Responsible for supervising Quality Control activities within the production facility. Demonstrates strong supervisory skills and contributes to the achievement of company and departmental goals and objectives. Has a strong working knowledge of the regulatory compliance requirements for the production of biologics used in clinical studies. Remains current regarding current Good Manufacturing Practices (cGMP) guidelines and develops and/or modifies production methods to fully address compliance issues. Demonstrates innovative technical knowledge and significantly contributes to the overall operations of the lab. Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation. Participates in manufacturing operations in assigned area per cGMPs. Analyzes scientific data with accuracy and precision, critical at time of processing.

• Interact with other Testing laboratories, Facilities, Validation, Quality Assurance, Project Management and Materials Management groups. As needed, further interaction will be required with material/equipment vendors and commercial partners.
• Responsible for activities required for successful operation of assigned project area including: ensuring batch production activities follow all documentation and Standard Operating Procedures (SOPs).
• Responsible for cGMP compliance for technicians
• Responsible for coordinating the training of new technicians on areas of technical expertise and compliance issues relevant to the lab setting.
• Responsible for scheduling and coordinating day-to-day laboratory operations.
• Contributes independently to overall scientific rigor through objective laboratory investigation.
• Cleans process suites and equipment.
• Reviews and signs logbooks.
• Communicates status of operations, safety and maintenance problems, in a timely manner to Area Management.
• Participates in internal meetings, client audits, and conference calls as appropriate.
• Monitors and communicates inventory needs to company’s Materials Management group.
• Initiates deviations/investigations as needed.
• Normally receives minimal instructions on routine work and detailed instructions on new assignments.
• Works under close supervision from supervisor or senior personnel.
• Ability to work in a team environment and independently as required
• Maybe required to work Holidays and weekends
• Contributes to the overall operations and to the achievement of departmental goals
• Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work
• Plans, monitors, and appraises direct reports including performance competencies, goals & job results
• Coaches, counsels, and conducts disciplinary actions
• Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards

Experience / Education
• HS Diploma or equivalent required and
• 5+ years relevant technical experience and min 2 years in a Lead/Leadership/Supervisory Role
• BS/BA in Science related field preferred; or combination of relevant Experience & Education

Knowledge / Skills / Abilities:
• Knowledge of protein based assays (i.e. ELISA, electrophoresis, etc), flow cytometry and/or cell based potency methods.
• Effective multi-tasking skills and time management required
• Ability to mentor technician level staff in the execution of their duties.
• Ability to use judgment as dictated by complexity of situations
• Ability to understand and follow verbal and demonstrated instructions
• Ability to clearly express and exchange ideas by means of detailed verbal and written communication
• Ability to work effectively as part of a team and exhibit effective interpersonal skills
• Ability to work under limited supervision and to handle problems of a difficult nature
• Proficient in Oral & Written communication skills

Physical Requirements:
• Must be able to work in Lab setting with Biohazards /various Chemicals
• Must be able to wear appropriate PPE.