BeiGene

This is a leadership position within MST that requires advanced technical expertise in protein purification skills, included but not limited to chromatography, filtration (tangential flow, depth, viral and dead end) in addition to general knowledge for mammalian cell culture processes and/or, formulation, protein product quality attributes, and advanced data analysis skills.. Of equal importance, is the ability to develop rapport internal and external to MST. This position plays a leading role of purification group in technology transfer, troubleshooting processes, building a detailed understanding of them, and driving process robustness by setting clear objectives and empowering their team.. Utilize fundamental engineering principles relevant to bioprocess unit operations for scale-up and technology transfer.. Experience with downstream process design, optimization, and tech transfer to clinical/commercial manufacturing facilities.. Computer Skills: MS Office and statistical software including but not limited to SAS JMP, Minitab, etc.

purification

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General Description: This position reports directly to Manufacturing Science & Technology (MST) Team Leader and this position plays a critical role leading role of purification group. This is a leadership position within MST that requires advanced technical expertise in protein purification skills, included but not limited to chromatography, filtration (tangential flow, depth, viral and dead end) in addition to general knowledge for mammalian cell culture processes and/or, formulation, protein product quality attributes, and advanced data analysis skills. Of equal importance, is the ability to develop rapport internal and external to MST. This position plays a leading role of purification group in technology transfer, troubleshooting processes, building a detailed understanding of them, and driving process robustness by setting clear objectives and empowering their team. This position involves close collaboration within MST, Process Development, Manufacturing, Quality Control, Quality Assurance, and Regulatory groups. Essential Functions of the job: Leading, mentoring and developing staff is a critical part of the responsibility, with an aim to empower team members to a level commensurate with their skills and experience.Provide scientific leadership for the site and company with the aim to ensure steady product supply, process robustness and a focus on cost of goods reduction.Scale-up through technology/process transfer to clinical and commercial manufacturing.Ensure the accurate and complete documentation of any scientific experimental plan, data, or report.Effective communication with team members and stakeholders is a must.Utilize fundamental engineering principles relevant to bioprocess unit operations for scale-up and technology transfer.Participate in and support on-site supervision and management of contract manufacturers as required by BeiGene.Any other assignment as is determined by supervisor.Technical/Skills Required:Expertise in Green-Field Projects for Mab Facilities and Process Design / Development.Expertise in equipment identification/procurement as well as DQ, IOQ and Validation activities.Expertise with chromatography systems (AKTA), tangential flow filtration, analytical equipment.Ability and aptitude for analyzing data, detecting inconsistencies, determining relative importance, and utilizing data and risk analysis tools.Experience with downstream process design, optimization, and tech transfer to clinical/commercial manufacturing facilities.Expertise with study design such as DOE and authoring of study protocols / reports.Good understanding of GMP requirements. Proven planning and data analysis skills, use of statistical software to analyze dataProject management skills related to internal and external teams Knowledge of regulations and guidelines of FDA, EMA, ICH, PDA.Working Experience:Minimum of 10 years of experience in the Life Science/Biotech industryExperienced in raw material characterization, biological manufacturing purification manufacturing development and production operations at various scalesFamiliarity with EMA and FDA regulatory requirements for process development submissions Broad knowledge of drug development, CMC, MST, preclinical and clinical requirements Experience in effectively managing scientific groups and projects Demonstrated effective communication, oral and written, in a multi-disciplinary, project-driven work environment Demonstrated skill in leading project teams tasked with resolving complex production related issues Good written and communication skills Familiar with software such as Microsoft Office including Microsoft Project, Visio, etc.Physical Requirements:Must be able to stand for long periods, up to 8 to 10 hours/dayMust be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequentlyMust be able to work scheduled 40 hours with the ability to work overtime as neededMust be comfortable in working in varying temperaturesFrequent lifting, pushing, pulling, and carrying. Ability to lift up to 40 lbsRegular reaching, bending, stooping, and twistingRepetitive motion and substantial movement of the wrists, hands, and/or fingersEnvironment requires dedicated gowns, depending on areaWork with hazardous materials and chemicalsWilling to work any shiftSupervisory Responsibilities: Leading, mentoring and developing staff is a critical aspect of the role.Computer Skills: MS Office and statistical software including but not limited to SAS JMP, Minitab, etc.Other Qualifications: N/ATravel: Some travel may occur as a result of duties assigned to the roleBeiGene Global CompetenciesWhen we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with ClaritySalary Range: $157,100.00 - $217,100.00 annuallyBeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

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