Analytical Method Lead, Lifecycle Management (Biologics)

Biopharma Careers; Gaithersburg (MD); On-site; USD 146,000 - 234,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life and AD&D Insurance

HSA/FSA

Job summary

Biopharma Careers in Gaithersburg, MD seeks an Associate Director AS&T Lifecycle Management to lead analytical method lifecycle activities for monoclonal antibody programs, ensure GMP compliance, and support regulatory submissions (BLA/MAA).

The role requires deep technical acumen across chromatographic, spectroscopic and molecular biology techniques and cross-functional collaboration with CMC teams worldwide.

Qualifications

• Advanced degree in Biology, Chemistry, Pharmacy or related field; 10+ years in a regulated pharma environment.
• Expertise in chromatographic, spectroscopic, electrophoretic, immunoassay and molecular biology techniques for analysis of mAbs/ADCs.
• Hands-on assay development and method validation; data analysis and statistics.
• Strong background in CMC activities for late-stage development and commercial biologics.
• In-depth knowledge of ICH guidelines, GMP and industry best practices.
• Experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA) and health authorities interactions.
• Experience working in intercultural, cross-functional, and global teams.
• Structured working style with ability to define timelines and dependencies.
• Highly motivated to work in a fast-paced, evolving environment.

Responsibilities

• Provide technical analytical expertise for activities of the Gaithersburg antibody laboratory and global projects.
• Design and perform method validations and transfers; contribute to method lifecycle activities; hands-on lab work may be required.
• Participate in cross-functional technical discussions with CMC teams and external partners.
• Evaluate and review regulatory submission documents for approvals and market launch.
• Act as Analytical SME for regulatory filings and respond to health authorities.

Skills

GMP Compliance

Analytical Methods

Method Validations

Regulatory Filings

ICH Guidelines

Cross-functional Teams

Education

Advanced degree in Biology/Chemistry/Pharmacy

Tools

Chromatography

Spectroscopy

Electrophoresis

Immunoassays

Molecular Biology

Job description

Biopharma Careers in Gaithersburg, MD seeks an Associate Director AS&T Lifecycle Management to lead analytical method lifecycle activities for monoclonal antibody programs, ensure GMP compliance, and support regulatory submissions (BLA/MAA).

The role requires deep technical acumen across chromatographic, spectroscopic and molecular biology techniques and cross-functional collaboration with CMC teams worldwide.