Analytical Sciences Lead, Biologics Development

Bora Pharmaceuticals; Rockville (MD); On-site; USD 127,000 - 175,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Retirement plan

Professional development

Job summary

Bora Pharmaceuticals seeks an Associate Director to lead Analytical Sciences in BioPharmaceutical Development for biologics characterization and method development. You will supervise staff, drive analytical strategy, and ensure high-quality data supporting development through commercialization.

You will collaborate with CMC teams to align timelines with regulatory standards, mentor staff, and implement robust analytical workflows across MS, HPLC/CE, and related platforms.

Qualifications

• PhD or equivalent with extensive biologics experience in analytical development and characterization.
• Experience in design and execution of analytical comparability studies for biologics.
• Strong track record in leading cross-functional teams and delivering regulatory-ready data.

Responsibilities

• Lead the analytical characterization group and develop methods (MS, chromatography, electrophoretic) for biologic programs.
• Provide hands-on support for testing with reference standards and comparability studies.
• Represent Analytical Sciences in CMC teams and align with project timelines and regulatory expectations.

Skills

Protein characterization

Structure-function analysis

Analytical method development

Leadership

Project management

DOE & QbD

Statistical tools

Regulatory documentation

HPLC/CE methods

CRO/vendor management

Education

PhD in Biochemistry/Chemistry/Chemical Engineering/Pharmaceutical Sciences

MS in Biochemistry/Chemistry/Chemical Engineering/Life Sciences

BS in Biochemistry/Chemistry/Engineering/Life Sciences

8+ years biologics experience

People management experience

Tools

UPLC

Mass spectrometry (MS)

HPLC/CE methods

Instrument troubleshooting

Job description

Bora Pharmaceuticals seeks an Associate Director to lead Analytical Sciences in BioPharmaceutical Development for biologics characterization and method development. You will supervise staff, drive analytical strategy, and ensure high-quality data supporting development through commercialization.

You will collaborate with CMC teams to align timelines with regulatory standards, mentor staff, and implement robust analytical workflows across MS, HPLC/CE, and related platforms.