Director, Analytical Development

Job Description

Job Title:             Director, Analytical Development

Reports To:          VP, Pharmaceutical Development

Location:               Boston, MA

Position Summary:

Reporting to the VP, Pharmaceutical Development, the incumbent will be responsible for providing technical and managerial leadership, project management and oversight of analytical method development and validation activities for drug substances and drug products in support of Albireo’s clinical programs across all phases of development.

Key Duties and Responsibilities:

  • Head the Analytical Development function
  • Develop technically sound and validatable analytical methods
  • Establish analytical development strategies and operational plans across a portfolio of projects, and ensure that they are aligned with the strategic and operational objectives of other functions, and of the company
  • Participate in the selection and qualification of third-party suppliers for the manufacture and testing of drug substances and drug products
  • Oversee analytical method development and validation at third-party service providers
  • Preparation of supporting regulatory documentation
  • Collaborate with other functions to assure compliance with applicable GxP and global regulatory requirements
  • Ensure budget, schedules, and performance requirements are met
  • May hire, mentor, and develop staff according to the future needs of a growing company

Qualifications:

  • Ph.D in analytical chemistry or related discipline
  • A minimum of 8 years’ industry experience in analytical development, specifically for small molecule drug substances, and solid oral dosage forms
  • Strong knowledge of US and EU cGMP requirements and best practices relating to drug substances and drug products
  • Strong knowledge of analytical testing and validation requirements across all phases of drug development from initial regulatory filings through registration, validation and launch
  • Experience in managing multiple third-party contract manufacturers and associated service providers
  • 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

JOIN ALBIREO

Equal Opportunity Employer

Albireo Pharma, Inc. is an equal opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

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.  Albireo is not responsible for any fees related to resumes that are unsolicited.