Vice President, Product Development 8/1/2020
Pacira Pharmaceuticals Inc
San Diego, CA
JOB DESCRIPTIONAPPLY DESCRIPTION
Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.
The purpose of this position is to provide management and leadership to the pipeline product development team, technical transfer of DepoFoam manufacturing processes and provide technical expertise in support of commercial manufacture.
Essential Duties & Responsibilities:
* Provide leadership in development of pipeline formulations and manufacturing processes, from the laboratory stage through scale up, pilot plant, validation and ongoing commercial scale manufacturing
* Provide an oversight to technical transfer of manufacturing processes from the Science Center Campus to CMOs and new in-house capabilities
* Manage the development and implementation of processes, technologies and products to achieve cost effectiveness and improve quality
* Provide expertise in the design of new equipment, establishing operating equipment specifications, improvement of manufacturing techniques and new process equipment production
* Provide technical expertise and guidance in support of the establishment and maintenance of the critical supplier base to ensure quality, contingency supply and cost optimization
* Support Operations, Quality and Clinical departments to ensure manufacture and release of clinical trial material and delivery to clinical sites
* Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
* Act as technical advisor to business development, operations management and Regulatory Affairs in support of product troubleshooting, assessment of acquisition opportunities and the authoring of CMC filing sections
* Use professional scientific concepts and company policies and procedures to solve a wide range of difficult problems in imaginative and practical ways
* Participate in the development of patent applications
* Ensure and participate in the professional development of own and cross functional teams
Directly supervise product development departments including Formulation and Process Development. Assume additional responsibilities where appropriate and as needed given the evolution of the company.
The incumbent works closely with Manufacturing, Quality, Reg. Affairs, Clinical, Medical, Business Development and Marketing management at products transition from early formulations development work to large scale manufacturing operations, and serves as a key member of the CTO s leadership team.
Education and Experience:
* 10+ years of relevant pharmaceutical development experience
* PhD degree in Chemical Engineering, Pharmaceutics, Chemistry or equivalent
Knowledge, Skills, and Abilities:
* Deep understanding of CMC from scientific, process, quality and regulatory perspectives
* Demonstrated leadership skills driving programs and significant organizational objectives to successful outcomes
* Ability to understand and direct scientific efforts at tactical levels and willing to provide hands-on assistance when appropriate
* Excellent planning, organizing and execution skills required. Provide a strategic and innovative approach to program design and management
* A fundamental belief that teamwork and collaboration with Manufacturing, Quality, Regulatory, Medical, Clinical and Commercial is critical
* Ability to manage multiple responsibilities with a high degree of self-motivation
* Excellent oral, written and interpersonal communication skills
* Ability to effectively influence people and gain alignment
* Possess an uncompromising commitment to quality and ultimately to the patients we serve
Up to 25% travel to suppliers and partners as required
Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law.