Allergan Sr. Scientist, Biologics Development in Irvine, California
Sr. Scientist, Biologics Development
Irvine, California, United States at https://agn.referrals.selectminds.com/jobs/7701/other-jobs-matching/location-only
Jan 11, 2019Post 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 Sr. Scientist is responsible for development, qualification, transfer, and validation of analytical methods for analysis of proteins, peptides, excipients, and impurities to support drug substance process development, drug product formulation development, stability studies, and characterization work. Provides scientific leadership as an expert in various analytical techniques such as chromatography and capillary electrophoresis and associated detection methods such as UV, fluorescence, RI, light scattering, charged aerosol detector, and mass spectrometry. Responsible for the establishment of analytical development strategies for CMC teams; must ensure the work is performed in a timely manner and consistent with regulatory expectations. Contribute to writing and reviewing protocols and reports for internal use or CMO/CROs as well as for submission to regulatory agencies. Represents Allergan at in-house team meetings and in external scientific and regulatory meetings. Additionally, the Sr. Scientist is responsible for maintenance of analytical instruments such as HPLC, CE and LC-MS.
Position requires individual to work with Select Agents. Access to, and use of, select agents is covered by Federal policies. Violation of, or failing to support the intent of, Select Agent policies, regulations, or laws can result in substantial fines and/or imprisonment, as well as civil monetary penalties and are considered grounds for dismissal.
Main Areas ofResponsibilities
Designs and executes/supervisesthe development, qualification, transfer, and validation of analytical methodsusing multiple analytical techniques such as HPLC and CE.Creates written procedures and protocols. Transfers,qualifies or validates methods as needed. Mentors staff within a matrixenvironment when needed. Maintains reagent supplies, notebooks, summarizesresults in written reports and communicates observations to ensure that the enduser receives quality methods in a timely manner. Complies with QualityPrincipals related to data generation and reporting.
Applies routine andspecialized analytical techniques to characterize and quantify biopharmaceuticals.Leads study design, execution, and data summary/report of characterization and investigationstudies per project needs.
Actively participates oncross-functional teams within Biologics Development and provides support to externaldepartments as time permits. Shall be included on CMC development teams as theSME in Analytical. Openly shares scientific expertise and collaboratively helpsthe team to formulate rational solutions to problems. Shares expertise,instruments and resources within the limitation of established priorities.
Develops protocols and SOPs,trains staff and maintains the laboratory consistent with departmental andAllergan requirements. Understands, documents and adjusts Quality Systems tomatch the project stage (e.g. pre-development or development).
Maintains a good and currentknowledge of the scientific and technical literature pertinent to the projectand necessary for development of state of the art production and analyticalmethods and acquisition of reasonable and necessary equipment.
Makes high quality scientificpresentations at internal management, regional and national meetings to helpadvance Allergan’s image as the thought and product leader in the neuromodulatorfield. Presents and defends product, bioassay and process data to regulatoryagencies.
The following listed requirements need to be met at a minimum level to be considered for the job:
Strong analytical and instrument skills and athorough understanding and working knowledge of analytical method development, qualification,transfer, and validation with emphasis on chromatographic and capillaryelectrophoresis-based methods.
Skilled in the application of scientific designprinciples and analytical techniques to the problems associated withbiologicals and/or biopharmaceutical development.
Extensive experience with the application ofHPLC and CE for the separation, qualification, and characterization ofbiological molecules including peptide, protein and protein complex in variousmatrices such as drug products formulated in protein, polymer, surfactant, sustainedrelease drug products.
Extensiveexperience with a wide variety of chromatographic methods for proteincharacterization (reverse phase, ion exchange, size exclusion, hydrophilicinteraction, and affinity chromatography) as well as related techniques such ascapillary electrophoresis. Excellent instrument skills including the use ofstandard and capillary HPLC systems and their associated detectors. Experiencewith the operation of various instruments such as Waters HPLC, Agilent HPLC,Beckman CE, and Protein Simple systems and familiar with the programs (e.g.Empower) for the instrument control and data analysis.
Experience with performing characterizationwork for regulatory submissions and/or the development of methods for usewithin a QC environment is required. Must be able to lead cross-functionalteams for characterization and investigational studies including designing thestudy, coordinating the execution, summarizing the results, and reporting inappropriate documentation per project needs.
A working knowledge of the requirements ofworking in a GLP or cGMP environment is helpful.
- (Ph.D) and 4 to 5 years of relevantindustry experience or a MS degree and 7 or more years ofapplied experience may also qualify.
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.