Senior Scientist

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 into the Associate Director of Manufacturing Sciences & Technology (Purification). The position plays a critical role within the MST Purification laboratories and activities, included but not limited to chromatography, filtration (tangential flow, depth, viral and dead end), and therefore previous experience is required. The position will be responsible to lead the design and execution of laboratory experiments, data analysis and authoring of various reports. Position will support technology transfers activities, including but not limited to mass balance calculations, buffer calculations and assignment, bill of materials generation, facility fit and material gap analysis, manufacturing process flow diagrams, and authoring of process description and process control strategies. In addition, this position will support process improvements, troubleshooting, compliance related activities and provide technical support to manufacturing.

The position also will play a leadership role within the laboratory, and as such will be responsible in authoring department standard operating procedures and ensure the training of junior staff, maintaining raw material and consumable inventory. The position will support regulatory filing, through authoring of required regulatory sections, answering to regulatory authority questions and participate in various internal and external regulatory inspections.

Working in MST laboratory 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 various phases of the Green-Field Project to becoming fully operational, it provides unique opportunities and challenges to anyone who is looking for career advancement.

Essential Functions of the job:

• 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 design and 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 cell culture processes.
• Author technical transfer plans, process descriptions, control strategies, and campaign summary reports.
• Author Process validation plan, PPQ protocols, and various upstream study protocols to support PPQ.
• Perform Continued Process Verification (CPV) and process monitoring during campaigns.
• Effective communication with team members and stakeholders is a must.
• Serve as Person-In-Plant (PIP) during critical steps of the manufacturing process, when required.
• Perform manufacturing data analysis as required.
• Participate in and support on-site supervision and management of contract employees or third parties as required by BeiGene.
• Any other assignment as is determined by the manager.

Core Competencies, Knowledge and Skill Requirements

• BA/BS or higher in science, biochemistry, biotechnology, biology, chemical engineering and/or related discipline
• Minimum of 4 years of experience in the Life Science/Biotechnology
• Demonstrated experience working in purification laboratory
• Knowledge of drug preclinical, clinical, and commercial requirements
• Familiarity with EMA and FDA regulatory requirements for submissions
• Effective communication, oral and written, in a multi-disciplinary, project-driven work environment
• Experience with software such as Microsoft Office and SAP
• 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 data
• Project management skills related to internal and external teams
• Knowledge of regulations and guidelines of FDA, EMA, ICH, PDA.

Physical Requirements:

• Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently.
• Must be able to work scheduled 40 hours with the ability to work overtime as needed.
• Must be comfortable in working in varying temperatures.
• Ability to gown and work in manufacturing areas, when required.
• Some reaching, bending, stooping, and twisting
• Repetitive 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.

Computer Skills: MS Office, JMP

Other Qualifications: N/A

Travel:

• Must be willing to travel approximately 10%.

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 Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $92,200.00 - $127,200.00 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.