This is an exciting time to be joining Argos Therapeutics, an RTP-based biopharmaceutical company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases. This is a critical time for the Quality function to help drive the company’s growth and expansion as we near the end of our first phase 3 clinical trial and prepare for regulatory filing and ultimately commercial launch of the first Argos product. This critical role will oversee the QC microbiology analysts performing environmental monitoring, and other microbiology testing in support of aseptic manufacturing processes.
- Manage the timely interpretation of testing results and trending of data to ensure conformity with quality specifications, including review of assay performance to ensure methods and results are as expected.
- Oversee testing of materials, components, personnel and the environment to detect microorganisms and to obtain information on types and levels of microbial contamination.
- Determine impact of microorganisms on processes/products and evaluate the effectiveness of microbial control strategies on the manufacturing environment.
- Oversee the development, implementation, or tech transfer of microbial methods for testing and release of in–process, and release testing for biological products and reference materials.
- Provide a motivating environment that support employees performing at their best. Sets clear expectations, monitors performance, coaches, counsels and motivates. Has responsibility for hiring, goal setting, performance evaluations, etc.
- Assist with the development and management of the departmental budget and setting of short- and long-term department goals. Collaborate with the Method Validation group for the execution of methods, tech transfers and assay validations.
- Manage environmental and microbiology program enhancements and continuous improvement efforts.
- Manage trending of environmental and microbial data and the preparation of testing protocols and reports.
- Oversee and ensure that the QC department carries out testing functions including routine and non-routine analysis of raw materials, in process testing, and finished products, in a timely and efficient manner to support the GMP manufacturing process and the Process Development groups (as required).
- Assist on initiatives to improve QC processes, cost effectiveness, enhancing efficiencies, safety and compliance of processes and procedures within current regulatory standards.
- Ensures testing is in accordance with SOP’s and regulatory requirements
- Provides oversight for GMP activities including document management of QC procedures, review of investigations, deviations, change control, and environmental monitoring program.
- Ensure department training compliance in all aspects of testing, cGMPs, SOPs, company policies and safety policies.
- Work cooperatively with other departments, including Manufacturing, Research/Development and Quality Assurance.
- Oversee staff development, managing resources, mentoring, coaching and counseling staff.
- Participates during audits conducted by regulatory agencies representatives to provide information and handle questions and/or concerns.
- When the company is in height of commercial manufacturing, if a second shift is added, this position will be responsible for overall direction of the QC teams for all shift.
- Other duties as required. Occasional weekend work (Saturday and/or Sunday) will be required.
- B.S. or M.S. Degree in a scientific discipline.
- Seven (7) to Ten (10 years) microbiologist recent experience in an FDA-regulated pharmaceutical manufacturing environment with a minimum of five years direct experience managing a Microbiology QC group in a cGMP environment.
- Experience overseeing the microbial quality control function at a biologics GMP manufacturing facility is required. Commercial product experience in Quality Control is desirable.
- In-depth knowledge of all quality control functions and responsibilities, lot release responsibility, investigations, and FDA manufacturing requirements.
- Experience with receipt of raw materials and finished product testing according to USP and other validated methods.
- Demonstrated ability to manage, motivate and mentor scientific personnel and encourage teamwork among functional groups in Operations, Process Development and R&D.
- Role model of collaboration with ability and willingness to work in a team environment.
- Strong verbal, written and interpersonal communication skills are essential.
- Excellent scientific analysis and interpretation skills as well as problem solving skills.
- Results oriented with a track record of delivering highest quality work product exceeding or consistently meeting established timelines and instilling a high performance work ethic among the team being supervised.
- Track record of accountability, sense of urgency, flexibility and adaptability.