Quality Control Director Argos Therapeutics
ARGOS IS GROWING!
After having met several important milestones including exciting clinical data, we are poised for new strategic objectives which will require significant new resources. Those new resources include a well-qualified Quality Control Director.
The Quality Control Director will be responsible for management of the Quality Control group and oversee the development, implementation and maintenance of quality control systems to ensure compliance with GMP regulatory requirements for cell based therapies. The Director will also establish objectives for the group and work with senior management on managing the QC activities necessary to prepare Argos products for licensing.
Direct the development, implementation, or tech transfer of all methods for testing and release of in ?process, and release testing for biological products and reference materials.
Directs timely interpretation of testing results and trending of data to ensure conformity with quality specifications, including review of assay performance; and works with R&D as needed to ensure methods and results are as expected.
Direct all QC assay validations including working with R&D to establish critical and optimized methods, followed by method validation protocol development, execution and generation of final reports ready for submission to regulatory authorities
Develop and manage the departmental budget and setting of short- and long-term department goals.
Direct the development and testing programs for raw material specifications, compliance and testing verification program.
Manage initiatives to improve QC processes, cost effectiveness, enhancing efficiencies, safety and compliance of processes and procedures within current regulatory standards.
Direct and ensure that the QC department carries out testing functions including routine and non-routine analysis of raw materials, in process testing, and finished cellular products, in a timely and efficient manner to support the GMP manufacturing process and the R&D group.
Ensures testing is in accordance with SOP?s and regulatory requirements.
Directs timely preparation of testing protocols and reports that are scientifically supported and in compliance with 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.
Selects, develops and evaluates QC personnel; directs QC organizational development, managing resources, mentoring, coaching and counseling and managing performance and compensation processes for the department. Emphasize team building approach.
Represent the QC laboratory during audits conducted by regulatory agency representatives to provide information and handle questions and/or concerns.
Other duties as required.
B.S. or M.S. Degree (PhD preferred) in a scientific discipline, preferably biology or chemistry, and 10 years relevant biologics industry experience in a cGMP environment.
Experience overseeing the quality control and assay validation function at a biologics GMP manufacturing facility is required. Commercial product experience in Quality Control is desirable.
Experience in the development of cellular vaccines desired, including experience in flow cytometry cell counting, and RNA gel electropheresis.
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 Manufacturing.
Ability and willingness work in a team environment.
Strong verbal and written communication skills are essential.
Excellent scientific analysis and interpretation skills as well as problem solving skills.
We offer a competitive compensation package along with outstanding benefits. For confidential consideration, please submit a resume with a cover letter and salary history.
No phone calls please.
||4233 Technology Drive |
Durham, NC 27704