We are a rapidly growing company that manufactures biologics to help accelerate scientific research and breakthroughs. We are seeking a Director, Quality Control to oversee all operational aspects of Aldevron's Quality Control function. This includes project management, method development and validation, raw data/protocol/report review, in-process and product release testing, stability programs, data trending, reference standards assay change control and compliance. This position will act as a subject matter expert with external clients and regulatory agencies on all QC matters. Qualified candidates will have:
* BS or MS in, Cell Biology, Molecular Biology, Biochemistry or a related discipline with 5-7 years industry experience. * Previous experience in managing a Quality Control department in biotech/pharmaceutical industry in a cGMP environment is required. * Experience developing and qualifying biological methods in one of the following areas: cell-based assays, qPCR assays, HPLC, and microbiological assays. * Experience implementing and maintaining departmental metrics * Prior experience working with external testing laboratories, preferred. * Experience drafting protocols, data reports and QC/QA compliance documents required.
About the Role
* Ensure Quality Control process, systems and daily work activities are conducted in compliance with SOPs and Regulations. * Conduct analyses of departmental activity costs, resources, and throughput data to determine progress toward stated goals and objectives and in support of providing COGs and assay pricing information to Finance upon request. * Work collaboratively with other site functions to ensure that analytical methods are aligned with process needs/capabilities and product requirements. * Keep up to date on new technologies, methodologies and changes in Standards * Represent Aldevron as the QC SME for analytical methodologies, specifications, stability studies, and reference standards with Clients and Regulatory Bodies, as required. * Identifies, evaluates and executes on process improvements to increase existing capabilities. * Ensure strong interaction with multiple groups to facilitate appropriate resource allocation and scheduling of in-process/release testing, outsourced testing, environmental monitoring and internal initiative projects. * Direct, review, and approve laboratory method validation protocols and laboratory equipment qualifications. * Assist with the interpretation of test results and to determine disposition or additional steps to be taken, as needed. * Provide GMP QC guidance and oversight to support programs including but not limited to assay development, technical transfer, method validation and routine GMP testing (lot release and stability testing). * Provide technical support, including internal method development, testing and troubleshooting, stability study report authoring and/or review and CMC support as needed. * Support QC deviations, investigations, analytical method performance trending and work with external testing laboratories on investigation actions and root cause analysis. Ensures thorough investigations are performed leading to the assignment of root causes and the implementation of effective corrective/preventive actions (CAPA) to minimize the possibility of recurrence. * Direct the generation and implementation of performance and training programs for Quality Control personnel. * Hire, train, motivate, lead, develop and evaluate staff assigned to the department, facilitating and assisting in their growth within Aldevron. * Establish goals, objectives and measures to drive continuous improvement of the QC operations. * Ensure that departmental performance adheres to established performance metrics. Ensures departmental tasks are completed by their established target dates. * Embrace the concept of Continuous Improvement in efficiency and productivity. * Oversee QC activities, including the review and approval of test records/forms, final reports, Standard Operating Procedures (SOPs) and CofAs. * Ensure drafting and periodic review of SOPs, records/forms and protocols for in-house QC testing and overall QC operations. * Facilitate the evaluation of new testing applications and instrumentation. Prepare justification for new lab equipment, prepare purchase orders and coordinate authorization and procurement. * Manages process optimization that includes continual improvement programs for analyses, personnel development, equipment and data management systems. * Overall responsible for environmental monitoring program, including personnel training on critical sampling techniques, ensuring weekly monitoring and reporting is conducted and generating Impact Risk Assessments and quarterly/annual reports. * Review and approval of Project Order Specifications, as related to QC activities, and internal communications to obtain additional details as necessary. * Assess vendor change notifications from contract laboratories to determine impact to Aldevron. * Take lead responsibility with contract laboratories supporting outsourced testing, method development and assay validation activities. * Perform review and approval of QC department related QA internal audit reports. * Generate department metrics to support Site Operations and Quality System Management Review and as otherwise requested.
Why Join Aldevron?
* You want meaningful work. We are in a landmark moment in the history of life science, and Aldevron is at the center of it. * You want to plant your career in a growing company. We are growing fast. We have limitless opportunities for people who are ready to roll up their sleeves and jump in. * You are excited to learn every day. At Aldevron, no day is the same. Our team comes to work ready to learn and overcome new challenges with teamwork and a passion to make lives better.
Your talents, ideas, and passion are essential to our success. Join us today!