(Sr.) Manager, QC Microbiology

at  AbelZeta Inc

AbelZeta Inc (AbelZeta) is a biotechnology company focusing on the development of novel cell therapy products for the treatment of advanced solid and hematological malignancies. We are seeking a highly motivated Manager/Senior Manager for Quality Control microbiology at AbelZeta’s GMP facility in Rockville, MD. This role is responsible for supporting Quality Control microbiology testing for in-process control and DS/DP release of multiple cell therapy products at IND and Phase I/II stage, and the routine operation of the GMP facility. This includes the ability to interface with multiple function groups within AbelZeta, the ability to design and perform tasks, collect and review data, interpret results, and investigate and troubleshoot independently or leading a team. This position will report to the head of QC.

QUALIFICATIONS AND REQUIREMENTS:

• Bachelor of science or above in a Life Sciences or related discipline.
• At least 5 years of relevant experience working in a Quality Control work environment, preferably in a regulated environment in the pharmaceutical/biotech industry.
• Working knowledge of cGMP regulations.
• EM experience in sampling in cleanrooms, data analysis and trending, and OOS investigation.
• Experience in aseptic processing under ISO5 and BSL-2 conditions.

PREFERRED QUALIFICATIONS:

• Ability to work in a fast-paced environment with little supervision.
• Ability to manage multiple and varied tasks and prioritize workload.
• Flexibility and adaptability to adjust to changing priorities and unforeseen events.
• Attention to details.
• Excellent time management skills.
• Excellent communication and interpersonal skills

• Manage and lead the QC Microbiology team, including designing/performing the on-job-training (OJT), scheduling, execution, and continuous improvement, etc.
• Provide strategic advice to maintain the contamination control strategy (CCS) and sterility assurance.
• Support design and execution of in-process control and release testing strategy such as mycoplasma, sterility, and endotoxin for multiple cell therapy products.
• Design, support, and lead QC testing related to Aseptic Process Validation (APV) and Aseptic Operator Validation (AOQ).
• Design and perform cleaning validation and raw material testing strategies.
• Responsible for viable and non-viable environmental monitoring (EM) activities within AbelZeta GMP facility.
• Develop control procedure and test methods for critical utilities, including but not limited to compressed airs.
• Development a phase appropriate environmental monitoring (EM) program with a focus on microbiological aspect.
• Document, review, analyze and trend data in the EM program.
• Report and lead the investigation of EM excursions, deviations, out-of-specification results, etc.
• QC Lead in drafting and supporting contamination control risk assessments.
• Author, revise and review qualification/validation protocols, technical study protocols/reports, risk assessments, as well as SOPs.
• Participate in the audit for contract facilities.
• Other tasks assigned.