Description
Location: Boston, MA (On-site)
Reports to: VP of Manufacturing (with close collaboration of VP Quality)
Employment Type: Full-time, on-site
Compensation: Competitive salary and benefits, commensurate with experience and role level
About the Role
Boston Cell Standards is seeking a senior-level Diagnostics Manufacturing Scientist to join our growing company as we prepare for commercial launch. This role requires the ability and interest for bench-level work combined with strong practical experience operating within and supporting a regulated Quality Management System (QMS).
At the outset, this is a hands-on, bench-intensive role with direct responsibility for executing and mastering proprietary manufacturing processes within our ISO 13485–compliant quality system. Success requires comfort following detailed work instructions, generating and interpreting data, and producing precise, high-quality documentation. This initial phase is intended to build expertise in our proprietary manufacturing processes. It is a foundation for subsequent job scope.
Because our VP of Quality is part-time and remote, we are seeking someone who can also serve as a strong on-site partner in supporting day-to-day QMS processes within manufacturing operations. This role does not replace or supersede Quality leadership, but it does require maturity, judgment, and confidence working within regulated systems and ensuring that manufacturing documentation and execution meet quality standards.
Over time, as technical mastery and judgment are demonstrated, the role is expected to expand into broader scientific and manufacturing leadership responsibilities, including validation strategy, product expansion, manufacturing scale-up, and clinical implementation support.
About the Company
Boston Cell Standards developed the first system of reference materials to standardize the $3B immunohistochemistry (IHC) market—an area with the highest error rates in laboratory diagnostics (10–30%). Our platform introduces foundational principles of laboratory medicine to IHC, including reference materials, units of measure, and statistical process control. Our technology has been developed and validated over more than a decade through peer-reviewed research and international collaborations.
Key Responsibilities
1. Full-Time Hands-On Manufacturing & Technical Mastery
Execute proprietary manufacturing processes at the laboratory bench within an ISO 13485–compliant quality system.
Develop deep technical expertise in product formulation, process controls, and critical quality attributes.
Identify and troubleshoot manufacturing and process issues using data-driven, scientific approaches.
Generate, analyze, and document manufacturing data with strong emphasis on traceability, reproducibility, and compliance.
2. On-Site QMS Execution & Documentation Excellence
Operate confidently and independently within an ISO 13485–compliant Quality Management System.
Author, revise, and maintain SOPs, work instructions, batch records, validation protocols, and technical documentation, as needed.
Support implementation of change control and nonconformance processes in collaboration with Quality leadership.
Partner closely with the VP of Quality to ensure effective on-site execution of quality policies and procedures.
Note: This role supports Quality processes and documentation execution but does not hold final authority for audit oversight or overall QMS governance.
3. Product Expansion & Validation (Growing Scope)
Design, analyze, and interpret experimental studies supporting product expansion and regulatory certification.
Author and review validation reports and technical documentation.
Contribute scientific expertise to product and process scale-up activities.
4. Cross-Functional Collaboration
Work closely with Manufacturing, Quality, and Regulatory colleagues to implement product and process improvements.
Participate in technical discussions related to regulatory submissions and commercial manufacturing readiness.
Contribute to building scalable and durable manufacturing processes as the company grows.
Working Style and Mindset
Systems-oriented thinker who integrates scientific rigor with disciplined documentation.
Takes ownership of technical and operational problems and defines practical paths forward.
Comfortable working within structured, document-controlled environments.
Holds a high personal standard for accuracy, reproducibility, and compliance.
Thrives in early-stage environments that require both precision and adaptability.
Requirements
Education
PhD in Life Sciences, Chemistry, Biochemistry, Molecular Biology, or related discipline
OR
Master’s degree in a relevant scientific discipline with significant experience in regulated manufacturing and ISO 13485–compliant Quality Management Systems.
Experience & Capabilities
Genuine interest in sustained hands-on technical work at the laboratory bench and developing deep process expertise.
Demonstrated hands-on experience working within ISO 13485 or comparable regulated quality systems (medical device or diagnostics environment strongly preferred).
Practical experience authoring and maintaining controlled documentation (SOPs, batch records, validation protocols, reports).
Working knowledge of change control, nonconformance handling, and document control processes.
Strong experimental design, data analysis, and scientific writing skills.
Detail-oriented, methodical, and comfortable with structured technical systems.
Strong English communication skills, both verbal and written.
Collaborative, adaptable, and motivated to work in a fast-paced, growing company.
Why Join Us
Be part of a mission-driven company transforming cancer diagnostic testing.
Work at the intersection of science, manufacturing, quality systems, and clinical impact.
Join as an early employee (#13) with meaningful influence on company direction.
Grow into expanded scientific and operational leadership as the company scales.
