Director of Bioanalytical Chemistry

Director of Bioanalytical Chemistry

DEPARTMENT: Bioanalytical Chemistry

REPORTS TO: Department Management

LOCATION: Lexington, MA/moving to Waltham, MA Q1 2027 (on-site/hybrid)

POSITION SUMMARY

The Director of Bioanalytical Chemistry is a Senior Leadership role responsible for bioanalytical strategies, laboratory operations, and regulatory compliance for drug and combination product development. The duties include managing teams of scientists, designing and validating analytical methods, analyzing complex data from biological samples, and ensuring compliance with standards like GLP/GCP for preclinical and clinical studies. This role requires expertise in techniques such as LC-MS/MS, ELISA, and biomarker analysis, and involves significant cross-functional collaboration.

The individual is responsible for ensuring CBSET maintains its outstanding and cutting-edge services and delivers high-quality results and will play a leadership role in setting plans for strategic growth of the business. Key management oversight responsibilities in this role include laboratory operations and workflow, compliance with Good Laboratory Practices (GLPs), and hiring, management and training oversight of bioanalytical laboratory staff. Advanced degree and expertise in the field of bioanalytical and/or preclinical labs is desirable, and minimum of 5 years of successful management and business leadership. Excellence in communication skills, professionalism, and team building a must.

Salary range is $150,000 - $225,000/year. (Please note, salaries vary within the range based on factors including, but not limited to, experience, skills, education, and certifications.)

KEY RESPONSIBILITIES

• Lead and manage teams of bioanalytical scientists and support staff, guiding their work and contributing to strategic decisions.
• Oversee the design, development, and validation of robust bioanalytical assays, including pharmacokinetics (PK), anti-drug antibodies (ADA), and biomarker methods, using various platforms such as LC-MS/MS and immunoassays (ELISA, MSD, etc.).
• Plan and execute bioanalytical studies to support drug development, including pharmacokinetic (PK), pharmacodynamic (PD), and biomarker analysis.
• Review, interpret, and present complex data to internal and external stakeholders, ensuring scientific accuracy and actionable insights.
• Ensure all bioanalytical activities and data meet regulatory standards and guidelines, such as GLP/GCP.
• Work with cross-functional teams, including project managers, regulatory affairs, and external partners, to advance drug development programs.
• Build, lead, and mentor a high-performing team of scientists and technical staff, fostering a collaborative and innovative work environment.
• Directly oversee Bioanalytical Managers and Supervisors, with indirect oversight of technical and scientific staff.
• Develop staffing plans and laboratory department budgets to support strategic growth.
• Work interdepartmentally with other directors and staff to maintain and improve processes and consistency and meet internal timelines.
• Determine laboratory designs, key equipment purchases, and capital investments to enable growth targets.
• Provide bioanalytical input into research and development plans and contribute to the overall strategy for product pipelines.
• Maintain and expand client relationships.
• Manage the planning, execution, and interpretation of bioanalytical studies, troubleshooting analytical challenges and ensuring data integrity and quality control.
• Act as the primary scientific liaison, collaborating closely with cross-functional teams and external partners (CROs, external vendors) to ensure alignment with project goals.
• Ensure compliance with Good Laboratory Practice (GLP) standards, including in laboratory operations, safety, record-keeping and archiving, and with departmental policies, SOPs, and protocols.
• Perform all other related duties as assigned.

QUALIFICATIONS:

Required:

• Required >15 years in bioanalytical sciences within the biopharmaceutical industry, including significant experience (5+ years) in a scientific leadership or management role in a regulated environment. CRO experience is preferred with medical device specialty. Deep expertise in bioanalytical techniques, relevant instrumentation (e.g., LC-MS/MS, ELISA), and laboratory information management systems (LIMS). In-depth understanding of global regulatory landscape and guidance, USDA, FDA, EMA, ICH M10, and OUS regulations. Strong leadership, project management, problem-solving, and exceptional communication skills (verbal and written) are essential for driving scientific decisions and managing diverse teams and stakeholders.
• PhD in analytical chemistry, biochemistry, pharmaceutical sciences, pharmacology, immunology, or a related discipline preferred.
• Alternatively, an MS or BS with >15+ years of relevant hands-on and leadership experience.
• In-depth knowledge of global regulations and guidelines, including ICH M10, FDA immunogenicity guidance, GLP/GCP/GCLP standards, and 21 CFR Part 11.
• Extensive experience selecting, qualifying, and managing external Contract Research Organizations (CROs), overseeing method development, validation, and sample analysis.
• Establishing tiered assay strategies (discovery, GLP-validated, and GCP-compliant clinical bioanalysis) for pharmacokinetic (PK), pharmacodynamic (PD), and biomarker endpoints.
• Demonstrated experience hiring, mentoring, and directly managing a team of scientific staff, as well as influencing matrixed cross-functional program teams.
• Hiring, mentoring, and leading internal scientific teams while managing departmental operating and capital budgets.
• Direct experience authoring and reviewing bioanalytical reports for regulatory submissions globally.

Preferred:

• Prior experience establishing, expanding, or designing an internal laboratory facility from the ground up, including capital planning and instrument qualification.
• Comprehensive understanding of evolving global bioanalytical guidance documents (e.g., ICH M10 guidelines).
• Demonstrated ability to align bioanalytical strategies directly with overall corporate drug development portfolios and therapeutic area goals.

PHYSICAL DEMANDS:

• Light Lifting & Mobility: Occasional walking and standing to visit, tour, or audit internal or external partner (CRO) laboratories. Ability to lift or move lightweight office or lab supplies up to 15-20 pounds.
• PPE and Hazard Compliance: When entering laboratory environments, the ability to wear personal protective equipment (PPE) such as safety glasses, lab coats, and gloves.
• Acuteness to Environment: Ability to work in environments that may have exposure to chemicals, biological samples, or low-level noise from laboratory equipment.

WORK ENVIRONMENT:

• Primarily an office working environment with quiet noise conditions.
• Occasional presence in animal facility and laboratory areas with moderate noise possible, when escorting candidates or new hires on facility tours.

COMMENTS:

This position does not typically require travel; occasional local travel may be required for job fairs, campus recruiting events, or industry conferences.

WHAT CBSET OFFERS:

• The opportunity to help build a commercial laboratory from the ground up inside a growing, well-capitalized firm.
• Direct exposure to executive leadership and a clear line of sight to the company's growth strategy
• Comprehensive benefits package.

Please contact Shannon Tierney, Vice President of HR (stierney@cbset.com), for more information.

All employees are required to satisfactorily perform the essential duties and responsibilities of their position. • The essential duties and responsibilities listed above are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.

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