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Job Details

Protein Characterization Scientist HPLC

Company name
Apex Systems, Inc.

San Diego, CA
2 hit(s)  


\u003Cdiv\u003E\u003Cdiv\u003E\u003Cdiv\u003E\u003Cdiv\u003E\u003Cp\u003EOur client, a leading developer of protein purification systems and products, is seeking an Analytical Biochemist to join their expanding team. \u003C/p\u003E\u003C/div\u003E\u003C/div\u003E\u003C/div\u003E\u003C/div\u003E\u003Cp\u003E\u003Cb\u003EESSENTIAL DUTIES AND PRIMARY RESPONSIBILITIES\u003C/b\u003E\u003C/p\u003E\u003Cp\u003E\u003Cb\u003ETechnical Scope\u003C/b\u003E\u003C/p\u003E\u003Cul\u003E\u003Cli\u003EServe as Analytical Biochemistry (AB) subject matter expert in the development/ commercialization of recombinant proteins that requires knowledge and application of analytical technologies involving primarily HPLC separations, SDS-PAGE, Western blots, UV-Vis spectrophotometry, and other analytical protein characterization methods\u003C/li\u003E\u003Cli\u003EResponsible for developing method robustness and other analytical parameters prior to analytical method Tech Transfer to QC CMO for validation\u003C/li\u003E\u003Cli\u003EFacilitate and lead method transfers between our CMO and/or partners\u003C/li\u003E\u003Cli\u003EPartner with a diverse team of Process Development/ Characterization Scientists in USP, DSP and Analytical Biochemistry that support the advancement of a broad portfolio of products\u003C/li\u003E\u003Cli\u003EProvides expertise, guidance, and feedback on protein analytical results so as to direct effective purification development and product/process control strategies\u003C/li\u003E\u003Cli\u003EKeeps current in analytical method development including literature and technology development and regulatory driven activities\u003C/li\u003E\u003Cli\u003EAuthor/Review detailed analytical reports and provides direct input/data/statistical analysis to support data package for regulatory submission(s)\u003C/li\u003E\u003Cli\u003EInterface with contract manufacturing or research organizations (CMOs/CROs) in the execution of analytical method transfer, testing, and release and stability studies\u003C/li\u003E\u003Cli\u003EAssembles and delivers CMC supporting regulatory documentation required to rationalize process analytical, characterization, and release specifications\u003C/li\u003E\u003Cli\u003EWith minimal supervision, generates and delivers concise/clear technical presentations to senior management\u003C/li\u003E\u003Cli\u003EOther duties as assigned or required\u003C/li\u003E\u003C/ul\u003E\u003Cp\u003E\u003Cb\u003EJOB SKILLS, ABILITIES AND QUALIFICATIONS\u003C/b\u003E\u003C/p\u003E\u003Cul\u003E\u003Cli\u003EA minimum of a Bachelor\u0026#39;s degree in Analytical Chemistry/Biochemistry/Biochemical Engineering/Biology or related field with biosimilar and/or biologics experience required
\t\u003Cul\u003E\u003Cli\u003EBS 5 years of relevant experience w/a minimum of 5 years of industry experience\u003C/li\u003E\u003Cli\u003Eor MS 3 years of relevant experience w/a minimum of 3 years of industry experience\u003C/li\u003E\u003Cli\u003Eor PhD 6 to 12 months of relevant industry experience\u003C/li\u003E\u003C/ul\u003E\u003C/li\u003E\u003Cli\u003EAbility to travel up to 10% (US and Internationally)\u003C/li\u003E\u003Cli\u003EFluent in practical application of PC\u0026rsquo;s, Microsoft project, Word, Excel, Power point and experience to include data analyses, statistical analysis (JMP), method transfers and comparability studies\u003C/li\u003E\u003Cli\u003EExperience in developing and qualifying analytical methods, primarily HPLC separations\u003C/li\u003E\u003Cli\u003EScientific understanding of current analytical technologies, as well as the ability to explore and develop novel approaches to further advance innovative analytical methodologies\u003C/li\u003E\u003Cli\u003EProven working knowledge and understanding of GxP (GLP, cGMP, GCP and ISO9000) environments and regulations required\u003C/li\u003E\u003Cli\u003EAbility to work flexible work schedules\u003C/li\u003E\u003Cli\u003EAnalyzes reports, metrics and results as required; provides SME and strategic guidance based on findings\u003C/li\u003E\u003Cli\u003EExcellent verbal and written communication skills, an innovative approach to problem-solving, an integrated view of business/scientific issues, and a strong work ethic\u003C/li\u003E\u003Cli\u003EPossesses and demonstrates exceptional research and resource utilization skills as well as practical problem solving capabilities\u003C/li\u003E\u003Cli\u003EProven ability to work in a lean organization and creatively tackle problems using colleague networks and publicly available solutions; work independently and successfully in a matrix environment; and prioritize and manage multiple tasks simultaneously\u003C/li\u003E\u003Cli\u003EOther duties as assigned or required\u003C/li\u003E\u003C/ul\u003E\u003Cp\u003E\u003Cb\u003ESupplemental Experience (Strong Plus)\u003C/b\u003E\u003C/p\u003E\u003Cul\u003E\u003Cli\u003EExperience working in a biosimilars drug-development organization highly preferred\u003C/li\u003E\u003Cli\u003EExperience with the full product lifecycle of a biopharmaceutical product (i.e. Phases 1 \u0026ndash; 4) highly preferred\u003C/li\u003E\u003Cli\u003EWorking knowledge of U.S. Government-funded programs is preferred\u003C/li\u003E\u003C/ul\u003E\u003Cp\u003EEEO Employer\u003C/p\u003E\u003Cp\u003EApex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at \u003Ca href=\\\\u003C/a\u003E or 844-463-6178.\u003C/p\u003E\u003Cbr\u003E\u003Cdiv\u003EVEVRAA Federal Contractor\u003C/div\u003E\u003Cdiv\u003EWe request Priority Protected Veteran \u0026 Disabled Referrals for all of our locations within the state.\u003C/div\u003E\u003Cdiv\u003EWe are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available \u003Ca href=\\ target=\_blank\\u003Ehere.\u003C/a\u003E\u003C/div\u003E,datePosted:2018-05-16,employmentType:FULL_TIME,industry:Information Technology,hiringOrganization:{@type:Organization,name:Apex Systems, Inc.},identifier:{@type:PropertyValue,name:Apex Systems, Inc.,value:849508},jobLocation:{@type:Place,address:{@type:PostalAddress,addressCountry:US,streetAddress:,addressLocality:San Diego,addressRegion:CA,postalCode:92101}}}

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