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 to the Director of Manufacturing Sciences & Technology (Purification). MST Purification is focused of technology transfer activities, including scale-up and scale-down of processes from other internal or external groups. The activities consist of laboratory-scale work and support of manufacturing scale operations.  An understanding of chromatography separations, solution make-up, depth, normal, virus, and tangential flow filtration is important in this role. The position will be responsible for design and execution of laboratory experiments, data analysis and authoring of various protocols and reports. Also, the position will support technology transfers for large-scale manufacturing operations, process improvements, troubleshooting, compliance related activities, and provide technical support to manufacturing.

The position will be involved with tech transfer activities through the lifecycle of a project, including gap and risk assessments, generating technical transfer plans, process descriptions and control strategies, and related protocols and reports.

Working in MST provides a unique growth opportunity for professional exposure to many facets of process development and drug substance manufacturing.  This position involves close collaboration with Manufacturing, Supply Chain, Procurement, Quality Control, Quality Assurance, Regulatory, and Process Development groups.  In addition, as the BeiGene Hopewell progresses through initial start-up, process qualification, to becoming fully operational, it provides unique opportunities and challenges to anyone who is looking for career advancement.

Essential Job Functions:

Participate in cross-functional projects teams that provide tech support to manufacturing and process development, and able to present data and study findings in coherent manner.Ensure a safe working environment.Responsible for execution of laboratory experiments and maintaining support laboratory activities.Authoring of study protocols and reports, and other documentation supporting deviations and regulatory activities.Perform tech transfer activities, including facility gap and risk assessments.Provide technical support as SME for implementation of purification processes.Author technical transfer plans, process descriptions, control strategies, and campaign summary reports.Perform Continued Process Verification (CPV) and process monitoring during campaigns.Effective communication with team members and stakeholders.Serve as Person-In-Plant (PIP) during critical steps of the manufacturing process.Perform manufacturing data analysis.Participate in and support on-site supervision and management of contract employees or third parties.Any other assignment as is determined by the manager.

Qualifications:

Minimum of 2+ years of experience in the Life Science/Biotechnology after bachelor’s degree, 0+ years after master’s degree).Demonstrated experience working in purification laboratory or cGMP manufacturing.Knowledge of drug preclinical, clinical, and commercial requirements.Familiarity with FDA regulatory requirements for submissions. Effective communication, oral and written, in a multi-disciplinary, project-driven work environment.  Computer-savvy.Keen interest in being part of bringing life-saving drugs to the market.Knowledge of chromatography for protein separations, tangential flow filtration, analytical equipment for therapeutic proteins.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.Experience with statistical experimental design (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.

Physical Requirements:

Able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently.Able to work scheduled 40 hours with the ability to work overtime as needed.Comfortable in working in varying temperatures.Ability to gown and work in manufacturing areas, when required.Some reaching, bending, stooping, and twistingRepetitive motion and substantial movement of the wrists, hands, and/or fingers.Environment requires dedicated gowns, depending on area.Work with hazardous materials and chemicals.Willing to work off shift, when required.

Supervisory Responsibilities:  

N/A

Computer Skills: 

MS Office, JMP

Other Qualifications:  

N/A

Travel: 

Some travel may occur as a result of duties assigned to the role

BeiGene Global Competencies

When 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 Clarity

Salary Range: $86,900.00 - $116,900.00 annually

BeiGene 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.

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.