Manufacturing Production Supervisor (Downstream)
Location: Somerville, Massachusetts, 02143, United States
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.
The Manufacturing Production Supervisor is responsible for day-to-day supervision and leadership to product-focused and product-specific manufacturing operations to meet product and quality demands of Finch Therapeutics, and to assure a safe, efficient, productive, and positive work environment for the assigned department. This position consistently directs, coaches, trains and gives performance feedback to the employees.
The hours are Monday – Thursday (10 Hour Days)
- Communicate to ensure that all understand the day’s production schedule, priorities, key issues, and challenges
- Build and develop an efficient team capable of consistently producing clinical product according to cGMP standards. Includes, hiring, orienting training, coaching of personnel, and leading group meetings.
- Ensure cGMP compliance through direct oversight of manufacturing staff and floor operations
- Provide support for Tech Transfer activities
- Review daily production documentation to minimize deviations
- Creates, revises, and reviews-controlled documents including SOP and batch records for manufacturing
- Author and support on time issuance and closure of Quality System related documentation such as deviations, CAPAs, change controls.
- Ensure production resources including materials, equipment, and people are available as needed to maintain production schedules
- Ensure employee training is maintained and in compliance with appropriate procedures, specifications, and standards.
- Actively engage in colleague development, including timely performance feedback/appraisals as well as through other aspects of the performance management process (i.e. 1:1s).
- Assists manager with special projects and other duties as assigned or needed
- Ability to multi-task, troubleshoot and knowing when to escalate
- Ability to see the “big picture” while being capable of driving detailed, tactical execution. A high sense of urgency and a commitment to delivering results is essential.
- Work independently with minimal supervision
- Must be able to work flexible hours
- Keep work environment clean, safe and positive
- Propose ideas and aids for improving team work environment
- BA/BS degree and/or relevant work experience
- 4+ years of relevant work experience in Production or Operations
- Lyophilization or Encapsulation experience is a plus
- Previous supervisory experience is a plus
- Excellent skills in multi-tasking and proactive thinking
- Microsoft Office Proficiency and other data analytics packages
- Strong writing and communication skills (Technical writing experience a plus)
- Ability to learn quickly and adjust approach to problems based on feedback
- Strong project management skills
- Highly detail-oriented and organized approach to work
- Ability to lift 40+ lbs
- Ability to stand for prolonged periods of time in full cleanroom gowning
- Must be legally eligible for work in the United States
- Ability to work Weekends and Holidays as needed.
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.