Manager/Senior Manager, Quality Control - Microbiology

Manager/Senior Manager, Quality Control - Microbiology Lexington, Massachusetts The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. WORKING AT GENEZENManypeople have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. PURPOSEResponsible management of the Microbiology laboratory and personnel and execution of the site Environmental and Personnel Monitoring program. This individual is expected to have strong, hands‐on, and technical experience of microbiological assays (Endotoxin, Bioburden, TOC) and Environmental Monitoring. The Microbiology Manager ensures strict adherence to all cGMP/GMP policies and standard operating procedures, provides microbiology technical expertise, and communications effectively with other departments. The Manager will also have a proven track record with Continuous Improvement and be a champion for the change within the Microbiology team and the QC organization as a whole. ESSENTIAL JOB FUNCTIONS / DUTIESMaintain a safe, efficient, functional, and compliant laboratory operation in accordance with GMP SOP's, guidelines and regulations. Coordinate day-to-day management of QC Microbiology operations, including high-level planning of activities and resources, guidance/performance review within QC, and maintaining or initiating communication cross-functionally. Manage and develop the performance of direct reports by setting clear goals, providing performance feedback, supporting career development and recognizing and rewarding exceptional performance. Oversee testing in-process samples, drug substance and drug product release/stability and complaint samples. Oversee performance of environmental and utility monitoring according to SOP's, sample test requests, and per approved protocols and investigations. Maintain data integrity to the highest industry standards, Oversee timely investigation of OOS, OOT, and other laboratory exceptions, and timely management of Deviations, Change Controls, and CAPA, and maintenance of critical reagents, controls, and laboratory supplies. Manage outsourced testing activities as necessary and ensure results are reported in a timely and compliant fashion. Develop, maintain, and continuously improve robust QC systems to ensure compliance in sample management, testing, data approval, data management, data archiving, and validation and calibration of QC equipment. Engage with Continuous Improvement projects cross-functionally that support site improvements and cost efficiency. Support and participate in internal and external inspections and audits including regulatory inspections. Collaborate with QC Tech Services for method validation, specification generation, stability studies and support life cycle management of methods, Ref. Std. & Critical reagents. Support new equipment validation and implementation. Provide QC data internally and internally and actively support and participate in cross functional teams (CMC, Quality Management, Management Review Meetings, SRB etc.).Ensure timely issue escalation to Quality senior management and cross-functional support teams. SPECIAL JOB REQUIREMENTSAdaptability required as work schedule may change based on business needs Criminal background check and drug screen required Other duties as assignedKNOWLEDGE, SKILLS & EXPERIENCEEDUCATION / CERTIFICATIONS / LICENSESBS in Microbiology/ Biology, or related scientific disciplineON-THE-JOB EXPERIENCEAt least 8 years' GMP Quality Control experience with at least 4 years management experience Advanced knowledge of global, especially US and EU GMP guidelinesSKILLS / ABILITIESStrong leadership in team management, decision making, change management, collaboration, delivering desired business results, and ability to influence Confident, independent, self-starter, proactive, and results-oriented with high performance and compliance standards Strong ability to prioritize and operate with a sense of urgency Solid organizational, analytical and problem-solving skills Effective communication skills with the ability to interact with all levels of the key stakeholder with demonstrated interpersonal skills Demonstrated ability to effectively solve problems and implement practical solutions in a dynamic and innovative environment Strong operational and business acumen Exhibits highest integrity and committed to ethics and compliance standards Open and transparent in sharing data and informationCOMPENSATION RANGEThe compensation range for this position is dependent upon experience level of the successful candidate. The ranges are as follows: