QA/QC Lead MarvelBiome Woburn, MA Job Details Full-time $125,000 - $150,000 a year 21 hours ago Benefits Health insurance Dental insurance Paid time off Vision insurance Qualifications FDA submissions Biotechnology GMP ICH guidelines Clinical research compliance Bachelor's degree Pharmaceutical company experience Quality assurance experience within pharmaceutical industry Chemistry, manufacturing & controls Regulatory submission editing and review Communication with regulatory authorities for clinical trials Quality control experience within pharmaceutical industry Clinical quality assurance standards Quality audits Cross-functional communication Pharmaceutical manufacturing facility experience Full Job Description About MarvelBiome MarvelBiome, Inc. is a clinical-stage biopharmaceutical company with a vision to harness the power of microbes to treat a range of human diseases. The company is founded over years of advanced scientific research conducted by the co-founders at Massachusetts General Hospital/Harvard University, Boston, MA, including one co-founder who is a recipient of 2024 Nobel Prize in Medicine. About the Job We are seeking a QA/QC lead to support MarvelBiome's quality function at a pivotal stage of growth. This individual will be responsible for managing day-to-day GxP quality systems across development and manufacturing, ensuring compliance as we advance into Phase 2 clinical trials. As a key member of the quality team, the QA/QC lead will work closely with internal teams and external CDMOs to execute quality-related activities and ensure all operations meet regulatory and company standards. This is a hands-on role ideal for someone who thrives in a fast-paced, startup environment and is excited to contribute to the quality foundation for innovative microbiome-based therapeutics. Responsibilities Utilize expertise in Quality Management Systems (QMS) to review and interpret data from

CDMO QMS.

Guide internal teams in producing QMS-ready quality documents from process development outputs. Manage day-to-day Quality Assurance and Quality Control functions, including operational oversight of microbiome-based drug substance and drug product manufacturing. Act as a key quality contact for CDMOs, contract laboratories, and other external partners, ensuring adherence to quality agreements. Review and approve GMP documentation, including batch records, deviations, CAPAs, change controls, and investigation reports. Support the execution of QC strategies, including the review of data for analytical method qualification/validation, microbiological testing, and product characterization relevant to microbiome therapeutics. Contribute to regulatory filings (e.g., IND amendments, briefing packages) by authoring, reviewing, and compiling quality-related documentation. Participate in and support internal and external audits (GMP/GCP), including CDMO audits, and assist in driving remediation efforts. Collaborate closely with CMC, Clinical, and Regulatory teams to ensure quality activities are aligned with overall development plans. Identify and escalate quality and compliance risks across the supply chain and development lifecycle. Qualification Bachelor's or Master's degree in a scientific discipline. 5-8+ years of experience in Quality Assurance and/or Quality Control within the biotechnology or pharmaceutical industry. Strong experience supporting GMP manufacturing; experience with live biotherapeutics (LBPs) or biologics is highly desirable. Demonstrated experience working with CDMOs and managing outsourced manufacturing and testing activities. Thorough knowledge of FDA, EMA, and ICH guidelines related to GxP compliance. Experience supporting early-stage clinical development, including contributions to regulatory submissions. Familiarity with microbiome-based therapeutics or live microbial products is highly preferred. Excellent communication, organizational, and cross-functional collaboration skills. Ability to operate effectively in a fast-paced, startup environment and contribute to establishing robust quality processes. Compensation The base salary range reflects our current estimate for this position. Actual compensation will be determined based on factors such as job‑related skills, relevant experience, education or training, internal equity, and market conditions. This position is also eligible for equity compensation and a benefits package. Per Year Salary Range $125,000 - $150,000 USD, plus

Equity Job Type:

Full-time Pay:

$125,000.00 - $150,000.00 per year

Benefits:

Dental insurance Health insurance Paid time off Vision insurance Application Question(s): Do you now, or will you in the future, require sponsorship for a work visa? (e.g. H1B, OPT, etc.) Ability to

Commute:

Woburn, MA 01801 (Required)

Work Location:

In person