Research Associate 2 - Analytical Development
At Pacira Pharmaceuticals, controlling postsurgical pain is the key to improving patient outcomes. Our in-depth knowledge of the needs of the postsurgical pain market, coupled with our passion for delivering improved patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results. Pacira Pharmaceuticals currently has an opening for a Research Associate 2.
The purpose of this position is to provide data analysis and troubleshooting support for pharmaceutical processes, scale-up, and raw materials/APIs for sterile commercial product manufacture.
Analyze QC release data, in-process manufacturing data and stability data to aid in investigations and write product impact statements for quality events.
Perform hands on work to set-up and run experiments on lab and commercial scale manufacturing equipment.
Trouble-shoot problems that arise during all stages of development and in commercial manufacture of sterile injectable drugs.
Assist in performing laboratory investigations. Contribute to written investigation reports as required.
Assist with the maintenance and establishment of raw material and API specifications for commercial and clinical products.
Assist in executing project plans for periodic specification revisions which includes performing gap assessments, revising specifications, and preparing regulatory and technical documentation.
Coordinate with Pacira QC, ARD or CRO on any work or analysis related to specifications.
Support raw material and API qualification activities as needed.
Assist in communication with raw material suppliers
Assist in technical reviews of critical raw material suppliers.
Maintain a level of technical knowledge and understanding in the assigned areas of responsibility that are consistent with the current scientific requirements of the company.
Work cross functionally with R&D, Operations and Quality to provide scientific support for new and existing products.
The qualified individual will possess the following:
BS degree in relevant field of study (e.g. chemistry, pharmacy, biology, engineering, etc.) from an accredited college or university.
Preferably 2-5 years of pharmaceutical and/or R&D experience
Dissolution experience required
Good understanding of the chemical and physical principals upon which formulation, process development and analytical methodology is based.
Familiarity with cGMPs.
Familiarity with typical laboratory and processing equipment (e.g. HPLC, UV Spec, pH meter, centrifuge, etc.).
Ability to utilize scientific information resources within the assigned area of responsibility.
Good observation skill, problem solving, and troubleshooting skills (e.g. rational progression of investigation).
Good understanding of the scientific thinking in the design of experimental protocols.
Good documentation skills (e.g. notebook, reports) with attention to detail and legible handwriting.
Good organizational skills (e.g. daily tasks, documentation, archived information).
Good interpersonal skills (e.g. working with members of other teams to achieve shared goals).
Good verbal and written English communication skills (e.g. able to participate in scientific discussions and written interactions).
Proficient in the use of computers and widely used workplace applications (e.g. Microsoft Office, Outlook, graphing software, etc.).
Ability to be flexible in adapting work plan to current corporate goals.
Good time management skills (e.g. multi-tasking and task prioritization).
Equal Opportunity Employer/Veterans/Disabled