Director, Drug Product Development

Director, Drug Product Development

Sern BioScience is searching for a Director to join our Drug Product Development team! The Director of Formulation Science and Drug Product Development will be responsible for leading a team to develop and deliver novel pharmaceutical therapies. The team is responsible for pre-formulation assessments and technology selection, drug product design and formulation development for both the drug product intermediate and drug product. Problem statements include both pre-clinical and early phase clinical development of formulations and dosage forms. Projects include, but are not limited to, pharmaceutical final-dosage forms such as tablets, capsules, sachets, suspensions, multi-particulates, pediatric forms and drug product intermediates such as amorphous solid dispersions, micronized or nanoparticle forms, and lipid formulations. The team primarily focuses on development of formulations for oral delivery.

The ideal candidate will be skilled in and have hands-on experience with unit operations associated with oral solid dosage forms including dry granulation, wet granulation, encapsulation and compression. Experience with formulation development and bench-scale prototyping in addition to scale-up and process scale manufacturing of solid dosage forms is required. Experience with cGMP manufacturing, or minimally the transfer of processes into cGMP manufacturing is preferred. An emphasis on understanding and leveraging material properties throughout formulation and process development is desired. The Director is expected to provide technical guidance and support to the team to ensure strategic and efficient work plans and experimental designs with a high standard of scientific excellence in design, execution, analysis and interpretation of experimental work.

Duties and Responsibilities

• Provides strategic vision for organization & group
• Delegation & oversight of new projects
• Contributes to defining the technical strategy for new projects
• Contributes to strategy for the development and implementation of innovative technologies
• Contributes to company strategy, budgeting and forecasting
• Interfaces as a technical SME with clients when appropriate
• Identifies and implements continuous improvements for operational excellence
• Makes recommendations for capital expenditure to Executive Management
• Works closely with key stakeholders in the Process and Product Development team and cross-functionally to support tech transfer processes
• Authors / reviews / approves project proposals and budgets
• Responsibilities may increase in scope to align with company initiatives
• Performs other related duties as assigned

Required Skills and Ability

Education and Experience

Physical Requirements

Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Benefits Summary :

Sern employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Sern covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees' wellbeing, along with access to pet insurance.

The Corporate Headquarters of Sern BioScience are located at 63047 Layton Ave, Bend, OR 97701.