Director Pharmaceutical Development
11 - 15 years experience •
The Director Pharmaceutical Development serves as the functional leader responsible for directing formulation activities in relation to the development of the Company’s pipeline of generic pharmaceutical products. The Director will lead the formulation development team based at our Maple Grove, MN facility. In addition to leading a group of formulation scientists in supporting the company’s internal generic product development activities, this position will closely with other team members to provide oversight of external product development collaborations with various pharmaceutical development companies. This position directly manages the formulation laboratory and pilot scale-up facilities with regard to materials, equipment, operating procedures, budgets, resources, compliance to cGMP and company policies.
- Directs the formulation development team responsible for the development of generic drug products.
- Works collaboratively and effectively with external partners, collaborators, multiple nationalities and cultures to drive product development activities across the world. Manages oversight and interactions of API and formulation development with vendors such as API suppliers, CDMOs, Licensors, and other similar organizations.
- Prepares budgetary projections and justifications for departmental headcount, capital expenditures, purchased services, and raw materials.
- Allocates resources to best support dynamic and diverse generic drug development portfolio.
- Prepares departmental goals and objectives aligned with corporate objectives.
- Provides technical guidance to department staff in areas related to product development (e.g. characterization, formulation development, process development, clinical supplies manufacturing, technology transfer, process scale-up, DOEs and quality by design (QbD).
- Creates an innovative working environment conducive to developing generic product formulation approaches and manufacturing applications.
- Drafts, reviews, and approves Standard Operating Procedures (SOPs) and department guidelines.
- Ensures that department personnel are properly trained and follow all applicable company processes, guidelines, and SOPs.
- Coordinates activities of the formulation development group in conjunction withother groups within the Company (Chemistry and Analytical Sciences, Project Management, Clinical, Regulatory, Business Development, Legal, Technical Services, Operations, Integrated Quality Management) to provide technical guidance to ensure the timeliness and effectiveness of all development activities.
- Communicates effectively with executive management and keeps current regarding company and industry issues.
- Approves project plans and works closely with Project Management to implement and maintain plans. Ensures product development is conducted in a timely fashion in accordance with agreed upon timelines and milestones.
- Reviews technical data related to formulation and process development, as necessary.
- Drafts and reviews content to be included in ANDA submissions.
- Maintains a highly functional organization by planning and implementing training in areas such as safety, computer technology, formulation and materials, equipment and processes, project planning, time management, and communications. Implements and monitors all training programs required for new employees.
- Ensures staff is trained and qualified in all GMP/ DEA related issues.
- Represents Pharmaceutical Development during correspondence with FDA, as required.
- Reviews and approves in-process and finished product specifications.
- Supports due diligence activities.
Education and Experience Requirements:
PhD degree in pharmaceutics, chemistry, chemicalengineering or other related physical science and 10+ years of pharmaceutical development experience. All candidates must have a minimum of 7+ years of experience in a supervisory capacity. All candidates must have at least 5+ years of managing and leading outsourced pharmaceutical development projects. Experience with diverse dosage forms and routes of administration highly preferred. Experience with peptides, proteins or other large molecules is also preferred but not required.
Travel: Up to 50%
Other skills and abilities required:
Strong interpersonal, collaboration, organizational, leadership, and presentation skills. Ability to think strategically and tactically. Thorough understanding of chemical and physical properties of active ingredients and excipients as they relate to formulation, process and drug delivery. Working and theoretical knowledge of pharmaceutical ingredients, manufacturing, processing and testing equipment, advanced technologies, and delivery systems. Ability to develop formulations, processes, and generic pharmaceutical products.
Experience with design of experiments (DOE) and experimental planning. Current understanding of Good Manufacturing Practices (GMP). Strong understanding of budget development, forecasting, and expense management. Reasonable understanding of intellectual property law as it relates to drug delivery systems, solid dosage forms, formulation and process technologies, and the ability to evaluate prior art. Computer skills with knowledge of Microsoft Office programs. Project management skills with the ability to direct and coordinate a group of scientists, each having multiple projects, in an effective, productive fashion. Excellent management and interpersonal skills with the ability to maintain a team of highly motivated and productive scientists.
Ability to effectively interact with personnel in other departments. Excellent verbal and written communication and presentation skills, inducing both technical and non-technical information. Ability to effectively interact with multiple nationalities and cultures.
Upsher-Smith Laboratories, Inc. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, Inc. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.
Job ID 7068