Job SummaryLeads and manages ARx's PDP process. This includes development and scale up, tech. transfer and validation of formulations and manufacturing processes and packaging for producing specialty drug delivery products in a manner compliant with 21CFR211, the ARx PDP, and all other relevant CMC regulatory requirements.
Essential Functions:- Leads business in developing new products consistent with business priorities, customer needs and application requirements.
- Responsible for all aspects of PDP process and packaging development, scale-up, validation and tech. transfer.
- Manages Process Engineers associates during performance of a variety of tasks, which include but are not limited to, preparation and execution of project tasks in compliance with 21CFR211 Regulatory standards and the requirements of the ARx PDP.
- Works in close collaboration with Quality, Operations, Marketing and Clients to accomplish successful outcomes.
- Lead and manage the PDP Team during the design and execution of experiments, data collection and analysis, data interpretation using statistical analysis tools (SPC, ANOVA, Regression, etc.), and the generation of reports.
- Ensures that the PDP Team generate design records required to support product development consistent with the ARx PDP.
- Ensure establishment and maintenance of adequate records for formulas, processing methods and product construction standards; assures organization of technical information in frameworks which readily afford business organizational efficiency.
- Proficiently employs current software tools for communications, presentations, project tracking and statistical analysis (e-mail; spreadsheets; PowerPoint, Project Management, Experimental Design, Statistical Analysis tools, etc.).
- Effectively communicates with all other associates while maintaining the self-confidence and self-esteem of others; voluntarily assists other associates and communicates effectively to prevent problems from occurring.
- Leads problem-solving efforts and takes initiative to make changes through change-control procedures.
- Influences business strategies that have both divisional and corporate impact. Participate in strategic technology planning for business units and corporate platforms.
- Conducts all work activities in a safe, responsible and professional manner consistent with all Company Policies, Quality Systems Requirements and Relevant Regulatory Standards (e.g. 21CFR211).
- Contributes to IP strategy, enhancing the business's sustainable competitive advantage.
- Coordinate and supervise direct reports to ensure project tasks are assigned and executed as per expectation.
- Completes performance assessments and ongoing coaching of direct reports.
- Conducts disciplinary action and completes proficiency plans for improvement.
- Additional responsibilities as required.
Additional Responsibilities:- Builds cross-functional networks to achieve business objectives and proactively shares technology and knowledge responsibly, both internally and externally.
- Provides technical support to internal and external customers on process, equipment, and quality issues.
- Leads assigned deviation investigations and implements effective corrective and preventive actions.
- Participates in training; assists with and leads training, where applicable. Mentors team members and other associates to increase their functioning capabilities.
- Performs other duties and responsibilities as assigned.
Job Specifications:- Bachelor's degree in Science, Engineering, or technical discipline required; graduate degree preferred.
- Minimum of 8 years relevant industry experience (thin film, transdermal, process development).
- Ability to understand technical aspects of drug formulation and process technology required.
- Previous cGMP & related design record experience desired.
- Expert in design control processes including experience in Quality-By-Design (QbD)
- Familiarity with clinical trials & FDA regulatory filings desired.
- Previous experience in formulations, film casting and converting desired.
- Proven history of successful project management.
- Excellent team leadership and facilitation skills.
- Ability to oversee multiple projects simultaneously.
- Strong oral and written communications skills.
- Exceptional ability to manage detail in the context of overall project and business strategies; ability to make sound decisions balancing competing considerations.
- Works well under pressure ensuring tasks and goals are met.
- Previous experience with LEAN and SIX SIGMA desired.
