A leading Contract Manufacturer in the Pharmaceutical industry is seeking to bring on a Director of Product Developement. This position is customer-facing bringing new business through to commercialization and providing technical support for ongoing manufacturing and packaging operations of commercialized products.
The position is responsible for the implementation and execution of drug product process development and formulation optimization plans in support of strategic initiatives of the company, including non-sterile products, through the effective management of department's staff, resources, and capital for both new and existing business.
This position is responsible for providing and maintaining suitable equipment required to support all business groups and functions operating on the Rochester site. It is the responsibility of this position that proper equipment is available at all times for the support of the organization’s business goals. All equipment and processes must also be validated and maintained such that they are in compliance with all regulating authorities including; FDA (and applicable authorities worldwide) DEA, OSHA, NFPA, DEC, and any/all applicable national, state, and local authorities for the proper manufacturing and packaging of pharmaceutical products.
Responsibilities of the position include management of staff, capital, and resources for the: production of phase III/IV clinical material, manufacture and packaging of ICH stability program, commercial formulation development & optimization, scale-up, commercial process development & optimization, technology transfer, preparation of documentation for regulatory filing and input for commercial validation. Furthermore when GMP manufacture is required, management of the pilot plant in a c-GMP compliant state for the above mentioned activities.
This position collaborates with other internal functional areas as the primary liaison within the organization, as well as Operations, QA and Regulatory, Business Development and global development colleagues.
ESSENTIAL DUTIES / RESPONSIBILITIES:
New Commercial Products Implemented
- Evaluates technical ability to deliver new business. Oversees the compilation of all scope, resource, and cost information for new products. Applies manufacturing and statistical methods to estimate manufacturing requirements, potential, and cost of product to be developed.
- Oversees the development of product formulations that utilize effective manufacturing processes and ensure product safety.
- Accountable for ensuring delivery of product development (e.g. products, methods and processes) outcomes consistent with customer agreements. Defines critical milestones, deliverables and to affect final outcome.
Customers are Confident in the Company’s Ability to Deliver Products
- Collaborates as the primary liaison within the organization between Business Development, Supply Chain, Operations, Validation, Engineering and QA to ensure development plans for new business opportunities and products within Product Development.
- Supports the accomplishment of company objectives and specifically is able to provide the “Big Picture” analysis/advice in regards to products, processes and programs.
- Ensures the effective documentation, transfer and sharing of product and formulation knowledge across the organization.
- Oversees process development and regulatory compliance strategy and directs product development programs.
- Provides leadership and support for the successful achievement of all new business innovation initiatives and programs to assure successful transition to product commercialization. Confers with customers to resolve technical issues, as required.
- Ensures application of effective project management methodologies; and organizes cross-functional teams to support delivery of product development activities.
Innovations that are Aligned with Business Goals
- Researches, evaluates and recommends potential development strategies that build on the organization’s core capabilities to drive growth in current customer business as well as identify targets for new business.
- Identifies and drives implementation of opportunities for manufacturing efficiency and/or product cost savings through cost benefit analysis techniques (ingredient substitutions, etc.). Ensures any product risks are mitigated.
- Recommends methods for improving implementation by reducing wasted materials, and utilizing reorganization of work flow.
- Supports the means to improve laboratory productivity via enhancements to systems, processes, training, staff development and the implementation of new laboratory technologies.
Capital Projects Achieve Identified Goals
- Develops annual and long range department budgets for both capital and expense spending.
- Responsible for the delivery of all major capital projects on the Rochester site. Project execution includes; development of business cases and requests for funding, development of specifications and designs, development of project plans, bidding and award of bids, construction management, and commissioning and qualification.
Sustainable Operational Improvements
- Develops and implements improvement plans to create operating efficiencies, eliminate redundancies, and improve business results. Ensures processes are documented and standardized.
- Utilizes internal and external data to make analytical observations and recommendations that addresses the implications of policy changes, new business strategies; the competitive environment; changing demographics; and other trends that impact organizational performance.
- Identifies the impact of technology on business processes to ensure that it is used to maximum advantage in enabling process analysis, decision-making and reporting. Involves employees when implementing new technology and ensures they receive necessary training and follow-through.
- Ensures the application of a system for achieving and sustaining success through customer focus, process management and improvement, and the wise use of facts and data. The primary goals shall be focused around metrics to validate efficiency, adding to margins and growth of the business.
Improved Organizational Capabilities
- Pipeline of Leadership Talent in Key Roles: Analyzes the skills and capabilities of the functional area; identifies future workforce requirements; and identifies a means to close any gaps. Ensures processes are in place for unleashing the full potential of others by providing needed resources, coaching, experiences and other support to place the right people in key roles and continuously upgrade their skills and knowledge.
- Organizational Structure: Develops an organizational structure that supports the retention and development of staff to deliver a high level of services, as well as offers career development for high performers/ high potentials.
- Employees Aligned to Vision, Direction and Goals: Aligns priorities with the direction and priorities of the broader organization. Diagnoses whether assigned functional areas are performing at full potential and ensures communication cascades down through the organization. Breaks down organizational silos, bridges communication gaps, and engages the employees they manage so the entire workforce can understand how the company operates and how each person can contribute to the company’s success.
- Champion Change & Innovation: Ensures an environment that encourages fresh perspectives, innovative, breakthrough ideas and new paradigms that create value in the marketplace. Initiates, sponsors, and implements organizational change.
- B.S. with 14+ years of pharmaceutical industry experience in formulation development, process development and/or manufacturing; with at least seven years in a senior leadership role.
- Experience in a CMO desirable.
- Solid understanding of pharmaceutical dosage forms including controlled release drug delivery technologies.
- Experience with transitioning development processes into manufacturing scale.
- Areas of expertise should include most, if not all of the following: regulatory affairs and compliance, quality assurance and controls, validation, technical services, and an in-depth knowledge of at least one scientific field related to pharmaceutical sciences.