[Senior] Donor Operations Specialist

About Finch  

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. 

 

Position Summary 

The Senior Donor Operations Associate will be responsible for assisting in the development of systems and procedures for the Stool Donor Program, investigating and responding to quality events and nonconformities, and coaching Donor Operations Associates. Additionally, this role will function to ensure that Donor Operations meets company, local, state, and national regulatory standards to comply with GCP, IRB, FDA, ICH, Finch QA, and MA Department of Public Health standards. 

 

Responsibilities / Duties 

• Serve as liaison with Quality Assurance to meet company and regulatory standards
• Author and Revise SOPs.  Manage and track SOP development, training and implementation in MasterControl
• Serve as lead investigator for quality deviations and nonconformities in Donor Operations 
• Initiate or assist in the generation of CAPAs
• Assist in developing and improving systems for GxP activities in Donor Operations 
• Ensure compliance with Donor Management Quality Standard, and update as needed
• Maintain controlled documentation (donor records, SOPs, regulatory filings)
• Assist in maintaining the integrity of all electronic and hard copy donor records
• Aid in coaching of junior Donor Operation Associates
• Help identify pain points and implement improvements to current processes

 

Qualifications  

• 5-7 years of professional experience with 4+ years of experience with deviation/investigation management
• Knowledge and demonstrated understanding of cGMP, GDP as it relates to production of pharmaceuticals
• Experience authoring and reviewing SOPs
• Experience performing on-the-job-trainings 
• Interest in building systems and problem solving
• Strong verbal and written communication
• Experience managing and tracking projects
• Exceptional attention to detail and ability to multi-task
• MasterControl experience a plus
• Proficient in Microsoft Office programs

 

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, 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.

*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.

 

 

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