Manages the QC Flow Cytometry operations and staff. Demonstrates mastery of flow cytometry theory and practice on multiple platforms. Experienced Manager that demonstrates leadership in a fast-paced industry setting and operates with minimal oversight and has a clear understanding of business and GMP regulatory demands.
Exhibits rigorous scientific and supervisory skills, a strong practical knowledge of biopharmaceutical manufacturing and testing, and excellent understanding of current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) compliance requirements. Efficiently manages staff and other resources to address scientific, business and regulatory needs in an effective and timely manner. Interacts with internal and external customers and auditors as needed to provide support and address any comments/issues.
ResponsibilitiesSupervises, plans, & reviews operations for QC flow cytometry department, including training.Recommends personnel actions and manages employee relations including performance reviews.Demonstrates leadership and is supportive of company goals and objectives.Responsible for leading the on-time completion of client sample testing in a cGMP compliant manner within the departmentAs assigned by management, acts as a technical reviewer for select assay and assumes all associated responsibilities.Conducts critical review of test results and reports data to appropriate employees.Interacts with all departments to assure that appropriate testing information is effectively communicated.Interacts will clients to address scientific and related issues.Ensures quality control testing is scheduled and performedAccomplishes staff results by communicating updated organizational information, job expectations & supporting their workPlans, monitors, and appraises direct reports including performance competencies, goals & job resultsCoaches, counsels, and conducts disciplinary actionsDevelops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standardsInteracts with clients to discuss project planning and testing issuesProvides strong in-house guidance on science and technologyInitiates development of new technologies or assays as appropriateInteracts with internal staff to identify assays requiring further improvement or development and oversees improvement of these assaysTravels with other WuXi AppTec staff to visit clients as appropriatePresents technical seminars at external professional meetingsResponsible for appropriately conducting assays in accordance with cGMPsAssures that laboratory personnel are following all company SOPs and safety rulesPrepares and revises technical documents (Laboratory Protocols, SOPs, etc.)Assures that batch records and other paperwork are completed according to cGMPs and company SOPsAbility to work in a team environment and independently as requiredMaybe required to work Holidays and weekendsContributes to the overall operations and to the achievement of departmental goalsPerform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.Thorough understanding of Good Manufacturing PracticesOther duties as assignedMay be required to assist in other departments Qualifications Bachelor’s degree with major in Biological Sciences, Medical Technology or other science-related major and 15+ years of relevant scientific experience and 5+ years of managerial experience.Master’s degree with major in Biological Sciences, Medical Technology or other science-related major and 13+ years of relevant scientific experience and 5+ years of managerial experience.Doctorate degree with major in Biological Sciences, Medical Technology or other science-related major and 10+ years of relevant scientific experience and 5+ years of managerial experience.
Knowledge / Skills / Abilities:
Must have 15+ years of flow cytometry experience related to assay design and execution of 8+ color assays. Experience is assay validation is highly desiredKnowledge of cGMP guidelines is desirableAbility to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly requiredAbility to evaluate technical data and write technical documentsAbility to use judgment as dictated by complexity of situationAbility to work under limited supervision and to handle problems of a difficult natureAbility to accomplish the described duties through the use of appropriate laboratory equipment (i.e. biohazard hood, centrifuge, incubator, and autoclave) and computer equipment and software. (i.e. Microsoft Word, Outlook)Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculationsAbility to record data accurately and legiblyAbility to understand and follow verbal or demonstrated instructionsAbility to express or exchange ideas by means of the spoken wordAbility to work effectively as part of a team and to exhibit effective interpersonal skillsAbility to receive and comprehend and to effectively communicate detailed information through verbal and written communicationProficient in Oral & Written communication skillsNeed to be able to read, write and understand EnglishProficient in Microsoft (Excel, Word, Outlook)New hires must be fully vaccinated against COVID-19 and provide proof of vaccination or receive an approved medical or religious exemption from Human Resources. This offer is contingent upon WuXi ATU verifying your vaccination status or approving an exemption request prior to your start date. If you wish to be considered for a medical or religious exemption, request an exemption by notifying WuXi as soon as possible, but no later than one week before your start date.
Our Values:
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.
WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
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