Location: Somerville, Massachusetts, 02143, United States
Full-time
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.
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Position Summary
We are looking for an innovative individual with excitement for continuous change and a range of Manufacturing and Quality experience, who is self-starting and works well independently. This individual will have a high amount of visibility and will be working closely with Management of GMP manufacturing and Product Development groups to create internal manufacturing team practices for incoming members. In this role you will serve as subject matter expert within the manufacturing department and use knowledge of compliance and GMP manufacturing processes to support and manage ongoing tech transfer activities for internal GMP manufacturing. You will be a representative for manufacturing within many critical meetings including facility design. You will actively participate in problem identification, problem solving, change initiative, and process improvements.
Responsibilities
Supports cross-functional team projects to drive complex investigation close-outs, determine root cause and implement appropriate Corrective and Preventative Action
Utilizes extensive manufacturing process knowledge and investigation skillsets to identify and resolve manufacturing issues, improve process operations and affect positive change
Conducts complex document revisions and/or document management, including batch production records, manufacturing procedures, and cross-functional procedures
Works with manufacturing manager and supervisors to develop and maintain training materials and curricula on process operations, theory, and compliance
Demonstrates strong technical skills; provides technical assistance to area management to solve complex problems.
Performs training with staff on the floor and participate in some production runs, as needed
Reviewing and approving manufacturing batch records, SOPs, and other batch related documentation
Provide technical expertise and leadership in the absence of management
Leads cross-functional continuous improvement projects with Process Engineering, Validation, Quality Assurance, Quality Control, and Facilities Operations
Manage individual projects, including managing timelines and leading small group meetings
Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion
Creates and presents trending and metrics reports
Perform any other tasks/duties as assigned by Manufacturing Management
Qualifications
High school diploma/GED or Biotech Certification with 5-7 years of relevant experience, or Bachelor’s degree with 4 years of experience
Self Starting and high sense of urgency in the completion of tasks, with little to no supervision
Knowledge and demonstrated understanding of cGMP ,GDP as it relates to production of pharmacueticlas
Minimum of 4 years’ experience with deviation/investigation management for production related events and deviations.
Experience authoring and reviewing SOP’s and other controlled documents
Experience performing on-the-job-trainings for production personnel , as well as vendors and maintenance personnel
Excellent written and oral communication skills
Very strong organization and time management skills.
Attention to detail
Ability to assist and manage projects of varying complexity.
Strong team player
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, 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.