open positions

Manufacturing Specialist

Location: Somerville, Massachusetts, 02143, United States
Full-time

About Finch

Finch is unlocking the therapeutic potential of the microbiome via a human-first drug discovery platform. We support clinical studies that intentionally manipulate the microbiome to investigate causality in diseases that are otherwise poorly understood. Using high-throughput molecular data from clinical studies and ex-vivo experiments, we identify specific strains that drive clinical phenotypes and responses to microbial therapies. Our team values transparency, integrity, humility, and collaboration, and we intend to have fun while maximizing our ability to make an impact on patients’ lives. We are searching for passionate teammates eager to support this mission.

At Finch, you can expect to engage deeply in the core of our mission. You will grow with a dynamic, rapidly expanding organization, and have an opportunity to contribute to cutting edge research that will truly impact patients’ lives. We offer a competitive compensation package plus healthcare and other benefits. As we grow, there will be opportunities for promotion and professional development.

 

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

 

Requires Skills/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 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.