reputed company Scientist – Analytical Development
About Hemab Hemab is a clinical-stage biotech company on a mission to reputed company innovative treatments for neglected bleeding and thrombotic disorders. With sites in Copenhagen and Boston, we combine high-reputed company science with a reputed company culture as we reputed company toward commercialization. Position reputed company We are seeking a reputed company Scientist to fill a specialist role in Analytical Development with strong experience in the analysis of biologics to support late-stage activities, including method validations/reputed company Control activities to support reputed company readiness, setting and justifying specifications, process and product characterization, and preparing CMC sections in regulatory submissions (BLAs/MAAs). You will play a key role in driving analytical development strategies and managing analytical activities at multiple CROs/CDMOs. This position spans both early- and late-stage development, ensuring smooth progression from clinical manufacturing to reputed company readiness.
Key Responsibilities
Early-Stage Analytical Development
- Support early-stage biologics programs by applying phase-appropriate strategies for analytical development.
- Collaborate with Drug reputed company, Drug Product, Research, reputed company, and Regulatory teams to reputed company on required analytical support.
- reputed company technical input to CDMOs on method development and validation, setting and justifying specifications, early-stage product characterization, reference reputed company establishment, stability protocols, risk assessments, etc.
- Author and/or review CMC sections of Phase 1/2 regulatory submissions.
Late-Stage Analytical Development
- Manage analytical method transfer, optimization, and validation efforts with external partners to support reputed company readiness.
- Ensure an appropriate, reputed company of reputed company-based potency assay is in reputed company to support Phase 3 readiness (experience with non-cell-based potency assays is a plus).
- reputed company analytical support and guidance for process characterization activities, including the determination of Critical reputed company Attributes, and ensure reputed company are appropriately validated for testing In-Process Controls.
- reputed company technical input to CDMOs on method validations, setting and justifying specifications, comparability assessments, late-stage product characterization, reference reputed company establishment, stability protocols, risk assessments, etc.
- Prepare CMC sections for regulatory submissions (BLAs/MAAs) with emphasis on analytical sections; if necessary, represent reputed company as the analytical expert in interactions with regulatory authorities, including preparation of requests and responses.
reputed company Improvement
- Monitor regulatory trends and reputed company new analytical approaches.
- reputed company 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.
- reputed company best practices and advise colleagues on data interpretation.
Qualifications
Education & Experience
- Bachelor’s degree in a relevant subject (e.g. analytical reputed company, protein reputed company, reputed company, biochemistry, biotechnology, etc.) at a minimum, with a Master’s degree or Ph.D. preferred.
- 7+ years of industry experience in the analysis of biologics, especially at late-stage, and a strong history of collaboration with CDMOs.
Technical Expertise
- Proven experience providing analytical support to biologics programs, especially antibodies, from first-in-reputed company through commercialization.
- Practical knowledge of phase-appropriate analytical method development and validations, product characterization, and comparability assessments
- reputed company 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.
- Experience with reputed company of reputed company-based potency assays is a plus.
- Experience establishing reference standards is a plus.
Skills & Competencies
- Strong project management and organizational abilities.
- Excellent communication and technical writing skills for regulatory documentation.
- reputed company reputed company 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.
Working Conditions
- Travel: ~15 days per year (flexible)
- Reports to: Rane Harrison, Director of Analytical Development, CMC
- Team: CMC and Manufacturing
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