Director of Bioanalytical Sciences - Strategy & CRO Leadership

Bausch + Lomb; Augusta (ME); On-site; USD 175,000 - 240,000; Full time

Job summary

Bausch + Lomb is seeking a senior Bioanalytical program leader to guide strategy from discovery through lifecycle management, across small molecules and biologics. You will define platform approaches, author regulatory content, and oversee CROs to ensure data integrity and compliant results.

Lead a potential internal lab expansion while building a high-performing scientific team and aligning with Clinical, Regulatory, and Quality stakeholders globally.

Qualifications

• Ph.D. in analytical chemistry or related discipline with 10+ years industry experience.
• Demonstrated regulatory bioanalysis experience (GLP) supporting IND/NDA/BLA submissions.
• Experience managing bioanalytical CROs as sponsor-side lead.
• Leadership experience hiring and developing scientific staff.

Responsibilities

• Define and own integrated bioanalytical strategies across modalities (small/large molecules, biomarkers, ADA).
• Represent bioanalysis in cross-functional teams and regulatory interactions.
• Own CRO governance and vendor management, ensuring quality and timelines.
• Lead internal non-GLP lab build including business case and facility planning.
• Mentor and develop a high-performing bioanalytical team.

Skills

Bioanalysis leadership

LC-MS/MS

Ligand-binding assays

GLP regulatory experience

CRO management

ICH M10

FDA immunogenicity guidance

21 CFR Part 11

Education

Ph.D. in analytical chemistry

M.S. in related field

B.S. in related field

Tools

LC-MS/MS platforms

qPCR/ddPCR

Job description

Bausch + Lomb is seeking a senior Bioanalytical program leader to guide strategy from discovery through lifecycle management, across small molecules and biologics. You will define platform approaches, author regulatory content, and oversee CROs to ensure data integrity and compliant results.

Lead a potential internal lab expansion while building a high-performing scientific team and aligning with Clinical, Regulatory, and Quality stakeholders globally.