Analytical Development, CMC


We are seeking an experienced, creative Director of Bioanalytical Development within CMC to help build and deliver the company’s pipeline and transform patient lives through the creation of a world class development team. The Director of Bioanalytical Development will be part of the company's CMC and Manufacturing team and contribute to the company's vision for developing next generation prophylactic products for people with high unmet need bleeding and thrombosis disorders. S(he) will report to the SVP, CMC and Manufacturing and will partner especially with leaders in Research, CMC, Regulatory and Program management. 

The Director of Bioanalytical Development will be a key CMC position that will provide biologics analysis expertise, oversee and be accountable for all bioanalytical activities, from cell line, drug substance and drug product developments to GMP manufacturing, including characterization, in process controls, monitoring, release and stability, for Hemab’s various assets. The candidate will provide strong technical leadership and oversight to the development of robust analytical development plans and methods and plays a critical role in our interactions with Contract Manufacturing Organizations/Contract Research Organizations. Furthermore, this role leads broadly in a cross-functional and multicultural environment and leverages an extensive experience to represent CMC Bioanalytics in discussions with external and internal stakeholders.

The candidate must be an entrepreneurial, highly motivated and purpose driven leader who is able to flexibly and efficiently lead and interact with multi-disciplinary teams within our focus area of bleeding and thrombosis. The successful candidate will have a track record of accomplishments in biologics analytical development, especially for antibodies modalities and notably collaborating with external labs. S(he) must exhibit excellent leadership, project management, and strong collaboration and communication skills. They should be ready to champion new ideas in a very dynamic, international, and innovative environment.

Key Responsibilities:

  • Working with cross-functional R&D partners, drive, develop and execute the Bioanalytical part of the CMC and Manufacturing strategy (for Drug Substance and Drug Product) of an early stage, big concept biotech with direct responsibility over multiple CMC projects, including longer term options for moving away from a CMO based manufacturing approach. 
  • Lead analytical development and product characterization activities including driving the development and implementation of overall analytical control strategy and performing risk assessment following QbD principle. Lead critical quality attributes (CQAs) assessments to support phase-appropriate control system strategy.
  • Deliver robust and cost-effective analytical methods for product quality assessment (especially chromatography-, capillary-, spectroscopy-, and mass spectrometry-based analytical methods), stability protocols, shelf-life setting, product comparability and specifications to support the target product/clinical profile. Ensure analytical support for cell-line, bioprocess and formulation development activities and cGMP clinical and commercial manufacturing, including associated logistical and operational infrastructure, mindful of evolving global regulatory frameworks. Ensure timely completion of all functional deliverables including reports and applicable quality and regulatory documents. 
  • Contribute to identify, select and manage Contract Manufacturing Organizations (CMOs)/Contract Research Organizations (CROs) for drug substance, drug product and analytical development (process/method optimization, cGMP manufacture and supply) in collaboration with the other CMC representatives to ensure continuum with DS and DP, in support of future, ongoing clinical and commercial supply programs. Lead, manage, supervise and coordinate the work of analytical CMOs/CROs, material suppliers, consultants, vendors and collaborators as applicable to meet bioanalytical development goals. Provide oversight of science-driven and phase-appropriate analytical method development, optimization, qualification, validation, and if needed transfer, activities at CMOs/CROs to perform in-depth physical/chemical characterization of complex biologics. Travel to CMO/CRO sites may be needed.
  • Lead the Bioanalytical CMC aspects of all regulatory section submissions and if needed represent the company as the Bioanalytical CMC expert in interactions with global regulatory authorities. 
  • Responsibility for all Bioanalytical CMC activities for overall compliance with global regulations ensuring that all CROs/CMOs use systems and processes in compliance with all relevant regulatory standards. Provide technical guidance during testing-related investigations at CMOs/CROs in collaboration with Quality.
  • Represent CMC in one or more project teams and actively contribute to define the CMC development plans with her/his CMC colleagues from Drug Substance and Drug Product, in alignment with the other functions involved in the projects. 
  • Maintain state-of-the-art knowledge of biologics analysis with the latest analytical technologies as well as emerging analytical development strategies, providing guidance and advice to the executive team shaping product development. Contribute to regulatory intelligence for the analysis of biologics products. 
  • Maintain and enhance a network of consultants, vendors, and suppliers to supplement internal capabilities, to adequately support active and future development programs and commercial products.
  • Provide oversight and technical guidance for the Bioanalytical CMC part in support of due diligence for potential in-licensing activities, external collaborations, and acquisitions. 
  • Contribute to build a world class CMC team for all analytical activities. 
  • Formulate, monitor and control budgets for the Bioanalytical part of the CMC and Manufacturing activities. 

Key Requirements:

  • Bachelor’s degree in a relevant subject (e.g. analytical chemistry, biochemistry, biotechnology, chemical engineering, biophysics) or related scientific discipline with PhD or Masters in science preferred.
  • Minimum 10-15 years of extensive industrial experience of complex therapeutic biologics (antibodies modalities notably) phase-appropriateanalytical development, especially early-stage, and has been an integral part, in a leadership capacity for a minimum of 3-5 years of steering products through to market, preferably with a demonstrated innovative approach. 
  • Possess expert knowledge and proven “hands-on” track-record in developing a wide range of standard analytical protein characterization and biophysical methods (e.g. HPLC-based methods, cIEF, capillary electrophoresis, LC/MS, peptide mapping, spectrophotometry, subvisible particles , light scattering, etc.) for protein sequence confirmation, identification and characterization of product variants, comparability evaluations... Capable to leverage and foster her/his existing network of experts’ relationships.
  • Strong grasp of statistical approaches for design-of-experiments (DoE) analytical method development, robustness testing, and data analysis.                       
  • Prior working experience in outsourcing and managing CMOs/CROs is highly preferred.
  • Previous experience serving as CMC analytical lead for multiple large molecule programs. 
  • Experience with microbiology would be a plus.
  • Demonstrated knowledge of relevant FDA and EMEA regulations and best industry practices related to CMC bioanalytical matters, and related experience (e.g. ICH/FDA/EMA/GMP) including audits/inspections, preparation, writing and submission of IND/CTA mainly and preferably also BLA/NDA/MAAs, and interactions with regulatory bodies.
  • Negotiation, influence, and strong project management and interpersonal communication skills that facilitate collaboration across functions and with consultants and CMOs/CROs, with a demonstrated ability to identify, execute and deliver value-creating solutions to the most complex of CMC issues. 
  • Ability to be innovative within constraints of cGMP environment with a drive to reduce cost-of-goods through innovative approaches.
  • A motivated self-starter, resilient, capable of hitting the ground running and excelling in a high growth, entrepreneurial business environment. Proven ability to take initiative in a technical, multicultural global working environment, leading by example while having an inclusive, collaborative style.

Hemab is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

As a healthcare company Hemab has an important responsibility to protect individual and public health. All roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

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Director, Analytical Development, CMC