Manager, Bioanalytical Services

Piper Companies is seeking a Manager, Bioanalytical Services to oversee laboratory operations supporting pharmacokinetics and immunogenicity programs. This Manager will lead ADA Operations and provide oversight to two supervisors with teams beneath them, ensuring high-quality data delivery, compliance with regulatory requirements, and effective coordination across scientific and operational functions. This is a 5 days a week onsite posiiton in Whitesboro, NY.

Responsibilities

• Oversee day-to-day ADA Operations, including sample analysis, workflow management, and coordination across bioanalytical teams.
• Lead and mentor two supervisors and their respective teams to ensure operational excellence, scientific accuracy, and adherence to timelines.
• Support and resolve complex analytical challenges, including assay troubleshooting, interpretation of results, and technical guidance.
• Provide oversight for deviations, investigations, and corrective actions to maintain regulatory compliance and data integrity.
• Represent the laboratory in sponsor meetings, providing consultation, study updates, and scientific insight.
• Ensure all laboratory activities meet GLP and other regulatory standards, with proactive focus on quality control and documentation.
• Collaborate with cross-functional groups including clinical, regulatory, quality, and project management teams to align on objectives and deliverables.
• Drive process improvements to streamline workflows, increase efficiency, and support operational scalability.
• Support method development, validation, and ongoing assay performance as needed for ADA and PK programs.

Qualifications

• Bachelor’s degree or advanced degree in Biochemistry, Pharmacology, or a related scientific field.
• Proven experience in bioanalytical operations, laboratory management, or a related scientific leadership role.
• Strong understanding of GLP requirements, quality systems, and regulatory expectations for bioanalytical laboratories.
• Demonstrated leadership capabilities, including management of supervisors and complex lab workflows.
• Strong problem solving, organizational, and prioritization skills, with experience operating in a fast-paced environment.
• Excellent communication and collaboration skills, with experience supporting cross functional project teams.

Additional Details

• This is a full time onsite role based in Whitesboro, NY.
• 120-140K annually
• Must be authorized to work in the United States.
• Full comprehensive benefits package including medical, dental, vision, 401(k), PTO, and sick leave as required by law.

Keywords:

Bioanalytical Services, ADA, Anti Drug Antibodies, Immunogenicity, PK, Pharmacokinetics, GLP, Laboratory Operations, Lab Management, Bioanalytical Lab Manager, Deviations, Investigations, Regulatory Compliance, Sponsor Meetings, Assay Troubleshooting, Method Validation, Workflow Optimization, Scientific Operations, Biochemistry, Pharmacology, Clinical Research, Team Leadership

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