Director of Bioanalytical Strategy & External Partnerships

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

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Tuition reimbursement

Job summary

Bausch + Lomb seeks a senior bioanalytical leader to design and drive strategies for small molecules and biologics, spanning discovery through regulatory submissions. You will manage CROs, ensure data quality and regulatory defensibility, and shape plans for a potential internal non-GLP lab.

You will lead a team of scientists, align with Clinical, Regulatory, and Quality, and guide the bioanalytical program across modalities while ensuring compliance with ICH M10 and 21 CFR Part 11.

Qualifications

• Biopharmaceutical experience with small molecules and biologics.
• "Regulated bioanalysis" experience supporting IND/NDA/BLA submissions.

Responsibilities

• Define and own integrated bioanalytical strategies across modalities.
• Represent bioanalysis on cross-functional teams.
• Author IND/IMPD/NDA sections and respond to agency questions.
• Oversee external CROs and ensure data quality and regulatory defensibility.
• Lead internal non-GLP lab planning if approved.

Skills

Bioanalytical leadership

Cross-functional collaboration

Regulated bioanalysis (GLP)

CRO management

Team leadership

Strategy development

FDA/ICH guidance

Education

Ph.D. in analytical chemistry, biochemistry, pharmaceutical sciences, pharmacology, immunology or related (10+ yrs)

M.S. with 14+ yrs

B.S. with 16+ yrs

Tools

LC-MS/MS

Ligand-binding assays

qPCR/ddPCR

Job description

Bausch + Lomb seeks a senior bioanalytical leader to design and drive strategies for small molecules and biologics, spanning discovery through regulatory submissions. You will manage CROs, ensure data quality and regulatory defensibility, and shape plans for a potential internal non-GLP lab.

You will lead a team of scientists, align with Clinical, Regulatory, and Quality, and guide the bioanalytical program across modalities while ensuring compliance with ICH M10 and 21 CFR Part 11.