ARx Director of Product and Process Development

Adhesives Research; Glen Rock (York County); On-site; USD 120,000 - 160,000; Full time

Job summary

Adhesives Research seeks a Director of Product and Process Development to lead PDP activities for drug-delivery product development. You will drive scale-up, tech transfer, validation and packaging development, while coordinating with Quality, Operations, Marketing and clients to achieve strong outcomes.

The role requires 8+ years in process development, expertise in formulation technology, and familiarity with 21 CFR 211.

Qualifications

• 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.
• 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.

Responsibilities

• Leads PDP process development, scale-up, validation and tech transfer.
• Manages packaging development, scale-up, validation and tech transfer.
• Supervises Process Engineers during project tasks and compliance with 21CFR211.
• Collaborates with Quality, Operations, Marketing and Clients for successful outcomes.
• Leads experiments, data collection and analysis using SPC, ANOVA, Regression, etc.
• Ensures design records support product development per ARx PDP.
• Maintains records for formulas, processing methods and product construction standards.
• Uses software tools for communications, presentations, project tracking and statistics.

Skills

Leadership

Project management

Communication

Analytical thinking

Problem solving

Education

Bachelor's degree in Science/Engineering/technical

Graduate degree preferred

Tools

Excel

PowerPoint

Project management software

Statistical analysis tools

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

ARx Director of Product and Process Development

Full Time 1st/Mid lvl Off&Mng Glen Rock, PA, US

Job Summary

Leads 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.
• 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.