(Sr.) Manager, QC Microbiology

Job Description

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.

Responsibilities and Duties:

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.

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

Why You Should Join AbelZeta

Join a high-growth and fast-paced organization.

Defined career path and annual performance review and feedback process.

Comprehensive Benefits Plan, including 100% company paid medical, dental, vision, life Insurance, short-term and long-term disability insurance, and more!

Competitive company 401k match.

Paid holidays, sick leave, and annual leave.

AbelZeta is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. AbelZeta validates right to work using E-Verify. Salary at AbelZeta is determined by various factors, including but not limited to location, the individual’s particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements. The estimate displayed represents the typical salary range for this position and is just one component of AbelZeta’s total compensation package for employees.