Sr Director New Product Development

at  TOLMAR Inc

KNOWLEDGE, SKILLS & ABILITIES

• Must have experience managing a sizeable research team and working closely with early stage, analytical, device, manufacturing and quality functions in a plant environment.
• Broad knowledge of injectable drug delivery platforms, controlled-release technologies, biodegradable polymers, aseptic processing, 505(b)(2) regulatory pathway, and cGMP regulations highly desirable.
• Demonstrated experience in formulation of long acting / extended release parental products, including formulation development utilizing Quality by Design (QBD).
• Demonstrated scientific project management skills to establish strategic goals and to prioritize, plan, delegate, and evaluate deliverables.
• Excellent verbal and written communication and presentation skills with the ability to communicate scientific/technical in an easy to understand manner.
• Strong leadership skills; creating a dynamic environment that fosters transparency, collaboration, and innovative thinking.
• Excellent problem-solving skills; ability to analyze complex sets of data and make sound decisions and recommendations in a timely manner.
• Strong intellectual capabilities; conceptualizing and developing new and complex injectable technologies.
• Entrepreneurial mindset; can identify opportunities and execute.
• Self-motivated and proactive.Excellent coach and mentor; passion for developing high-performing teams.

EDUCATION

Required

• PHD or better in Science or related field

PURPOSE AND SCOPE

Direct, lead and monitor the product development lifecycle from Early Stage exit through regulatory filing and product launch. This position is responsible for the development of scientific plans, including the formulation and process development functions. This position functions as the scientific liaison to business partners and thought leaders in areas of interest to the company. This role will provide critical input to the company’s new product strategies and application of its long-acting Injectable technology to meet the growth goals of the company.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Serve as a product development leadership team member and act as an internal technical and scientific partner to the Analytical, Clinical, Regulatory, Legal, MS&T, EPMO, Commercial, Quality, Finance, and Business Development functions.
• Create long-range development plans for the formulation and process development functions in conjunction with other departments to meet the company’s growth goals.
• Define goals per the company strategy and translate these goals into operational project plans.
• Coordinate, prioritize, and manage pipeline projects from early stage exit through commencement of clinical studies and regulatory filing, ensuring that timelines, resources, and priorities for pipeline projects are delivered promptly.
• Nurture a culture of innovation, ensuring that technology and formulations achieve novel, effective, and patentable inventions.
• Hire, train, develop, evaluate, and manage staff as necessary, in accordance with company policies and federal/state regulations, with input from the Human Resources department.
• Foster a strong sense of communication and collaboration within the organization.
• Ensure projects are managed in a structured, organized, and cost-efficient manner to meet timelines, budgets, and quality standards.
• Set appropriate goals and performance standards for the team and provide an atmosphere that fosters innovation and compliance.
• Participate in decisions regarding internal or external development paths for regulatory filings and approval. Assist in the selection and management of CMO’s and CRO’s.
• Work collaboratively with the IP team to enhance and expand the company’s assets.
• Foster and maintain compliance expectations with quality, safety, confidentiality, and corporate integrity standards/policies.
• Develop a budget for the formulation and process development functional areas, manage and allocate resources, and monitor expenditures.
• Stay abreast of technical knowledge and trends in the controlled-release injectable drug delivery sector.
• Ensure that all regulatory and internal policies are followed.
• Perform other related duties as assigned.