Blonde Inc.
Drug Substance Senior Specialist – Biologics (Antibodies)
Blonde Inc., Boston, Massachusetts, us, 02298
Hemab is a clinical-stage biotech company on a mission to develop innovative treatments for neglected bleeding and thrombotic disorders. With sites in Copenhagen and Boston, we combine high-impact science with a collaborative culture as we progress toward commercialization.
Position Summary We are seeking a Drug Substance Senior Specialist with strong experience in biologics process development and validation. You will play a key role in driving process characterization, validation, and technology transfer for antibody programs in close collaboration with our CDMOs.
This position spans both early- and late-stage development, ensuring smooth progression from clinical manufacturing to commercial readiness.
Key Responsibilities Early-Stage Development Support early-stage antibody programs by applying phase-appropriate development strategies. Collaborate with Quality, Regulatory, and Analytical teams to align on validation approaches. Provide technical input to CDMOs on process design, scale-up, and risk assessments.
Process Characterization & Validation Plan and manage process performance qualification (PPQ) and characterization studies in partnership with CDMOs. Define and document CPPs, CQAs, and control strategies based on risk and data-driven insights. Ensure validation documentation (protocols, reports, summaries) complies with ICH Q8–Q11, FDA, and EMA expectations. Support implementation of continuous process verification (CPV) and lifecycle validation strategies.
Late-Stage Development & Technology Transfer Oversee technology transfer to external manufacturing partners for commercial readiness. Contribute to CMC regulatory submissions (BLA/MAA) focusing on validation and control strategy. Coordinate comparability studies and process optimization activities with CDMOs. Monitor regulatory trends and integrate new validation approaches. Identify and execute opportunities for process optimization and cost reduction. Share best practices and mentor colleagues in validation science.
Qualifications Education & Experience Master’s degree in biotechnology, chemical engineering, pharmaceutical sciences, or related field. 8+ years of industry experience in biologics process development and validation, including collaboration with CDMOs.
Technical Expertise Proven experience with PPQ and process characterization for antibody drug substances. Solid understanding of ICH Q8–Q11 and global validation expectations. Practical knowledge of commercial-scale GMP operations, tech transfer, and regulatory submissions. Experience in early-stage process development and scale-up. Strong project management and organizational abilities. Excellent communication and technical writing skills for regulatory documentation. Collaborative mindset and ability to work effectively with external partners. Flexible, proactive, and comfortable operating in a fast-paced biotech environment.
Working Conditions Travel: ~15 days per year (flexible) Reports to: Emil Poulsen, Director of Drug Substance Development, CMC Team: CMC and Manufacturing
Apply for the position
Drug Substance Senior Specialist – Biologics (Antibodies) #J-18808-Ljbffr
Position Summary We are seeking a Drug Substance Senior Specialist with strong experience in biologics process development and validation. You will play a key role in driving process characterization, validation, and technology transfer for antibody programs in close collaboration with our CDMOs.
This position spans both early- and late-stage development, ensuring smooth progression from clinical manufacturing to commercial readiness.
Key Responsibilities Early-Stage Development Support early-stage antibody programs by applying phase-appropriate development strategies. Collaborate with Quality, Regulatory, and Analytical teams to align on validation approaches. Provide technical input to CDMOs on process design, scale-up, and risk assessments.
Process Characterization & Validation Plan and manage process performance qualification (PPQ) and characterization studies in partnership with CDMOs. Define and document CPPs, CQAs, and control strategies based on risk and data-driven insights. Ensure validation documentation (protocols, reports, summaries) complies with ICH Q8–Q11, FDA, and EMA expectations. Support implementation of continuous process verification (CPV) and lifecycle validation strategies.
Late-Stage Development & Technology Transfer Oversee technology transfer to external manufacturing partners for commercial readiness. Contribute to CMC regulatory submissions (BLA/MAA) focusing on validation and control strategy. Coordinate comparability studies and process optimization activities with CDMOs. Monitor regulatory trends and integrate new validation approaches. Identify and execute opportunities for process optimization and cost reduction. Share best practices and mentor colleagues in validation science.
Qualifications Education & Experience Master’s degree in biotechnology, chemical engineering, pharmaceutical sciences, or related field. 8+ years of industry experience in biologics process development and validation, including collaboration with CDMOs.
Technical Expertise Proven experience with PPQ and process characterization for antibody drug substances. Solid understanding of ICH Q8–Q11 and global validation expectations. Practical knowledge of commercial-scale GMP operations, tech transfer, and regulatory submissions. Experience in early-stage process development and scale-up. Strong project management and organizational abilities. Excellent communication and technical writing skills for regulatory documentation. Collaborative mindset and ability to work effectively with external partners. Flexible, proactive, and comfortable operating in a fast-paced biotech environment.
Working Conditions Travel: ~15 days per year (flexible) Reports to: Emil Poulsen, Director of Drug Substance Development, CMC Team: CMC and Manufacturing
Apply for the position
Drug Substance Senior Specialist – Biologics (Antibodies) #J-18808-Ljbffr