Senior Quality Control Analyst
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 Senior Quality Control Analyst is responsible for coordinating phase appropriate, GMP compliant Quality Control testing in support of clinical trials and ensuring continual quality improvement. The testing includes raw material, in-process, and final product release testing, as well as Drug Substance (DS) and Drug Product (DP) Stability testing. This individual provides leadership, subject matter expertise, and project management to QC. This individual will also be a mentor to junior analysts. The individual will be expected to use their experience to drive analytical qualifications, validations, process improvements, and quality issues (deviations, out of specification, invalid assay, etc). This position will require less management oversite as the induvial will be an experienced self-starter.
- Responsible for reviewing QC-testing deviations, investigations, OOS, CAPAs and invalid assays
- Support manufacturing activities through routine testing of materials
- Ensures QC testing and sampling activities are completed to meet quality and business requirements
- Responsible for continual process improvements in QC
- Ensures QC decisions align with Quality System, GMP, and Regulatory requirements
- Provides subject matter expertise on cross-functional teams
- Authors, reviews and/or approves reports, protocols, and data summaries
- Maintains a high level of personal compliance to the required standards
- Exercises professional written and verbal communications skills in supporting customer and team member needs
- Complies with all Quality System and GMP/GDP requirements
- Maintains training in accordance with all applicable SOPs and Regulatory Requirements
- Trains employees on analytical methods
- Other duties as assigned
- Bachelor’s degree in microbiology, or equivalent scientific degree
- 6+ years experience in a QC and cGMP environment.
- Experience with a broad range of bio-analytical and/or microbiological techniques such as DNA/RNA isolation, DNA quantification, qPCR, Flow Cytometry, cell viability, microbiological identification, ELISA, residual protein analysis
- Thorough knowledge of GMP and industry standards related to Quality Control with the ability to explain to junior peers
- Experience with ICH/FDA Stability testing requirements
- Experience with data trending and statistical analysis
- Strong written and oral communication skills
- Ability to identify aberrant data and potential quality/compliance concerns escalating to management
- Well organized, solid multitask abilities and must be able to perform under pressure/meet deadlines
- Proficient in MS Office applications
- Ability to work independently, with minimal supervision
- Experience with method transfer, qualification, and validation (preferred)
Physical demands and work environment:
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to gown and gain entry to manufacturing areas
- Ability to work in a manufacturing clean room for an extended period of time
- Physical demands: While performing duties of job, employee is occasionally required to stand for extended periods of time as well as occasionally required to walk, sit, bend down/ crouch, use hands to handle or feel objects, tools, or controls; reach with hands and arms; talk and hear
- Employee must occasionally lift and/or move up to 30 pounds
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.