Technical Operations Manager Position Available In Middlesex, Massachusetts

Technical Operations Manager 3.3 3.3 out of 5 stars Acton, MA 01718 Position Summary Our client is seeking a Technical Operations Manager with deep expertise in immunochemistry, antibody-based assay development, and technology transfer to lead technical operations for our Symphony platform , a near-patient testing system designed to provide real-time biomarker analysis for sepsis and other acute conditions. This role will be critical in driving clinical readiness, supporting ongoing trials, and enabling a successful regulatory submission pathway (510(k)/PMA). The ideal candidate will have extensive experience overseeing assay redevelopment, reagent stability, and transfer to CRO/CMO partners, with a strong understanding of FDA and

ISO 13485

requirements. Key Responsibilities

• Lead and coordinate technical operations for the Symphony cartridge redevelopment and assay optimization , including IL-6 and other inflammatory biomarkers.
• Manage technology transfer activities to contract manufacturing organizations (CMOs), ensuring reproducibility, scalability, and compliance for cartridge production.
• Oversee antibody characterization, sourcing, and validation , ensuring reagent supply chain robustness for development, clinical, and commercial use.
• Work cross-functionally with clinical affairs, quality and regulatory teams to generate technical data for ongoing (e.g., SYMON-II) and FDA submissions.
• Support design control and design verification, validation (V&V) activities for Symphony assays and consumables, ensuring alignment with FDA regulations
• Develop and maintain risk management files , validation protocols (e.g., analytical, stability, lot-to-lot), and change control documentation.
• Serve as technical liaison with external CROs, CMOs, and suppliers , managing deliverables, timelines, and quality expectations.
• Negotiate rates and contracts with transportation and logistics providers
• Proactively identify and resolve potential supply issues that can affect product strategy.
• Ensure all activities conform to QMS requirements (ISO 13485, 21 CFR Part 820) and internal SOPs. Required Qualifications
• Bachelor’s degree in Biochemistry, Immunology, Biomedical Engineering, or related field; Master’s or PhD strongly preferred .
• Minimum 7+ years of experience in IVD, medical device, or diagnostics industry with a focus on immunoassay development and manufacturing .
• Proven success in technology transfer from R D to manufacturing (either internal or outsourced).
• Experience with antibody-based assay development , reagent selection, and performance characterization.
• Strong understanding of FDA regulatory requirements , including experience supporting 510(k), PMA, or EUA submissions.
• Hands-on knowledge of design control , risk management (ISO 14971), and

QSR/ISO 13485.

• and generating analytical and clinical validation datasets.
• Experience working with external vendors, CROs, and CMOs .
• Outstanding project management skills with the ability to prioritize, manage multiple vendors, and deliver on complex timelines.
• Strong communication and documentation skills; ability to translate technical challenges into cross-functional action. Preferred Qualifications
• Experience with point-of-care or near-patient diagnostics and microfluidic cartridge platforms.
• Prior exposure to clinical studies involving biomarkers (e.g., IL-6, CRP) and real- time data integration.
• Familiarity with automated manufacturing processes for IVD consumables.
• Prior involvement in scale-up of cartridge-based or microfluidic devices.
• Knowledge of reagent supply chain and global CMO/CRO management.
• Working knowledge of regulatory landscape.

Compensation & Benefits Base Salary Range:

$135,000 – $150,000 per year (commensurate with experience)

Equity Participation:

Eligible for stock option grant subject to Board approval

Bonus:

Annual performance-based bonus potential

Benefits:

Comprehensive health, dental, vision, 401(k) with company match, and PTO package

Other Benefits:

Parental leave, Flexible spending account, Disability Travel Expectations Occasional travel (up to 15%) required for an oversight of CMOs/CROs, supplier visits, and regulatory meetings as necessary. Domestic travel primarily; international travel may be required based on vendor relationships.

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Job Type:

Full-time Pay:

$135,000.00 – $150,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance

Compensation Package:

Bonus opportunities Stock options

Schedule:

8 hour shift Monday to

Friday Work Location:

In person