Director of Business Development

ClinLab Solutions Group; San Antonio (TX); On-site; USD 180,000 - 240,000; Full time

Job summary

ClinLab Solutions Group in Texas seeks a Director of Business Development to oversee GMP service laboratory operations, quality systems, and regulatory compliance.

You will lead client engagements, present results, coordinate validation programs, manage LIMS, and drive regulatory interactions with confidence.

Qualifications

• PhD or equivalent combination of education and experience required.
• Eight years of post-degree experience, or twelve years with a Master’s; four years leading scientific teams.
• Valid United States Driver’s License.
• Experience with microfluidic human cell assays and GMP/regulatory workflows.
• Hands-on expertise in GMP labs and regulatory submissions.
• Experience with assay qualification, validation, and data for regulatory filings.

Responsibilities

• Lead GMP compliance program, SOPs, training, deviation management, CAPA, and audits.
• Oversee laboratory operations from sample receipt to data review and release.
• Serve as primary technical contact for clients; lead study meetings and negotiate technical scopes.
• Prepare validation master plans, study reports, and regulatory-ready data packages.
• Manage LIMS selection, configuration, validation, and secure client access.
• Direct assay qualification and validation programs per ICH/FDA guidance.
• Contribute to regulatory filings by drafting technical sections and supporting agency interactions.
• Forecast resources, protect client IP, and ensure confidentiality.

Skills

Leadership

Regulatory knowledge

Project management

Client facing

Quality systems

Technical writing

Education

PhD in bioengineering, biomedical engineering, cell biology, immunology, or related field

Tools

LIMS

Data systems

Job description

The Director of Business Development is responsible for overseeing the daily operations and regulatory compliance of a GMP service laboratory, ensuring timely and validated results for clients. This role requires expertise in microfluidics, human cell culture, and laboratory quality systems, as well as strong leadership and client-facing skills.

Responsibilities:

• Lead and maintain laboratory compliance with GMP standards, including SOPs, training, equipment qualification, deviation management, CAPA, and change control, while hosting audits and inspections.
• Oversee all laboratory operations from sample receipt to data review and result release, ensuring turnaround times are met and quality standards are upheld.
• Act as the primary technical contact for clients, leading study meetings, presenting results, addressing questions, and negotiating technical scopes.
• Prepare and approve validation master plans, study reports, and regulatory-ready data packages, ensuring accuracy and compliance before client release.
• Manage LIMS selection, configuration, validation, and administration, ensuring secure and compliant data workflows and client access under regulatory controls.
• Direct assay qualification and validation programs for a range of readouts, adhering to ICH and FDA guidance for cell and gene therapy products.
• Contribute to regulatory filings by authoring and reviewing technical sections, and support client interactions with regulatory agencies regarding laboratory data.
• Forecast and schedule laboratory resources, protect client intellectual property, and ensure confidentiality through agreements and secure data handling.

Qualifications:

• PhD in bioengineering, biomedical engineering, cell biology, immunology, or a related field (or equivalent combination of education and experience).
• Eight years of post-degree experience, or twelve years with a Master’s degree; four years of experience managing scientific teams.
• Valid United States Driver’s License.
• Demonstrated experience with microfluidic human cell assays, validation plans, LIMS/data system implementation, GMP audits, and regulatory filings.
• Proven hands-on expertise in microfluidics or organ-on-chip systems and human primary cell culture.
• Track record of leading or working in GMP laboratories, including hosting audits or inspections.
• Experience with assay qualification, validation, and technical writing for regulatory submissions.
• Preferred: Experience leading fee-for-service labs, CROs, or core labs; knowledge of CAR T/NK-cells, TCR-T, gene therapy potency assays, live-cell imaging, flow cytometry, and multiplex cytokine platforms.
• Preferred: Experience interacting with FDA on New Approach Methodologies or MPS data, and working knowledge of 21 CFR Parts 210, 211, 11, and GLP (21 CFR Part 58).
• Strong communication and technical writing skills, with the ability to present complex data to clients and regulatory bodies.