CMC Drug Product Director — Lead Biologics CDMOs

BridgeBio Pharma; Owens (OH); Hybrid; USD 260,000 - 278,000; Full time

Benefits offered by this job

Market-leading compensation

401(k) with employer match

Employee Stock Purchase Program (ESPP)

Hybrid work model

Comprehensive health benefits

Job summary

BridgeBio Pharma seeks a senior technical leader to oversee CDMOs for drug product CTM production, process validation, and regulatory submissions. You will guide cross-functional teams and ensure high-quality manufacturing processes align with regulatory expectations.

Ideal candidates bring a PhD with 12+ years in biotech, strong expertise in biologics analytics, and a proven ability to manage CDMOs across development to IND/FIH, while partnering with program leadership in a fast-moving

Qualifications

• PhD with 12+ years of relevant industry experience, 8+ years on antibodies.
• Ability to communicate with CRO/CDMO/CMO on scope, results and updates.
• Experience managing CDMO from cell line development to IND/FIH.
• Knowledge of analytical methods for biologics: HPLC, CE-SDS, icIEF, LC-MS, SEC, DSC, glycosylation and PTMs.
• Strong understanding of cGMP, USP, ICH guidelines and industry best practices.
• Knowledge of CMC regulatory requirements for IND and NDA/MAA filings.
• Proven leadership and ability to drive cross-functional projects under time pressure.
• Excellent written and oral communication; comfortable presenting to regulatory agencies and CDMOs.
• Self-starter who thrives in a fast-moving environment and collaborates with program leadership.

Responsibilities

• Oversee CDMOs and CTM production activities, troubleshooting, risk assessments, and validation
• Provide technical direction to CDMOs and external labs to meet deadlines and standards
• Lead technical issue resolution with CDMOs on formulation, transfer, DOE, and results interpretation
• Develop and optimize scalable, cost-effective CTM production processes
• Lead process validation activities and CDMO reviews of reports
• Prepare manufacturing batch records, technical reports, data summaries, and CMC documents for regulatory submissions
• Coordinate with QA and Supply Chain to ensure timely manufacture and release of drug product
• Manage SOPs, change controls, deviations, and CAPAs with GMP knowledge
• Ensure adherence to FDA/EMA/ICH/GCP/GMP guidelines
• Author/review CMC sections of regulatory filings (INDs, IMPD/IND amendments, NDA/MAA)

Skills

Leadership

CDMO management

Communication

Regulatory liaison

Analytical methods

Education

PhD in chemistry, pharmaceutical sciences, or related field

Tools

HPLC

LC-MS

icIEF

SEC

Job description

BridgeBio Pharma seeks a senior technical leader to oversee CDMOs for drug product CTM production, process validation, and regulatory submissions. You will guide cross-functional teams and ensure high-quality manufacturing processes align with regulatory expectations.

Ideal candidates bring a PhD with 12+ years in biotech, strong expertise in biologics analytics, and a proven ability to manage CDMOs across development to IND/FIH, while partnering with program leadership in a fast-moving