversight of QC analytical testing laboratories at New Horizon, including in-process testing and lot release QC testing
- Develop and execute analytical method validation protocols
- Method transfer between multiple manufacturing sites and phase appropriate qualification/validation of analytical methods from Analytical Development or to QC as well as the transfer and validation of methods between manufacturing sites.
- Develop, revise, and review SOPs, qualification/validation protocols and reports.
- Responsible for conducting laboratory investigations, OOS, OOT. Generation of CoAs for product release.
- Draft/review global regulatory submissions.
- Monitor and trend data while assembling reports on product release test. Frequently update stakeholders on trends and implement corrective action plans.
- Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
- Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products.
- Required to build a quality mentality with the team by facilitating the desired 'way of working' through actions, coaching and mentoring.
- Perform routine quality control testing on raw materials, process intermediates, and final cell therapy products using established protocols.
- Perform a broad variety of basic and moderate complex tests and validations in support of lab operations, including but not limited to ELISA, flow cytometry, and qPCR..
- Record and document all quality control testing activities accurately and in compliance with cGMP regulations and company procedures.
- Perform routine lab maintenance, including equipment qualification/maintenance.
- Monitor and trend data while assembling reports on product release test.
- Frequently update stakeholders on trends and implement corrective action plans.
- Perform other duties as desired.
- 6yrs equivalent experience in quality control testing, and GMP;
- Mandatory experience in Cell or Gene Therapy.
- Preferred experience in leading both early phase qualification and late phase validation.
- Work experience in a cGMP environment with supervisory and qualification responsibilities.
- Experience authoring and/or reviewing Deviations, Investigations, CAPA and/or Change Control.
- Demonstrated ability to take ownership, initiative, and self-accountability.
- Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced dynamic team setting.
- Attention to detail and quick learning/application of concepts and information
- Identifying, evaluating and closing OOS's and investigations.
- Knowledge of cell culture techniques and proficient in MS Word, Excel, Power Point and other applications.
- Familiar with equipment IQ/OQ/PQ in a QC setting.
- Ability to communicate and work in a self-guided manner with scientific/technical personnel.
- Well versed in various analytical techniques such as FACS, ELISAs, and PCR, .
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
- Identifying, evaluating and closing OOS's and investigations.
- Knowledge of cell culture techniques.
- Ability to communicate and work in a self-guided manner with scientific/technical personnel.
- Comfortable in an adaptable small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
- Ability to think critically and demonstrate troubleshooting and problem-solving skills.
- Excellent interpersonal, verbal, and written communication skills.
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Senior Scientist, Associate Director, Quality Control - Frederick, United States - Cartesian Therapeutics
Description
Job Description
Job DescriptionSummaryCartesian Therapeutics is seeking a Senior Scientist/Associate Director, QC for the company's New Horizon facility. You will oversee QC analytical testing laboratories, including in-process testing and lot release QC testing. The Senior Scientist/Associate Director, QC will have both quality control and method validation experience; specifically, experience leading both early phase qualification and late phase validation.
Principal Duties/Responsibilities:
Qualifications:
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.
