Principal Scientist, Biologics Pivotal Formulation & Process Development

Описание вакансии

The Principal Scientist, Biologics Pivotal Formulation and Process Development role is part of the collaborative and interdisciplinary CMC development team aiming to use state-of-the art technologies and innovative methodologies to advance medicines into the clinic. The success candidate is expected to bring relevant technical expertise, contribute to key functional strategies, and serve as drug product leads on PDM (Pharmaceutical Development & Manufacturing) project teams. S/he will have opportunities for career growth through acquisition of new skills, experiences, and professional relationships in a fast-paced and resource-rich environment.

Responsibilities:

• Lead key elements of complex programs, such as portfolio projects, department initiatives, scientific collaborations, new technology assessments, and workflow optimization to help the department reach its goals.

• Design and execute formulation and drug product process development work packages for biologics, to support pivotal formulation development, drug product manufacturing, and clinical in-use evaluations.

• Demonstrate deep understanding of analytical, biophysical characterization, or process development techniques; bring new capabilities; lead by example for lab executions

• Fully embrace data integrity and good documentation practices for data and report generation; critically review internal and external documentations.

• Work with functional leaders to develop a functional handbook to pursue business process and technical excellence.

• Represent function and work collaboratively on cross-functional teams to support project team strategy and regulatory filings.

• Drive innovation and continuously grow technical expertise; influence internally and externally through publication, presentations, and industrial collaboration representation.

• May coach direct reports.

Basic Qualifications:

• PhD / PharmD with 5+ years of relevant experience

• MA / MS degree with 8+ years of relevant experience

• BA / BS degree and 10+ years of relevant experience

• Degree in Chemical Engineering, Bioengineering, Pharmaceutical Science, or related fields

• Industry experience in biologics CMC development

Preferred Qualifications:

• End-to-end experience of biologics formulation and process development, including both early- and late-stage development experiences.

• Experience of IND and/or BLA fillings.

• Expertise in lyophilization cycle development and GMP drug product fill and finish is highly desired.

• Working knowledge of lab automation, data science, and knowledge management.

• Hands-on in lab execution and has experience of training junior members.

• Publication and external presentation track records demonstrating strong technical innovation capabilities and industrial influence.

• People management experience is strongly desired.

• Experience working with contract development and manufacturing organization is highly preferred.