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Assay Development Manager Jobs in Massachusetts (NOW HIRING)

Quanterix

Project Manager

Bedford, MA

$100K - $120K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Project Manager, Custom Assay DevelopmentBedford, MAQuanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in disease research, diagnostics, and drug development.

Posted today

Genezen

Sr. Scientist, Analytical Development

Lexington, MA · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Direct line management experience is required. JOB RESPONSIBILITIES * Experience with AAV assay development is critical * Expert in method qualification/validation experimental design per ICH ...

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Assay Development Manager information

What are some common challenges faced by an assay development manager during the early stages of a new project?

One of the main challenges Assay Development Managers encounter in the early phases of a project is balancing the need for high sensitivity and specificity with practicality and scalability. They often need to troubleshoot unexpected assay variability, optimize protocols, and ensure the reproducibility of results under tight deadlines. Additionally, coordinating input from cross-functional teams—such as R&D scientists, quality assurance, and regulatory affairs—can present logistical hurdles. Effective communication and project management skills are essential to navigate these complexities and drive the project forward.

What is an assay development manager?

An Assay Development Manager is a scientific professional responsible for leading the design, development, validation, and optimization of laboratory assays, which are tests used to measure the presence or amount of a substance in biological samples. They manage teams of scientists and collaborate closely with research, quality, and regulatory departments to ensure assays meet scientific and regulatory requirements. Their work is vital in fields such as biotechnology, pharmaceuticals, and diagnostics, supporting drug discovery, disease diagnosis, and product development.

What is the difference between Assay Development Manager vs Laboratory Supervisor?

AspectAssay Development ManagerLaboratory Supervisor
CredentialsBachelor's/Master's in Life Sciences, relevant certificationsBachelor's in Life Sciences or related field, relevant certifications
Work EnvironmentResearch labs, biotech or pharma companiesLaboratories, clinical or research settings
Employer & IndustryBiotech, pharmaceutical, diagnosticsResearch institutions, hospitals, biotech
Primary FocusDesigning and optimizing assays, project managementOverseeing daily lab operations, staff supervision

The Assay Development Manager focuses on designing, developing, and optimizing assays, often managing projects and teams. In contrast, the Laboratory Supervisor oversees daily lab operations and staff, ensuring smooth workflow. Both roles require relevant scientific credentials and work in similar environments, but their core responsibilities differ significantly.

What are the key skills and qualifications needed to thrive as an assay development manager?

To thrive as an Assay Development Manager, you need a strong background in molecular biology, biochemistry, or a related field, typically with an advanced degree and experience in assay design and validation. Familiarity with laboratory automation, data analysis software, and quality management systems is essential, along with relevant certifications like GLP or ISO standards. Strong project management, leadership, and communication skills help drive cross-functional teams and ensure effective collaboration. These competencies are crucial for delivering reliable assays that meet scientific, regulatory, and business objectives.

What are the most commonly searched types of Assay Development jobs in Massachusetts?

The most popular types of Assay Development jobs in Massachusetts are:

What are popular job titles related to Assay Development Manager jobs in Massachusetts?

For Assay Development Manager jobs in Massachusetts, the most frequently searched job titles are:

What job categories do people searching Assay Development Manager jobs in Massachusetts look for?

The top searched job categories for Assay Development Manager jobs in Massachusetts are:

Assay Development Manager jobs near you

Sr. Scientist, Bioanalytical Biomarker Sciences

City Therapeutics

Cambridge, MA • On-site

$38.50 - $48.25/hr

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 25 days ago

Job description

TEAM: Bioanalytical and Biomarker Sciences
Position Summary:
We are seeking a highly motivated and skilled Senior Scientist with expertise in bioanalytical and biomarker assays to join our growing Translational Sciences team. This role will report to the Head of Bioanalytical and Biomarker Sciences (BBS) and will represent the BBS function across discovery and early development programs.
The successful candidate will bring strong experience in bioanalytical/biomarker assay development, qualification, validation, and will provide critical analytical support to enable data-driven decision-making from drug candidate selection through clinical development. This individual will work closely with internal research teams, cross-functional program partners, and external CROs to support both discovery- and development-stage programs.
The ideal candidate will have hands-on experience with a variety of assays including ligand binding assays, ideally, in a regulated environment. He/She will play a key role in advancing analytical method development, overseeing PK/PD sample analysis, interpreting complex data, and directing CRO activities as needed to ensure high-quality, decision-enabling bioanalytical and biomarker data.
Key Responsibilities
  • Design and execute bioanalytical and biomarker assay development, qualification, and validation activities, including, ligand-binding (ELISA, hybridization ELISA etc.), and immunogenicity assays, both internally and through CRO partners, to support drug candidate selection and regulatory submissions.
  • Generate and oversee bioanalytical data in partnership with PK scientists to support nonclinical programs and inform dose selection for Phase 1-3 clinical siRNA candidates.
  • Serve as the bioanalytical and biomarker lead on multidisciplinary project teams, collaborating with chemistry, platform biology, computational biology, clinical, regulatory, CMC, and other cross-functional partners to advance discovery and early development programs.
  • Manage CRO activities related to bioanalytical and biomarker assay development, qualification, validation, and sample analysis in support of discovery, nonclinical, and CTA/IND-enabling studies.
  • Prepare high-quality bioanalytical summaries, technical reports, and regulatory document contributions, including sections for INDs/CTAs, Investigator's Brochures, briefing books, and other submission materials.
  • Ensure compliance with applicable regulatory guidelines, SOPs, study protocols, and data integrity principles across all bioanalytical and biomarker-related activities.
  • Lead the preparation, review, and implementation of CRO Statements of Work (SOWs) for bioanalytical and biomarker activities, ensuring clear study scope, deliverables, timelines, assay requirements, sample analysis plans, reporting expectations, and executional alignment with program objectives.
  • Monitor emerging trends and best practices in bioanalytical science, biomarker assay technologies, and analytical platforms, and contribute to the implementation of innovative tools and approaches.

Qualifications
  • Ph D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 3-5+ years of relevant industry experience, or M.S. with 6+ years of relevant industry experience.
  • Strong expertise in regulated bioanalytical assay development, including assay qualification, validation, and regulatory requirements to support nonclinical and clinical studies.
  • Proficiency across multiple bioanalytical assay platforms, including ligand-binding assays, and immunogenicity assays in support of PK, PD, biomarker, and anti-drug antibody assessments.
  • Experience managing CRO relationships and externalized bioanalytical activities, including SOW preparation, review, implementation, study execution, data review, and timely delivery of high-quality reports.
  • Familiarity with regulatory expectations and guidance relevant to early-stage drug development.
  • Demonstrated adaptability, ownership, and collaborative mindset, with the ability to manage diverse responsibilities and shifting priorities in a dynamic, fast-paced environment.
  • Excellent problem-solving, analytical, and communication skills, with the ability to interpret complex quantitative data and clearly convey key findings to diverse scientific, clinical, regulatory, and cross-functional audiences.

Preferred Qualifications
  • Proven experience developing and supporting bioanalytical and biomarker assays for oligonucleotide therapeutics, with experience in siRNA or other RNA-based modalities preferred.
  • Experience working with CROs and managing outsourced bioanalytical and biomarker assay activities, including assay development, qualification, validation, sample analysis, data review, troubleshooting, and report finalization.
  • Experience supporting IND/CTA-enabling studies and/or early clinical development programs, including generation and interpretation of bioanalytical data for regulatory submissions.
  • Knowledge of regulatory bioanalytical guidance and expectations, including FDA, EMA, and ICH guidelines, is a plus.

Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including relevant skills, experience, internal equity, relevant education or training and market dynamics. In addition, this role is eligible for an annual cash bonus and equity compensation. City Therapeutics offers a comprehensive and competitive benefits package including medical, dental, vision, life insurance, health and dependent care FSA accounts, HSA/HRA accounts with company contributions, in addition to a 401(k) with competitive company match.
Per Year Salary Range: $136,000 to $154,000.
City Therapeutics is accepting resumes/CVs from direct applicants only. Recruitment agency submissions will not be accepted at this time.
City Therapeutics is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership, or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing); or any other characteristic protected by law.
Please note this role is required to be on-site at our offices in Cambridge, MA 5 days a week.

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