Role Description
We are a stealth-mode life sciences startup seeking a hands-on Quality Control Analyst to help build and advance our cell therapy manufacturing and quality control capabilities. This is a unique opportunity to contribute to the development of analytical methods, and quality systems that that will support our programs from early development through Phase 2 clinical studies and beyond.
In this highly collaborative role, you will contribute to process development, quality science, analytical development, and clinical translation, You will help develop and execute analytical testing strategies, establish scalable QC processes, and generate high-quality data that ensure product quality and process control throughout the manufacturing lifecycle. Working closely with Process Development, Bioanalytical, Quality Assurance, and external manufacturing partners, you will play a critical role in advancing innovative cell therapies toward the clinic.
This position is ideal for a scientist who enjoys hands-on laboratory work, solving complex technical challenges, and building scalable processes in a fast-paced startup environment. If you're energized by high-impact science at the intersection of biology, engineering, and clinical translation, and are excited to help build something from the ground up, we’d love to hear from you!
Key Responsibilities
QC Method Development & Qualification
- Serve as a key in-lab contributor for qualifying analytical methods that support GMP manufacturing and clinical lot release.
- Execute and support the design of well-controlled method development, optimization, and qualification/validation studies for potency, purity, identity, and safety attributes.
- Qualify critical process analytics and release assays, including cell-based potency assays, flow cytometry panels, ELISA, qPCR, and imaging-based analyses relevant to ocular cell therapy products.
- Author and review method protocols, validation reports, SOPs, specifications, and Certificates of Analysis (CoAs) in compliance with GMP documentation standards.
- Maintain accurate and detailed records of all experimental plans, raw data, and analytical documentation.
QC Testing, Lot Release & Stability
- Perform and/or oversee in-process, release, and stability testing of clinical-phase materials manufactured internally and through external partners.
- Review and approve QC data packages and lot release documentation for clinical manufacturing programs.
- Design and manage stability studies, including tracking, trending, and reporting to inform shelf-life strategy and regulatory submissions.
- Identify out-of-trend (OOT) or out-of-specification (OOS) results; lead investigations including root cause analysis and CAPA development.
Analytics, Data Integrity & Reporting
- Apply statistical tools and data analytics to evaluate method performance, trending, and process control data across manufacturing campaigns.
- Author and contribute to CMC sections of regulatory submissions, including analytical methods, specifications, and QC data summaries.
- Ensure QC data systems align with applicable data integrity requirements, including 21 CFR Part 11 expectations.
- Collaborate with external CMOs and contract testing laboratories; represent QC in technical meetings, conduct method transfers, and perform on-site oversight visits as needed.
Qualifications:
- Master’s or Bachelor’s degree in cell biology, biochemistry, analytical chemistry, pharmaceutical sciences, or a related scientific discipline
- Minimum 3 years of hands-on experience in analytical method development and qualification for cell therapy, biologics, or gene therapy products.
- Proficiency with assay platforms relevant to cell therapy QC; flow cytometry, cell-based potency assays, qPCR, ELISA, microscopy, and/or imaging analysis.
- Demonstrated ability to design experiments, analyze complex datasets, and translate findings into actionable QC decisions.
- Working knowledge of ICH guidelines and FDA/EMA expectations for advanced therapy medicinal products.
- Ability to work independently while collaborating effectively across scientific and technical teams
Preferred Experience or Qualifications:
- 3+ years of biotech or pharmaceutical experience, with a strong preference for cell therapy or biologics manufacturing environments.
- Experience in ocular biologics or ophthalmic cell therapy programs.
- Experience developing or executing QC programs for iPSC-derived or primary cell therapy products.
- Familiarity with GMP documentation practices, including SOPs, batch records, specifications and deviation/CAPA reporting.
- Familiarity with automated imaging workflows or high-content analysis platforms for cell characterization.
- Experience applying Design of Experiments (DoE) methodology to method optimization or process analytics.
- Experience with tech transfer of analytical methods from research-grade to GMP-grade environments.
- Proficiency with statistical software (e.g. JMP, Minitab) for QC data trending and method validation analysis.
- Familiarity with electronic quality management systems (e.g. Veeva, MasterControl) and 21 CFR Part 11 compliance.
Why Join Us
As an early member of our team, you will have the opportunity to directly influence the development of innovative cell therapy technologies and help establish the quality foundation of a growing biotechnology company. Your work will play a critical role in advancing programs toward clinical milestones while collaborating with a team of scientists and innovators committed to making a meaningful impact for patients.
The annual base salary we expect to pay is $78,000-$100,000. Individual pay decision depends on various factors such as responsibility of role, job duties/requirements, and relevant experience and skills.
We are an equal opportunity employer.
We do not discriminate on the basis of race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.
Pay: $78,000.00 - $100,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Vision insurance
Work Location: In person
