Albireo is a clinical-stage biopharmaceutical company focused on the development and potential commercialization of novel bile acid modulators to treat orphan paediatric liver diseases and other liver or gastrointestinal diseases and disorders. We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs.
Odevixibat is a potent and selective inhibitor of the ileal bile acid transporter (IBAT), sometimes also 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.
Odevixibat has the potential to become the first approved pharmacologic treatment for patients with PFIC. The Company intends to complete regulatory filings in the EU and in the U.S. no later than early 2021, in anticipation of potential regulatory approval, issuance of a rare pediatric disease priority review voucher and launch in the second half of 2021, if approved. The Company also plans to initiate a pivotal Phase 3 trial of odevixibat in Alagille syndrome by the end of 2020, and to continue enrolling patients in the BOLD pivotal Phase 3 trial of odevixibat in biliary atresia. Albireo continues to progress its pipeline and expects to complete IND-enabling studies for a new preclinical candidate this year.
The U.S. Food and Drug Administration (FDA) has granted to the odevixibat PFIC program or elements of it fast track, rare paediatric disease and orphan drug designations. The European Medicines Agency (EMA) has granted odevixibat orphan designation, as well as access to the PRIority MEdicines (PRIME) scheme for the treatment of PFIC. Its Paediatric 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 commercialise Odevixibat in the US, Europe & Canada and will partner in remaining regions.
Job Title: Senior Manager, Drug Product Development
Reports To: Director/Senior Director, Drug Product Development
Location: Boston, MA
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
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
Equal Opportunity Employer
All applicants should be legally entitled to work for any employer in the U.S.
Note to employment agencies: Please do not forward any agency resumes.