Senior Validation Manager
Location: Somerville, Massachusetts, 02143, United States
Finch is a clinical-stage company developing novel microbiome drugs to serve patients with serious unmet medical needs. Our machine learning-based platform mines molecular data collected from human interventional studies to identify the microbial communities driving positive patient outcomes in different disease areas. By developing drugs from microbial communities that have already demonstrated therapeutic effects in humans, we are pioneering a new approach to drug discovery and rapidly transforming the promise of the microbiome into a reality for patients.
Our lead therapeutic candidate, CP101, is initially targeting the prevention of recurrent C. difficile infection (CDI). CP101 recently met its primary endpoint in a large placebo-controlled trial in recurrent CDI, providing the first positive pivotal data for an oral microbiome drug. We also have programs targeting the treatment of chronic hepatitis B, children with autism and serious GI symptoms, as well as two programs partnered with Takeda Pharmaceuticals targeting inflammatory bowel disease.
The Senior Validation Manager is within the CMC organization plans and oversees equipment, utility, cleaning, sterilization, software, and process validation activities to ensure compliance with company procedures and industry standards in support of Chemistry Manufacturing Control (CMC) Operations and Quality for Microbiome therapies. The Senior Validation Manager will also perform project coordination, vendor selection and management for contracted validation activities in support of new facility implementation and ongoing operations.
Responsibilities / Duties
- Perform validation activities including Master plans, protocol development, execution, failure investigations, analysis, and reporting.
- Coordinate completion of associated risk analysis and assessments as required for validation activities.
- Develop Standard Operating Procedures (SOPs), User Requirement Specifications, and other regulatory support documentation.
- Coordinate identification and scheduling of validation activities in support of key CMC projects.
- Select and manage vendors for validation support in alignment with Quality Supplier Management standards.
- Develop and manage a compliant equipment calibration program
- Identify and procure validation instrumentation and equipment as required.
- Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, and controls support projects.
- Train and manage personnel to assist in execution and reporting of validation studies
- Ability to act as system and process owner in conducting root cause analysis, deviation resolution (CAPA), and effectiveness checks.
- Minimum of Bachelor’s Degree (or international equivalent), preferably in Life Sciences or Engineering
- 7 to 10 years of professional experience in GMP operations with 5 years of relevant validation experience.
- Prior experience with Facility, Equipment and Utility Validation
- Ability to interact positively and effectively with other departments within the organization such as QA, Manufacturing, Regulatory, QC and senior leadership.
- Ability to develop and maintain effective relationships with various external vendors.
- Ability to adapt quickly to changing priorities and projects
- Ability to work independently on assigned projects with minimal supervision
- High level of attention to detail and organization.
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 Blue Cross Blue Shield 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, fully stocked kitchen with free snacks, iced coffee & flavored/sparkling waters on tap, and highly subsidized meals through LeanBox. 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.
*Though only facility-dependent employees are currently working onsite in Somerville, Ma, we all plan to return to the office when it’s safe to do so.
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.