Quality Control Supervisor
Location: Somerville, Massachusetts, 02143, United States
Finch Therapeutics is a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery platform to develop a novel class of orally administered biological drugs.
With the capabilities to develop both complete and targeted microbiome therapeutics, Finch is advancing a rich pipeline of candidates designed to address a wide range of unmet medical needs. Finch’s lead candidate, CP101, is in late-stage clinical development for recurrent C. difficile infection (CDI). In June 2020, Finch announced that CP101 met its primary efficacy endpoint in PRISM3, the first of two pivotal trials to support the development of CP101 for the prevention of recurrent CDI. Finch is also developing CP101 for chronic hepatitis B, and FIN-211 for autism spectrum disorder. In partnership with Takeda, Finch is advancing FIN-524 and FIN-525 for ulcerative colitis and Crohn’s disease, respectively.
The Quality Control (QC) Supervisor, with guidance from the Sr Manager of Quality Control, will support manufacturing activities by coordinating the reporting of lab-generated data as it pertains to lot release and stability studies at Finch. The QC Supervisor will both contribute to and iterate strategic planning initiatives regarding process improvements across all QC systems. This individual will communicate with professionalism and clarity both internally and across groups to support the integration of a company-wide understanding of Quality Control. Additionally, he/ she will focus on process improvement to the existing systems as well as executing on deviations, CC, CAPAs, invalid assays, and OOS results.
- Support a QC laboratory that routinely tests raw materials, in-process materials and final products in accordance with SOPs and applicable regulations
- Flow Cytometry
- Visual Appearance
- Environmental Monitoring
- Residual Moisture
- Pathogen Testing
- Schedule all testing activities of direct reports and ensure execution
- Coach and mentor staff in all aspect of their job performance and career development including training, feedback, rewards and disciplinary action.
- Coordinate testing with external laboratories and ensure adherence to release testing and timelines
- Manage QC related communications and relationships with CTOs
- Review executed test records and generate Certificate of Analysis (CoA).
- Ensure strong Quality program for management of equipment and computer systems to ensure proper maintenance, calibration and conformance to regulatory standards.
- Perform data analysis and trending of data in support of monitoring and method life-cycle programs
- Provide strategic technical guidance and support for all QC operations in relation to quality systems (e.g. change controls, CAPA, deviations, etc.)
- Support and perform when necessary routine testing of raw materials, in-process materials and final products in accordance with SOPs and applicable regulations
- Ensure that samples are processed in a timely manner
- Ensure log books related to inventory and equipment are maintained
- Ensure labs are clean and safe (in compliance with cGMP) and properly stocked
- Represent QC during operational lab audits
- Lead in writing and revising SOPs, Test Methods, and other technical documents
- Make detailed observations in support of Alert, Action and OOS result investigations
- Provide strategic /technical guidance and support for all operations and related quality systems (change controls, CAPA, deviations, etc.)
- Participate in writing and revising SOPs and Protocols
- Assist in regulatory submissions and responses
- Maintain a high level of personal compliance to the required standards
- Bachelor’s Degree in Biology, Chemistry or related sciences
- Preferred 7-10 years of relevant experience in a pharmaceutical testing laboratory
- Preferred candidate should have 2 years’ experience in managing staff
- Familiarity with relevant and current FDA, EU, ICH guidelines and regulations
- Good critical thinking, deductive reasoning, and decision-making skills
- Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way
- Demonstrated ability to work in a collaborative environment with positive interactions and a hands-on approach that emphasizes team work, collaboration, influencing, motivating, and consensus and team building
- Self-starter, detail-oriented, data-driven, and a team player
- Be flexible and excited to work in a fast-paced environment with evolving needs
Physical demands and work environment:
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to gown and gain entry to manufacturing areas
- Ability to work in a manufacturing clean room for an extended period of time
- Physical demands: While performing duties of job, employee is occasionally required to stand for extended periods of time as well as occasionally required to walk, sit, bend down/ crouch, use hands to handle or feel objects, tools, or controls; reach with hands and arms; talk and hear
- Employee must occasionally lift and/or move up to 30 pounds
More About Finch
Here at Finch, we strive to create the best work environment and experience for you through our formal benefits programs and fringe perks. Together, we hope that we’ll create a fun & supportive environment in and out of the workplace as we strive to create a new class of therapeutics together to help patients.
- Our formal benefits include medical, dental, and vision coverage through Harvard Pilgrim in addition to life insurance and long-term & short-term disability policies. We offer discretionary and flexible paid time off policies. Should you choose to start or grow your family while working at Finch, we aspire to lead our peers by offering several months of paid parental leave. We also offer a generous non-discretionary 401K contribution to help teammates save for life beyond Finch in the future and other savings and investment opportunities.
- We also try to keep the workplace an inspiring and motivating place to work with our fringe perks. Our facilities in Somerville, MA include an in-office gym with a shower and towel service (temporarily closed due to COVID), fully stocked kitchen with free snacks, iced coffee & flavored/sparkling waters on tap. We sponsor ride-sharing to and from the office from preset locations around Boston, Cambridge, and Somerville. We are always evaluating our fringe perks and hope to grow them alongside our team.
*Only facility-dependent employees are working on-site in Somerville until further notice.
Equal Opportunity Employer
We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. Finch will make reasonable accommodations for qualified individuals with disabilities, in accordance with applicable law.