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

• Scientific curiosity and willingness to learn
• Excellent leadership and collaboration skills
• Demonstrated understanding of pharmaceutical process and/or product development
• Strong analytical and problem-solving skills
• Excellent verbal and written communication skills
• Excellent organizational skills and attention to detail
• Excellent time management skills with a proven ability to meet deadlines
• Demonstrated ability to collaborate and lead cross-functional teams
• Ability to function well in a high-paced and at times stressful environment
• Ability to prioritize tasks and to delegate them when appropriate
• Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside of the company
• Accepts feedback from a variety of sources and constructively manages conflict
• Proficient with Microsoft Office Suite or related software

Education and Experience

• B.S. in Science or Engineering discipline with 20+ years experience
• M.S. in Science or Engineering discipline with 18+ years experience
• PhD in Science or Engineering discipline with 15+ years experience
• Demonstrated experience in technical focus areas (formulation sciences, analytical sciences, process engineering, drug product development)
• Extensive experience developing solid oral dosage forms for clinical and commercial products
• Extensive tablet development experience is a must, including expertise of basic materials characteristics and unit operations such as blending, granulation, compression and coating operations
• Experience with API characterization and technology selection for enabled formulations
• Experience with pre-clinical formulation development

Physical Requirements

• Prolonged periods of sitting or standing at a desk and working on a computer
• Must be able to lift up to 15 pounds regularly and up to 30 pounds occasionally
• Motor skills required for basic laboratory operations (pouring liquids, using utensils to transfer powders, visual assessments)
• Adheres to consistent and predictable in-person attendance

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. Seran 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. Seran 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 Seran BioScience are located at 63047 Layton Ave, Bend, OR 97701.