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Biologics CMC Project Leader
Il y a 2 mois
About Corteria Pharmaceuticals
Corteria Pharmaceuticals is a privately held clinical-stage company that develops first-in-class drugs in subpopulations of heart failure and obesity. Our programs aim to treat well defined heart failure subpopulations (worsening heart failure, acute heart failure with hyponatremia, right heart failure) and obesity with co-morbidities.
We develop several drug candidates on clinically validated targets: CRF2 and vasopressin
• CRF2 projects: endogenous CRF2 ligands (urocortin 2 or stresscopin) have been validated in heart failure patients but their very short half-life which makes them unsuitable for subchronic use. Our strategy is to develop a potent, selective, long-acting CRF2 agonists suitable for subcutaneous administration for the treatment of worsening heart failure and obesity.
· Vasopressin project: therapeutic targeting of vasopressin requires the blockade of its 3 receptors (V1a, V1b, V2) which cannot be achieved today by a small molecule approach. To overcome this issue we are developing a neutralizing human monoclonal antibody directed against vasopressin to provide a therapeutic solution to hyponatremic acute heart failure or ADPKD patients.
We are seeking a skilled and experienced Biologics CMC (Chemistry, Manufacturing, and Controls) Project Leader to join our dynamic team. The candidate must have an extensive expertise in biologics formulation and drug product process development, scale up, and technology transfer. He/She will support the manufacturing of our antibody and actively engage with different contract manufacturing organisations to manage the manufacture and testing of our antibody according to the Corteria’s development plan. This role requires a combination of CMC knowledge, leadership abilities, and strategic thinking.
Missions and Responsibilities:
These may include but are not limited to:
- Establish the request for proposal, identify and qualify the different CROs according to GMP practices
- Define the QTPP (Quality Target Product Profil) of the antibody
- Quality control and validate the different technical documents (protocols, product specification form, certificate of analysis, reports…) of the different CROS
- Manage the different batches (stability, retest, release etc)
- Prepare and update the IMPD/IND and answers to CMC regulatory authorities’ questions
- Establish in collaboration with the clinical team the drug product need and supply of the sites to support on time the clinical trials
- Lead external cross-functional teams in the planning and execution of CMC activities for biologic drug development project
- Coordinate with internal and external stakeholders to ensure alignment on project goals, budget and milestones
- Manage and track project progress, identifying and addressing potential obstacles and risks
- Ensure compliance with regulatory requirements and industry standards throughout the product development process
- Collaborate with manufacturing, quality control, regulatory affairs, and other departments at Corteria to ensure successful project outcomes
- Communicate project updates and findings to senior management and key stakeholders
- Provide technical expertise and guidance on biologics manufacturing processes and technologies
Education and Experience:
Required:
- The candidate should have experience with early and late-stage development for therapeutic biologics for at least 15 years in pharmaceutical companies.
- PharmD or PhD with advanced degree in a relevant scientific discipline (e.g., biology, biochemistry, biotechnology)
- Trained to GxP practices
- The candidate should be very rigorous and well organized with excellent communication and leadership skills
- Fluent in English
