Scientist 1 - R&D

Research & Development San Diego, CA


Description

About Pacira

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.

Why work with us?

Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people.  At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together.

The purpose of this position is to provide management to pipeline product scale-up, development, and manufacture through pre-clinical stage.  In addition, this position is responsible to act as subject matter expert in technical transfer for pipeline product to clinical system for clinical stage of development. Other responsibilities may include additional support of commercial research projects as needed.

Essential Duties & Responsibilities:

  • Provide leadership, mentorship, and management of Process Development Projects.
  • Aid as product subject matter expert for product scale up from pre-clinical to clinical scale. Areas include process development, optimization, and formulation optimization where necessary.
  • Lead process development group in resolution of technical issues as well as process improvements.
  • Support regulatory submissions for pipeline products.
  • Lead and organize manufacture of toxicological material for preclinical PK studies required for Pacira’s pipeline product development.
  • Design and perform characterization of manufacturing processes to identify in-process controls and critical process parameters.
  • Develop, manage, and execute tactical and strategic plan to support current and future clinical operational needs.
  • Oversee the evaluation and implementation of emerging technologies for in-process characterization and proprietary technology production.
  • Critically evaluate experimental results.
  • Summarize findings for presentations, technical reports, and manuscripts.
  • Maintain high level of technical knowledge in areas of responsibility.
  • Provide training and technical assistance to less experienced lab personnel.
  • Comply with cGMPs where appropriate.
  • Maintain cooperative working relationships with other departments (e.g. QC, QA, Operations, regulatory and within R&D).
  • Maintain good documentation and exercise clear, concise communication skills.

Supervisory Responsibilities:

  • Supervise direct reports

Interaction:

  • The incumbent works closely with various departments (e.g. QC, QA, Operations, regulatory and within R&D) as well as with external contractors and consultants.

Education and Experience:

  • BS. in chemistry or relevant field of study from an accredited college or university + at least 8y progressively responsible development experience, including supervision of direct reports.
  • PhD in chemistry or relevant field of study from an accredited college or university with 1-3y industry experience and supervision of direct reports.

Knowledge, Skills, and Abilities:

  • Extensive knowledge of current Good Manufacturing Practices (cGMPs). Thorough knowledge of current regulatory requirements for product development and validation at each stage of product development.
  • Proficient in the use of and well versed in process development, in-process testing and the maintenance of process equipment. 
  • Strong organizational skills (e.g. daily tasks, documentation, archived information).
  • Strong interpersonal skills (e.g. working with members of other teams to achieve shared goals).
  • Proficient in the use of computers and widely used workplace applications (e.g. Microsoft Office, Outlook, graphing software, etc.).
  • Hands-on approach with a strategic and operational focus; capable decision maker in the execution of responsibilities with a high degree of flexibility to adapt to company and industry changes.
  • Collaborative leader able to operate effectively and with a strong sense of urgency in a fast-paced environment.
  • Organized problem solving and troubleshooting skills (e.g. rational progression of investigation).
  • Thorough understanding of the chemical and physical principals upon which formulation, process development and analytical methodology is based.
  • Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.
  • Excellent documentation skills (e.g. notebook, reports).
  • Experience in designing and overseeing DOEs, range finding studies, cleaning studies and new process development.

EEO Statement

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.

At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.