Director, Quality Control

Company: Finch Therapeutics
Location: Somerville
Posted on: September 17, 2020

Job Description:

Somerville, Massachusetts, United States | Quality | Full-time

Finch is a clinical-stage company developing novel microbiome drugs to serve patients with serious unmet medical needs. Our machine learning-based platform mines molecular data collected from human interventional studies to identify the microbial communities driving positive patient outcomes in different disease areas. By developing drugs from microbial communities that have already demonstrated therapeutic effects in humans, we are pioneering a new approach to drug discovery and rapidly transforming the promise of the microbiome into a reality for patients.

Our lead therapeutic candidate, CP101, is initially targeting the prevention of recurrent C. difficile infection (CDI). CP101 recently met its primary endpoint in a large placebo-controlled trial in recurrent CDI, providing the first positive pivotal data for an oral microbiome drug. We also have programs targeting the treatment of chronic hepatitis B, children with autism and serious GI symptoms, as well as two programs partnered with Takeda Pharmaceuticals targeting inflammatory bowel disease.

Position Summary

The Quality Control (QC) Director will be responsible for the managerial, technical, operational and strategic leadership in the development, continuous improvement, and implementation of cGMP Laboratory System. Provides leadership and functional subject matter expertise in these key areas: Donor Program, Raw Materials, Microbiology, Stability, and cGMP release testing. This role requires full collaboration with internal and external teams in analytical development, manufacturing, quality assurance and regulatory affairs. Fosters a quality and continuous improvement mindset to ensure that all QC deliverables are cGMP compliant in a phase-appropriate manner to support early and late phase clinical programs. In addition, this role will manage a new laboratory space that’s under construction as part of a new cGMP commercial manufacturing facility, and will provide QC support in facility commissioning and qualification.

Responsibilities / Duties

Provide leadership for the Quality Control function through development and implementation of the overall QC strategic plan.

Plan, develop and manage QC departmental budget

Engage with Analytical Development (AD) and Quality Assurance to build a sustainable cGMP QC platform to support growing portfolio of clinical development programs. This includes ensuring harmonized approach to method development with AD that supports the transition and implementation of methods fit for commercial QC.

Oversee method transfer, validation, testing and investigation for multiple microbiota product portfolio. This includes assessment for QC fitness of newly transferred methods from AD as well as contract/partner organizations.

Develop phase-appropriate QC capabilities, business processes, and procedures to ensure robust product supply, including establishment of appropriate processes for specifications setting and holistic control strategy.

Promote a culture of safety, quality and accountability mindset, including continuous improvement through the establishment of KPI metrics

Manage internal and external cGMP labs by reviewing and approving specifications and documents as required, including SOPs, protocols, reports, test methods, change requests, tech transfers and investigations.

Ensure that raw material, in-process and final release testing is accurate and timely.

Oversee stability programs to support both clinical and commercial products.

Maintain current knowledge base of regulations, especially for the Donor Program, and industry best practices, trends, and standards to ensure that the QC function and the laboratory quality control system remain in compliance with applicable company requirements and global regulations.

Develop, hire and provide team leadership, including creating development plans. Establish continuous learning and improvement programs, thereby ensuring all team members are engaged and passionate about their work.

Other duties may be required

Qualifications

BS, MS, or PhD in Microbiology, Molecular Biology, Biochemistry or other relevant scientific field of study with at least 10 years of pharmaceutical/biotechnology industry experience; advanced degree is preferred

Early to late clinical stage and commercial cGMP and CMC experience

Established experience working with and management of third party contractors and vendors

Proven leadership experience and people management skills

Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution

Ability and desire to work in a fast-paced and dynamic environment that will require management of several competing priorities while driving projects forward and meeting program/project deliverables Strong collaboration, team-building, and written and oral communication skills

Independently motivated and detail-oriented with stellar problem-solving ability

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 a 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.

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.

Keywords: Finch Therapeutics, Somerville , Director, Quality Control, Other , Somerville, Massachusetts