Full Time
Maryland
Posted 2 years ago

Principal/Senior Principal Scientist/Engineer, Small Molecule Drug Product Development

What You’ll Do

Champion and lead tech transfer to clinical and initial commercial manufacturing sites
Manage a team of scientists and engineers, hands-on laboratory staff, and clinical manufacturing activities
Development of personnel, timelines, and budgets to meet the needs of a rapidly evolving portfolio of clinical candidates
Ensure completion of drug product sections of filing documents (IND, IMPD, NDA) and supporting documentation
Development of new drug product technologies and business processes to drive future innovations. Evaluation and implementation of new and sustainable drug product technologies as needed to support the development pipeline in support of ongoing life-cycle management.

Who You Are

You have a significant track record of success in the development and manufacture of oral solid dosage forms. You have strong problem-solving abilities, organizational skills, and an ability to work cross-functionally with internal and external partners.

Qualifications

Required Skills

Principal Scientist/Engineer
PhD in Chemical Engineering, Chemistry or Pharmaceutical Sciences with minimum 9 years’ experience in oral solid dosage form development
Senior Principal Scientist/Engineer
PhD in Chemical Engineering, Chemistry or Pharmaceutical Sciences with minimum 12 years’ experience in oral solid dosage form development
Demonstrated experience with the development of oral solid dose formulations and processes from bench to pilot scale including transfer to commercial sites
Experience running equipment and unit operations required for oral solid dose manufacturing (cGMP and global markets)
Experience designing, executing, and filing process validation experiments
Experience working in late-stage development or commercial manufacture
Experience managing a team of scientists and engineers
History of publishing patents and scientific articles in peer-reviewed journals

Preferred Skills

Familiarity with parenteral formulation development, continuous DP manufacture, process modeling, and technology transfer is a plus

To apply for this job please visit orbiterrecruiting.com.