Fellow, Formulation Sciences
We Aspire to Cure Cancer! Millennium is a leading biopharmaceutical company focused on oncology that combines the agility, ideals and camaraderie of a start-up with the resources of Japan's largest pharmaceutical company. The result is a creative, entrepreneurial environment where quality science and making a difference in patients' lives are the priorities. Here, employees who share a drive and commitment to innovation for the benefit of oncology patients find their ideas, experience and contributions are valued and rewarded. Millennium offers great benefits, a friendly and respectful atmosphere, and a culture that promotes flexibility between work and life and encourages employees to give back to their community.
The Formulation Sciences Department is seeking a Pharmaceutical Scientist with a proven track record of leadership and technical accomplishments to contribute to oral and parenteral formulation and process development of small-molecule therapeutics; lead process validation of two late-stage drug products; and contribute strategically to global integration efforts.
* Mentor and coach scientific staff with formulation and process design and validation of solid oral and parenteral dosage forms by applying scientific principles and working in the process laboratory
* Provide leadership role in process understanding and validation for oral and parenteral dosage forms.
* Ensure consistent application of sound scientific and engineering principles and industry best practices
* Work closely with other drug product development functions, Tech Ops, and investigational and commercial manufacturing sites to transfer knowledge and processes
* Influence CMC regulatory strategy and review global regulatory documents
* Participate on multidisciplinary global CMC teams
* Contribute strategically to global integration and outsourcing efforts
* Ph.D. preferred in Pharmaceutics, Chemical Engineering, Chemistry, or related discipline and a minimum of 12 years of solid-dosage and parenteral formulation development experience; or MS in same fields with a minimum of 20 years of experience.
* At minimum, 5 years of supervisory experience
* Proven record of successful people and project leadership
* Must have scientific and technical expertise as evident by publications, patents, awards/honors and credibility at professional societies.
* Must have evidence of successful utilization of scientific and technical principles in negotiations of business goals with internal management, cross-functional team, regulatory agencies., and a diverse set of stakeholders
* Knowledge of process and product understanding, process validation, QbD, and risk assessments
* Knowledge of FDA. EMA, and ICH guidelines and IND/CTD submission processes
* Experience with outsourcing management
* Experience with preformulation is a plus
To apply for this position, please CLICK HERE