Senior Scientist - Biosimilars ARD

Job TypeFull-timeDescriptionSummaryA Sr. Scientist I will be a key technical resource responsible for independently developing methods, generating reliable and interpreting data, using analytical instrument that include HPLC, UPLC, GC, UV/Vis, dissolution apparatus and particle analyzer. You will be expected to develop a close working relationship with technical personnel at all levels within the organization to provide technical support needed in meeting R&D milestones and goals.Conduct instrumenttroubleshooting.or designing experiments, writing method validation protocols, conducting method validation, and processing and interpreting the analytical data.Essential Duties & ResponsibilitiesDevelop and validation analytical method for drug substances, drug products, and excipientsConduct routine and advanced analytical tests in accordance with SOPs and regulatory guidance.Write protocols, reports, methods, standard operation procedure, and submission documents.Provide analytical support for formulation and process development.Perform independent scheduling and coordination of activitiesComplies with all companypolicies and standardsAnalyze analytical data, identify trends and provide recommendation.Review laboratory notebooks, raw data and technical documentation (e.g. test method, validation protocol, or validation report) in support of regulatory filingsTrain and provide technical guidance to junior scientists. Conduct laboratory investigation and prepare laboratory investigation report.Proactively provide Lab management with suggestions on how to improve the methods, lab practice or lab system.Evaluate and improve existing test methodsProactively provide Lab management with suggestions on how to improve the methods, lab practice orlab system.ection.Review and evaluate drug substance supplier’s technical documents and provide recommendation in APIvendor selection.Performs other functions asrequired or assignedRequirementsPREREQUISITES:EducationMinimum B.S. degree in Analytical Chemistry, Biophysical/biochemical sciences, pharmaceutical sciences with 8 years industry experienceOr Master’s Degree in Biochemistry, Biotechnology, Biology with 5+ years’ experience in protein mass spectrometryOr Ph.D. in Biochemistry, Biotechnology, Biology with 3+ years of experience in protein mass spectrometryExperienceA strong theoretical understanding and experience in protein chemistry and biochemistry.In-depth hands-on experience with operation of HPLC, GC, dissolution, plate-readers and UV techniques is required.An in-depth understanding of USP requirements, ICH guidelines and USP/EP pharmacopeia requirementsExcellent communication and technical writing skillsExperience in method development, as well as method qualification/verification/validation in a GLP/GMP environmentStrong experience in analytical method development and validationDemonstrated skills as a team-player and team-management.Ability to plan, schedule and work independently in a fast pace environment. Self-motivation, adaptability, and a positive attitude.Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.Ability to work under pressure and meet deadlinesSpecialized Knowledge And SkillsAbility to multitask technical responsibilities in a fast-paced, dynamic environment is requiredProficiency with the following software is required: Microsoft Word, Excel, PowerPoint, and Outlook.Experience with Mass Spectrophotometer is required.Experience with Empower HPLC software programs is required.