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Bioanalytical Project Manager Jobs in Massachusetts

BioAgilytix

Technical Writer (6-month contract)

Boston, MA · Remote

$35.58 - $40.87/hr

Responsible for second-level technical review of documents prior to review by the project manager (e.g., Bioanalytical Project Manager (BPM), Principal Investigator). * Responsible for maintaining ...

Orum Therapeutics

Bioanalytical Scientist

Lexington, MA · On-site

$150 - $180/day

Beyond assay management, you will serve as a strategic partner in project teams, leveraging ... Design and execute integrated Bioanalytical and PK/PD strategies for ADC programs, utilizing the ...

Orum Therapeutics

Bioanalytical Scientist

Lexington, MA · On-site

$39.50 - $49.75/hr

Beyond assay management, you will serve as a strategic partner in project teams, leveraging ... Design and execute integrated Bioanalytical and PK/PD strategies for ADC programs, utilizing the ...

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Bioanalytical Project Manager information

What does a Bioanalytical Project Manager do?

A Bioanalytical Project Manager oversees and coordinates bioanalytical studies, ensuring that projects are completed on time, within budget, and according to regulatory standards. They act as the main point of contact between clients, laboratory teams, and regulatory agencies, managing study timelines, resources, and data quality. Their responsibilities include planning project activities, monitoring progress, troubleshooting issues, and reporting results to stakeholders. They play a critical role in drug development by ensuring that bioanalytical testing meets scientific and compliance requirements.

What are the key skills and qualifications needed to thrive as a Bioanalytical Project Manager, and why are they important?

To thrive as a Bioanalytical Project Manager, you need a strong background in bioanalysis, project management experience, and typically a degree in life sciences or a related field. Familiarity with laboratory information management systems (LIMS), regulatory guidelines (such as GLP/GCP), and project management tools like MS Project is essential. Excellent communication, leadership, and organizational skills help manage cross-functional teams and client expectations. These skills ensure the successful planning, execution, and delivery of complex bioanalytical projects within regulatory and timeline constraints.

What are some common challenges faced by Bioanalytical Project Managers, and how can they be addressed?

Bioanalytical Project Managers often face challenges coordinating timelines across multiple stakeholders, such as laboratory teams, clients, and regulatory bodies. Managing shifting project priorities and ensuring data integrity under tight deadlines can also be demanding. To address these challenges, effective communication, proactive risk management, and strong organizational skills are essential. Regular status meetings, clear documentation, and building strong relationships with both internal and external partners help keep projects on track and ensure compliance with regulatory standards.

What is the difference between Bioanalytical Project Manager vs Bioanalytical Scientist?

AspectBioanalytical Project ManagerBioanalytical Scientist
CredentialsBachelor's or Master's in Life Sciences, PMP often preferredDegree in Biology, Chemistry, or related field; PhD or Master's common
Work EnvironmentProject teams, client meetings, coordination rolesLaboratory research, data analysis, method development
Employer & Industry UsagePharmaceutical, biotech companies, CROsResearch labs, pharmaceutical companies, CROs

The Bioanalytical Project Manager oversees project timelines, budgets, and client communication, ensuring successful completion. In contrast, the Bioanalytical Scientist focuses on experimental design, data collection, and method development. Both roles are essential in the bioanalytical industry but differ in responsibilities and daily tasks.

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What job categories do people searching Bioanalytical Project Manager jobs in Massachusetts look for? The top searched job categories for Bioanalytical Project Manager jobs in Massachusetts are:
What cities in Massachusetts are hiring for Bioanalytical Project Manager jobs? Cities in Massachusetts with the most Bioanalytical Project Manager job openings:
Bioanalytical Project Manager jobs near you
Infographic showing various Bioanalytical Project Manager job openings in Massachusetts as of July 2026, with employment types broken down into 5% Internship, 51% As Needed, 18% Full Time, 4% Part Time, 21% Nights, and 1% Summer. Highlights an 91% Physical, 4% Hybrid, and 5% Remote job distribution.

Scientist, Bioanalytical Development

Vistera Inc

Waltham, MA • On-site

$121K - $172K/yr

Full-time

Re-posted 26 days ago

Job description

Summary
The Scientist, Bioanalytical Development is responsible for performing laboratory activities and experiments related to the development and scientific qualification of bioanalytical methods for preclinical/clinical programs to assess PK. ADA and PD in preclinical and clinical samples. The Scientist, Bioanalytical Development will be responsible for activities related to the bioanalytical method development and qualification for non-regulated/exploratory methods and sample analysis from preclinical studies in support of drug development candidates. Reporting to the Associate Director in Bioanalytical Development, this role will be responsible for the execution of experiments to support IND filings / preclinical development as well as clinical method development. They may also oversee the activities of a research associates and perform project management activities for out-sourced methods including vendor management.
Visterra is seeking a flexible candidate with a working knowledge of large molecule/biologics analytical techniques and laboratory skills. The primary focus will be developing and performing bioanalytical methods for programs in preclinical and clinical development, documenting the methods used and summarizing the data collected. This individual will be responsible for the execution and documentation of experiments to develop bioassays and the empirical evaluation of custom reagents to support preclinical/clinical method development.
This is a full-time laboratory position based in Visterra's facility in Waltham, MA.
Responsibilities
  • Develop ligand binding methods including pharmacokinetic (PK), immunogenicity (ADA) and pharmacodynamic (PD) assays.
  • Design and independently execute experiments to select/identify appropriate bioanalytical reagents.
  • Oversee and perform sample analysis from preclinical and clinical studies.
  • Design and implement specialized in vitro studies designed to enhance mechanistic understanding of drug development candidates as needed on development programs.
  • Analyze data and trouble shoot assay development activities.
  • Write reports summarizing data and methods.
  • Manage and oversee activities of Research Associates.
  • Implement innovative technologies which offer pragmatic enhancements to the bioanalytical department.
  • Manage ongoing bioanalysis at external vendors to support large molecule drug candidates.
  • Negotiate CRO contracts and SOWs; from approval to execution.
  • Review, edit, and finalize method validation protocols, amendments, and reports, ensuring that documents meet project timelines, expectations, and deliverables, as well as Visterra's global regulatory and compliance requirements.
  • Other duties and responsibilities as required by departmental and business needs.
  • Travel as needed to attend conferences, events and vendor site visits.

Requirements
  • A minimum of 5 years of working experience, including hands-on laboratory experience in the bioanalysis or biotechnology industry.
  • An M.S. or Ph.D. in Immunology, Biology, Biochemistry, or related field is preferable, although candidates with a Bachelor of Science (BS) degree with significant research experience are also encouraged to apply
  • Experience with ligand binding method development using ELISA and MSD.
  • Working experiences with biologics.
  • Proven experience in the development and validation of regulated bioanalytical method assays for pharmacokinetic, pharmacodynamic and immunogenicity evaluation.
  • Experience with summarizing data in slides and reports.
  • Experience with vendor management and project management.
  • Knowledge of regulatory requirements, including GLP, GCP, ICH and other applicable guidelines for Bioanalytical development in support of clinical trials.
  • Extensive experience with a broad range of bioanalytical platforms including ELISA, MSD and Flow Cytometry and techniques including bridging, direct, indirect, and competitive assays.
  • Ability to manage a research associate as a direct-report, including assigning and reviewing tasks and mentoring and coaching.
  • Strong time management and organizational skills, attention to accuracy and detail, and the ability and willingness to multi-task as needed.
  • This individual will be highly analytical, goal-oriented, and timeline sensitive while maintaining high quality standards.

Company
Visterra is a clinical stage biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with kidney, immune-mediated and other hard-to-treat diseases. Our proprietary technology platform enables the design and engineering of precision antibody-based product candidates that specifically bind to, and modulate, key disease targets. Applying this technology to disease targets that are not adequately addressed by traditional therapeutic approaches, we are developing a robust pipeline of novel therapies for patients with unmet needs. Visterra's pipeline has multiple clinical-stage assets and one approved therapeutic, sibeprenlimab.
As a member of the Otsuka family of companies, we are uniquely positioned as a small, dynamic, nimble and innovative organization where individuals and teams are empowered to make big impacts - while benefiting from the support, strength, stability and long-term perspective of a 100-year-old global company. Visterra has approximately 105 employees and is located in Waltham, Massachusetts.
Visterra provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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