{"id":3235,"date":"2023-01-19T03:05:49","date_gmt":"2023-01-18T21:35:49","guid":{"rendered":"https:\/\/pharmaceuticalcarrier.com\/?post_type=job_listing&#038;p=3235"},"modified":"2023-07-19T03:27:43","modified_gmt":"2023-07-18T21:57:43","slug":"great-opportunity-as-a-quality-manager-in-re-vana-therapeutics-u-k","status":"publish","type":"job_listing","link":"https:\/\/pharmaceuticalcarrier.com\/index.php\/job\/great-opportunity-as-a-quality-manager-in-re-vana-therapeutics-u-k\/","title":{"rendered":"Great Opportunity as a quality manager in Re-Vana Therapeutics U.K."},"content":{"rendered":"<p><strong>Quality Manager &#8211; Re-Vana Therapeutics<\/strong><\/p><div class=\"pharm-content\" id=\"pharm-274327041\"><script async src=\"\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-8402705006112223\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display:block;\" data-ad-client=\"ca-pub-8402705006112223\" \ndata-ad-slot=\"7652789694\" \ndata-ad-format=\"auto\"><\/ins>\n<script> \n(adsbygoogle = window.adsbygoogle || []).push({}); \n<\/script>\n<\/div>\n<p><strong>Department: R&amp;D &#8211; <\/strong>Quality<br \/>\nLocation Belfast, Northern Ireland<\/p>\n<p><strong>Introduction<\/strong><br \/>\nRe-Vana Therapeutics, founded in 2016 and incorporated in both the U.K. and U.S. is a spin-out<br \/>\nfrom Queen\u2019s University Belfast (QUB) Northern Ireland. We are developing innovative and<br \/>\nproprietary biodegradable sustained-release technologies for the delivery of biologics and small<br \/>\nmolecules drugs, with a focus on ophthalmic indications.<br \/>\nOur value proposition is the ability to develop \u201ccustomized\u201d sustained-release implants capable of<br \/>\ndelivering both biologics and small molecules for as long as 6 months or more, thus reducing the<br \/>\nfrequency of ocular injections and reducing or eliminating the need for topical eye drops. The<br \/>\nsustained delivery of biologic drugs is recognized as one of the major unmet needs within<br \/>\nophthalmology. Currently, ophthalmic biologic drugs represent a $14B market worldwide with growth<br \/>\nprojections reaching more than $22B by 2024.<br \/>\nOur dual strategy includes the internal development of sustained-release therapeutics alongside the<br \/>\ndevelopment of external strategic collaborations with major pharmaceutical partners. To date ReVana has achieved significant progress and global awareness, raising seed money in 2017, a preSeries A in 2020 and a Series A in 2022 that included leading U.S. Ophthalmic and U.K. Venture<br \/>\nCapital Investors. We have been awarded two significant Innovate U.K. government grants for the<br \/>\ndevelopment of sustained-release ocular biologics. In 2022, we were awarded the prestigious<br \/>\nOphthalmic Innovation Summit Retina Award for \u201cDrug Delivery Innovation\u201d and the Belfast<br \/>\nChamber \u201cBusiness Innovation\u201d company of the year. In addition, Re-Vana has established a<br \/>\ncompelling Scientific Advisory Board (SAB) that includes global ophthalmic opinion leaders.<br \/>\nWe are seeking to further strengthen the team by hiring a full-time Quality Manager to develop and<br \/>\nmanage a Quality Control system within the company.<\/p>\n<p>The successful candidate will be a key member of the Belfast based team. Reporting to the COO,<br \/>\nhe\/she will work extensively with the CEO and CTO and the internal scientific team.<\/p>\n<p>This is an outstanding opportunity to help build and contribute significantly to the strategic success of<br \/>\na well-capitalized, highly innovative startup company within a multibillion dollar market potential.<\/p>\n<p><strong>Brief Description of Role:<\/strong><br \/>\nRe-Vana is looking for an individual to assume responsibility for the initial management of the Quality<br \/>\nControl\/Assurance and Document Controls functions for Re-Vana, as the organization grows these<br \/>\nwill become separate well-defined roles. The role will include oversight, identification, development<br \/>\nand maintenance of R&amp;D quality processes including analytical data, documentation, development<br \/>\nand maintenance of internal and in process materials, Finished Goods lot release and stability testing<br \/>\nfor in vivo testing, internal and external technology development, evaluation and investigation of<br \/>\nOOS. Act as Quality Control expert providing support for product development and<br \/>\ncommercialization of drug\/device combination products. Support analytical method<br \/>\ndevelopment\/validation\/transfer.<\/p>\n<p><strong>Responsibilities:<\/strong><br \/>\n\u2022 Develop, implement and own a Quality System including all procedures and processes<br \/>\n\u2022 Distribute documentation throughout the organization, on time, to the people who need it<br \/>\n\u2022 Oversee testing for raw materials, intermediate materials and final polymer based photo<br \/>\ncrosslinked drug delivery products<br \/>\n\u2022 Responsible for the identification, selection, qualification, and oversight of analytical laboratories<br \/>\nconducting Quality Control testing, including contract negotiations, future on-site audits and<br \/>\nsupplier development activities<br \/>\n\u2022 Act as the primary company liaison for Quality Control testing; including communicating testing<br \/>\npriorities, review and approval of OOS investigations, and test method maintenance<br \/>\n\u2022 Oversee and own the process for review and approval of analytical data for future GMP testing<br \/>\nof raw materials, in-process materials and finished drug product<br \/>\n\u2022 Act as Quality Control during inspections and conferences<br \/>\nwith FDA, Notified Body, Competent Authority and other regulatory agencies<br \/>\n\u2022 Proactively identify quality related vulnerabilities and champion improvements in<br \/>\ncompany wide activities<br \/>\n\u2022 Facilitate effective communication and collaboration between the R&amp;D team and senior<br \/>\nmanagement<br \/>\n\u2022 Maintain current knowledge of federal, state and international regulations and guidance<br \/>\ndocuments, as applicable (QSR, cGMP, ISO, ICH, etc.)<br \/>\n\u2022 Support NCMR, CAPA, Complaint and Internal Audit investigations as needed<br \/>\n\u2022 Thoroughly document all issues related to quality control, QSR, cGMP, ICH and ISO compliance<br \/>\n\u2022 Support company goals and objectives, policies and procedures<\/p>\n<p><strong>Requirements:<\/strong><br \/>\n\u2022 B.Sc. in Life Sciences, Chemistry, Chemical Engineering<br \/>\n\u2022 Minimum 5 years related experience in the pharmaceutical industry supporting GMP testing<br \/>\nactivities &#8211; start up experience a bonus<br \/>\n\u2022 A willingness to work hard, with a driven outlook and with a strong desire to succeed, as a scientist,<br \/>\nas a team, and as a company<br \/>\n\u2022 An inventive aptitude balanced with discipline and concern for detail<br \/>\n\u2022 Motivated to initiate a new Quality Control system in an academic based, pre-clinical start-up<br \/>\ncompany<br \/>\n\u2022 Experience working on drug\/device combination products and \/ or pharmaceutical development<br \/>\nand manufacturing, from concept through commercialization<br \/>\n\u2022 Strong knowledge of domestic and international CGMP, CMC and Analytical regulatory<br \/>\nrequirements<br \/>\n\u2022 Ability to translate regulations and guidance documents into company procedures and provide<br \/>\ntraining to cross-functional teams<br \/>\n\u2022 Excellent communication and time management skills required<br \/>\n\u2022 Strong team player with ability to work with diverse cross functional teams<br \/>\n\u2022 Ability to work independently and be able to manage tight timelines and changing priorities<br \/>\n\u2022 Working knowledge of statistical techniques (e.g. sample size determination, tolerance intervals,<br \/>\ncapability analysis, Regression, ANOVA, DOE) using statistical software packages (e.g. Excel,<br \/>\nMinitab, JMP)<\/p>\n<p><strong>Additional<\/strong><br \/>\nRemuneration to be based on a fixed salary, bonus and stock options relevant to a startup<br \/>\norganization<\/p>\n<p><strong>Contact<\/strong><br \/>\nPlease send an updated CV with supporting letter to<br \/>\nMichael O\u2019Rourke CEO<br \/>\nmor@revanatx.com<\/p>\n<blockquote class=\"wp-embedded-content\" data-secret=\"uL7yXXGmDm\"><p><a href=\"https:\/\/www.revanatx.com\/\">Home<\/a><\/p><\/blockquote>\n<p><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; clip: rect(1px, 1px, 1px, 1px);\" title=\"&#8220;Home&#8221; &#8212; Re-Vana: Making Great Drugs Better\" src=\"https:\/\/www.revanatx.com\/embed\/#?secret=EacfQrA2bB#?secret=uL7yXXGmDm\" data-secret=\"uL7yXXGmDm\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe><br \/>\n+1 813 323 1438 (Tampa Florida)<\/p>\n","protected":false},"author":1,"featured_media":3232,"template":"","meta":{"_uag_custom_page_level_css":"","_promoted":"","_job_location":"Belfast","_application":"mor@revanatx.com","_company_name":"Re-Vana Therapeutics","_company_website":"https:\/\/www.revanatx.com\/","_company_tagline":"","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job-categories":[],"job-types":[17],"class_list":{"0":"post-3235","1":"job_listing","2":"type-job_listing","3":"status-publish","4":"has-post-thumbnail","5":"hentry","7":"job-type-full-time"},"uagb_featured_image_src":{"full":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2023\/01\/Revana-logo.png",1537,957,false],"thumbnail":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2023\/01\/Revana-logo-150x150.png",150,150,true],"medium":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2023\/01\/Revana-logo-300x187.png",300,187,true],"medium_large":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2023\/01\/Revana-logo-768x478.png",640,398,true],"large":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2023\/01\/Revana-logo-1024x638.png",640,399,true],"1536x1536":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2023\/01\/Revana-logo.png",1536,956,false],"2048x2048":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2023\/01\/Revana-logo.png",1537,957,false],"authorship-box-avatar":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2023\/01\/Revana-logo-150x150.png",150,150,true],"authorship-box-related":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2023\/01\/Revana-logo-70x70.png",70,70,true],"sow-carousel-default":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2023\/01\/Revana-logo-272x182.png",272,182,true]},"uagb_author_info":{"display_name":"Pharmacareer","author_link":"https:\/\/pharmaceuticalcarrier.com\/index.php\/author\/grandirpharmagmail-com\/"},"uagb_comment_info":0,"uagb_excerpt":"Quality Manager &#8211; Re-Vana Therapeutics Department: R&amp;D &#8211; Quality Location Belfast, Northern Ireland Introduction Re-Vana Therapeutics, founded in 2016 and incorporated in both the U.K. and U.S. is a spin-out from Queen\u2019s University Belfast (QUB) Northern Ireland. We are developing Read More","_links":{"self":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/job-listings\/3235","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/job-listings"}],"about":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/types\/job_listing"}],"author":[{"embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/media\/3232"}],"wp:attachment":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/media?parent=3235"}],"wp:term":[{"taxonomy":"job_listing_category","embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/job-categories?post=3235"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/job-types?post=3235"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}