Biologics Analytical Sciences Lead

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

Benefits offered by this job

Competitive salary and incentives

Comprehensive health coverage

Retirement with employer matching

Paid time off

Professional development opportunities

Wellness programs and resources

Employee Assistance Program and Mental

Job summary

Bora Biologics USA LLC is seeking an Associate Director to lead Analytical Sciences in BioPharmaceutical Development. The role focuses on developing analytical characterization methods for biologics, guiding method selection, execution, and interpretation, and mentoring a team through early to late-stage development.

The candidate will oversee instrumentation, collaborate with CMC teams, and ensure regulatory compliance while advancing pipeline molecules toward commercialization.

Qualifications

• PhD or MSc/BS with extensive biologics experience and leadership
• Experience in product characterization for late-phase and commercialization
• Strong verbal and technical writing skills; regulatory document experience

Responsibilities

• Lead analytical characterization program for biologics
• Supervise scientists; mentor staff and drive timely analytic deliverables
• Develop control strategies in line with ICH/GxP guidelines
• Design and execute comparability studies and qualification of methods
• Collaborate with CMC teams across development stages
• Maintain instrumentation and oversee method development activities

Skills

Protein characterization methods

Analytical leadership

DOE / QbD principles

Statistical tools

Collaborative cross-CMC work

Regulatory documentation

Education

PhD in Biochemistry or related field

MS in Biochemistry or related field

BS in Biochemistry or related field

Tools

UPLC

Mass spectrometry

HPLC / CE methods

Job description

Bora Biologics USA LLC is seeking an Associate Director to lead Analytical Sciences in BioPharmaceutical Development. The role focuses on developing analytical characterization methods for biologics, guiding method selection, execution, and interpretation, and mentoring a team through early to late-stage development.

The candidate will oversee instrumentation, collaborate with CMC teams, and ensure regulatory compliance while advancing pipeline molecules toward commercialization.