Albireo Pharma Overview:
Albireo is a clinical-stage biopharmaceutical company focused on the development and potential commercialization of novel bile acid modulators to treat orphan pediatric liver diseases and other liver or gastrointestinal diseases and disorders. Albireo has deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs.
The company’s first commercial launch will be Odevixibat, which is a potent and selective inhibitor of the ileal bile acid transporter (IBAT), sometimes referred to as the apical sodium dependent bile acid transporter (ASBT), that has minimal systemic exposure at therapeutic doses and acts locally in the gut.
Albireo is developing Odevixibat initially to treat patients with PFIC, a rare genetic liver disease, and plans to consider additional development in other pediatric cholestatic liver diseases and disorders in the future. Our Phase 3 program in PFIC includes a single randomized, double-blind, placebo controlled, multicenter clinical trial and an open-label long-term extension study. The double-blind trial, called PEDFIC1, is underway with data read out anticipated in mid- 2020.
The U.S. Food and Drug Administration (FDA) has granted to the Odevixibat PFIC program or elements of its fast track, rare pediatric disease and orphan drug designations. The European Medicines Agency (EMA) has granted Odevixibat orphan designation, as well as access to the Priority Medicine’s (PRIME) scheme for the treatment of PFIC. Its Pediatric Committee has agreed to Albireo’s Odevixibat Pediatric Investigation Plan for PFIC. Both FDA and EMA also have granted orphan drug designation to Odevixibat for the treatment of Alagille syndrome and primary biliary cholangitis. Albireo will commercialize Odevixibat in the US, Europe & Canada and is pursuing potential partners in remaining regions.
Reporting to the Director/Senior Director, Drug Product Development, the incumbent will be responsible for providing technical leadership and operational oversight of drug product formulation development and manufacturing activities in support of Albireo’s clinical programs across all phases of development.
Key Duties and Responsibilities:
- Lead operational plans for drug product development across a portfolio of projects, in alignment with the strategic and operational objectives of other functions, and of the company
- Manages the development and implementation (including experimental design, data interpretation and documentation) of patient-centric drug products, with scaleable and robust manufacturing processesacross all stages of development
- Manages drug product formulation development and manufacturing operations at third-party service providers in a 100% outsourced business model
- Manages technical transfers and implementation of manufacturing processes at additional/alternate third party service providers, as appropriate
- Participate in the qualification of third-party suppliers for drug product formulation development and manufacturing
- Contribute to the preparation of supporting regulatory documentation
- Collaborate with Quality Assurance and Regulatory Affairs to assure compliance with applicable GxP and global regulatory requirements
- Ensure alignment of all activities with budget, schedules, and performance requirements
- Master’s degree or Ph.D in pharmaceutics, chemical engineering or related discipline
- A minimum of 4 (Manager) or 6 (Senior Manager) years’ industry experience in drug product process development and manufacturing of oral liquid and solid dosage forms
- First-hand experience in successfully scaling up and executing drug product manufacturing processes on pilot plant and/or commercial manufacturing scales
- Familiarity with US and EU cGMP requirements, ICH guidelines and best practices relating to drug product
- Good knowledge of drug product formulation development and manufacture across all phases of drug development from initial regulatory filings through registration, validation and launch
- Prior experience managing outsourced activities at international CMOs
- Excellent communication skills, both verbal and written, as demonstrated through prior work experience keeping key stakeholders and management informed of status, issues and recommended solutions
- Excellent planning and organizational skills
- Ability to think intuitively and problem solve
- Ability to be successful in a fast pace, small, start-up environment
- Able to manage shifting priorities
To Apply: https://www.jobg8.com/ATSApply.aspx?O%2bwhDB%2f2aAZBqqpVobDhpQq