Director, Drug Product Development jobs in United States
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Serán BioScience · 1 week ago

Director, Drug Product Development

Serán BioScience is searching for a Director to join their Drug Product Development team. The Director will lead a team to develop and deliver novel pharmaceutical therapies, focusing on formulation development for oral delivery and ensuring high standards of scientific excellence in design and execution of experimental work.

Biotechnology
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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

Qualification

Formulation developmentSolid dosage formsCGMP manufacturingAnalytical skillsLeadership skillsCollaboration skillsProblem-solving skillsTime managementMicrosoft Office SuiteScientific curiosityCommunication skillsOrganizational skills

Required

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
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
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
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 predicable in-person attendance

Preferred

Experience with cGMP manufacturing, or minimally the transfer of processes into cGMP manufacturing
An emphasis on understanding and leveraging material properties throughout formulation and process development

Benefits

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
Serán 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
Access to pet insurance

Company

Serán BioScience

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At Serán, Our mission is to provide optimized drug development and manufacturing services for our clients, from discovery to the clinic.

Funding

Current Stage
Growth Stage

Leadership Team

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Dan Smithey, PhD
President, CEO and Founder
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Company data provided by crunchbase