Hemab Therapeutics · 6 hours ago
Principal Scientist – Analytical Development
Cambridge, MA
Full-time
Onsite
Senior Level, Lead/Staff
7+ years expHemab Therapeutics is a clinical-stage biotech company focused on developing innovative treatments for neglected bleeding and thrombotic disorders. They are seeking a Principal Scientist in Analytical Development to drive strategies and manage analytical activities, ensuring smooth progression from clinical manufacturing to commercial readiness.
BiotechnologyLife ScienceMedicalPharmaceutical
Responsibilities
Support early-stage biologics programs by applying phase-appropriate strategies for analytical development
Collaborate with Drug Substance, Drug Product, Research, Quality, and Regulatory teams to align on required analytical support
Provide technical input to CDMOs on method development and validation, setting and justifying specifications, early-stage product characterization, reference standard establishment, stability protocols, risk assessments, etc
Author and/or review CMC sections of Phase 1/2 regulatory submissions
Manage analytical method transfer, optimization, and validation efforts with external partners to support commercial readiness
Ensure an appropriate, mechanism of action-based potency assay is in place to support Phase 3 readiness (experience with non-cell-based potency assays is a plus)
Provide analytical support and guidance for process characterization activities, including the determination of Critical Quality Attributes, and ensure methods are appropriately validated for testing In-Process Controls
Provide technical input to CDMOs on method validations, setting and justifying specifications, comparability assessments, late-stage product characterization, reference standard establishment, stability protocols, risk assessments, etc
Prepare CMC sections for regulatory submissions (BLAs/MAAs) with emphasis on analytical sections; if necessary, represent the company as the analytical expert in interactions with regulatory authorities, including preparation of requests and responses
Monitor regulatory trends and integrate new analytical approaches
Lead and manage the work of analytical CROs/CDMOs, material suppliers, consultants, vendors, and collaborators to support analytical activities
Identify and execute opportunities to improve efficiency and reduce costs
Share best practices and advise colleagues on data interpretation
Qualification
Required
Bachelor's degree in a relevant subject (e.g. analytical chemistry, protein chemistry, chemistry, biochemistry, biotechnology, etc.) at a minimum
7+ years of industry experience in the analysis of biologics, especially at late-stage, and a strong history of collaboration with CDMOs
Proven experience providing analytical support to biologics programs, especially antibodies, from first-in-human through commercialization
Practical knowledge of phase-appropriate analytical method development and validations, product characterization, and comparability assessments
Direct experience with regulatory submissions such as BLAs/MAAs, ideally across multiple programs, especially to support late-stage biologics programs
Solid understanding of ICH guidelines and pharmacopeias for stability and method validation expectations
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 at a company spread out across multiple time zones
Preferred
Master's degree or Ph.D
Experience with mechanism of action-based potency assays
Experience establishing reference standards
Company
Hemab Therapeutics
Hemab is a clinical-stage biotech company developing the first prophylactic therapeutics for serious, underserved bleeding and thrombotic disorders.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$347MKey Investors
Sofinnova PartnersAccess BiotechnologyNovo Holdings
2025-10-27Series C· $157M
2023-02-21Series B· $135M
2021-07-22Series A· $55M
Leadership Team
Benny Sørensen
Chief Executive Officer
Mads Behrndt
Chief Financial Officer
Recent News
2025-11-19
Company data provided by crunchbase