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.
Position Summary
The Manufacturing Specialist uses knowledge of compliance and GxP manufacturing processes to manage investigation and improvement initiatives within manufacturing operations.
Responsibilities
Manages cross functional team projects to drive complex investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action.
Utilizes manufacturing process knowledge and investigation skill sets 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 managers and supervisors to develop and maintain training materials and curricula on process operations, theory, and compliance.
Performs training with staff on the floor, as needed.
Leads cross-functional continuous improvement projects with Process Engineering, Validation, Quality Assurance, Quality Control, Facilities, Operations.
Works independently with minimal supervision and direction.
Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.
Creates and presents trending and metrics reports.
Qualifications
High school diploma/GED or Biotech Certification with 5-7 years of experience, or bachelor’s degree with 3–5 years of experience.
Minimum of 2 years’ experience with deviation/investigation management systems or a similar technical writing system
Subject matter expertise in biologics manufacturing Microbiology or a similar complex specialized environment.
Knowledge and demonstrated understanding of GxP or a similar complex specialized environment and understanding of how it applies to specific responsibilities and manufacturing operations.Experience authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents.
Excellent written and oral communication skills.
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.