Description:
Company Information:

Breakthrough Careers!
A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality.

Position Summary:

The Formulation Sciences Department is seeking a Pharmaceutical Scientist to be responsible for oral formulation and process development of small-molecule therapeutics. Specific responsibilities include supervising a staff of scientists and engineers, managing the cross-functional development and outsourcing operations, allocating department resources, managing the outsourcing budget, and reviewing regulatory documents. The candidate will participate in multidisciplinary CMC teams.

Duties and Responsibilities:

. Leads Formulation Science group, which is responsible for oral-dosage formulation development and clinical trial material manufacturing
. Ensures consistent application of sound scientific and engineering principles and industry best practices
. Works closely with other drug product development functions (esp. Analytical Development) to ensure the resources are allocated to meet project goals
. Works closely with Process Chemistry and Supply Operations to ensure that drug substance and CTM supply/demand plans are established and executed
. Works closely with Divisional Business Operations functions to ensure proper execution of budgeting and contracting processes;
. Manages outsourcing budget
. Monitors and evaluates vendor performance with input from relevant CMC functions; coordinates and oversees corrective development plans and remediation effort
. Influences CMC regulatory strategy and reviews regulatory documents
. Participate on multidisciplinary CMC and project teams

Qualifications:

Preferred Qualifications:
. Ph.D. in Pharmaceutics, Chemical Engineering, or related discipline
. At minimum, 8 years of solid-dosage formulation development experience
. At minimum, 3 years of supervisory experience
. Proven record of successful people and project leadership the ability to develop collaborations across functions and teams; to negotiate; and influence a diverse set of stakeholders
. Knowledge of FDA and ICH guidelines and IND/CTD submission processes
. Development of oncology therapeutics
. Experience with outsourcing management
. Experience with preformulation is a plus
. Experience with NDA submission process is a plus

Basic Qualifications:
. Ph.D. in Pharmaceutics, Chemical Engineering, or related discipline
. At minimum, 8 years of solid-dosage formulation development experience
. At minimum, 3 years of supervisory experience