Allergan Scientific Associate III, Small Molecule Product Development in Irvine, California
Scientific Associate III, Small Molecule Product Development
Irvine, California, United States at https://agn.referrals.selectminds.com/jobs/5921/other-jobs-matching/location-only
Jul 09, 2018Post Date
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
The Scientific Associate III, Analytical Development – plans and performs analytical laboratory experiments, validates and transfers methods to support all stages of drug development for assigned projects.
Main Areas of Responsibilities
Independently perform a variety of project-oriented analytical work assignments (e.g., perform analytical experiments, organize data, and analyze/record/report results and conclusions of experiments) to support the development of drug substances and products.
Provide analytical support for investigative studies and troubleshooting analytical issues.
Interact with contract laboratories to troubleshoot analytical issues and/or address lab incidents and investigations.
Design and conduct stability studies for drug substance and drug product to satisfy global regulatory requirements.
Participate and contribute at group and project meetings as required (e.g., prepare and present results and conclusions to project sub-teams).
Authors critical technical documentation in the form of technical memos, protocols and reports and appropriate portions of CMC sections of INDs, NDAs, MAAs for use in submissions to world-wide government agencies for final market approval.
Must have a thorough working knowledge of a wide range of analytical instrumentation (i.e. HPLC, UPLC, GC, Dissolution, LC-MS, GC-MS, etc.).
Strong knowledge of analytical techniques, data processing software and strong computer skills.
Strong ability to plan and self-manage assigned work to meet timelines.
Demonstrated ability to design and plan experiments, interpret data and present conclusions. Ability to troubleshoot experimental problems and propose solutions.
Ability to troubleshoot experimental problems and propose solutions.
Proven ability to write scientific reports including data analysis and conclusions of work to support world-wide regulatory submissions.
Experience working in a cGMP analytical laboratory is required.
Working knowledge in drug development process, ICH and international stability requirements.
Excellent technical written and oral communications as well as proven time management.
Knowledgeable using statistical programs for analytical data evaluation.
Experience in developing new analytical methods. Independently qualify/validate analytical methods following the guideline.
Must possess good interpersonal skills, the ability to work in a dynamic team environment and must multi-task to meet project timelines.
Master degree with 3-5 years or a B.S degree with 6-8 years in analysis of pharmaceutical products and pharmaceutical method development and validation. Minimum 4 years of experience in the analysis of data and writing of technical protocols, reports, and submission ready documents.
Degree should be in Pharmaceutics, Analytical Chemistry, Pharmaceutical Chemistry or Organic Chemistry.
Equal Employment Opportunity Employer
Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.