Staff Scientist, Manufacturing Science & Technology, Cell Culture

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 (Cell Culture). This position is a critical role within the MST Cell Culture laboratories and requires extensive knowledge and experience of the following areas: Media Preparation, Inoculum, Seed/Production Cultivation and Harvest process. The position will be responsible for the design, execution and review of laboratory experiments, data analysis and authoring of various reports. 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 and reviewing department standard operating procedures, training junior staff, maintaining raw material and consumable inventory within the lab.

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

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 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 Job Functions

• Provide technical support and guidance as SME for implementation of cell culture processes.
• Lead and 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.
• Perform manufacturing data analysis as required.
• Author and review study protocols and reports, and other documentation supporting deviations and regulatory activities.
• Participate in and support on-site supervision and management of contract employees or third parties as required by BeiGene.
• Responsible for execution of laboratory experiments and maintaining support laboratory activities.
• Perform Continued Process Verification (CPV) and process monitoring during campaigns.
• Effective communication with team members and stakeholders is a must.
• Perform tech transfer activities, including facility gap and risk assessments.
• Author and review technical transfer plans, process descriptions, control strategies, and campaign summary reports.
• Serve as Person-In-Plant (PIP) during critical steps of the manufacturing process, when required.
• Author and review Process validation plan, PPQ protocols, and various upstream study protocols to support PPQ.
• Any other assignment as is determined by the manager.
• Ensure a safe working environment.

Education Required

• BS, MS, or PhD in biochemistry, Pharmaceutics, Pharmaceutical Science, biology, biotechnology, chemical engineering and/or related discipline.

Required Qualifications

• Knowledge of drug preclinical, clinical and commercial requirements.
• Experience with software such as Microsoft Office, Microsoft project, Visio, SAP, etc.
• Demonstrated experience working in cell culture laboratory.
• 8 plus years overall experience is preferred.
• Broad knowledge of drug development, CMC, MST, preclinical and clinical requirements.
• Demonstrated skill in leading project teams tasked with resolving complex production related issues.
• Experience in effectively managing scientific groups and projects.
• BS with 5 plus years, MS with 4 plus years, or PhD with 2 plus years of manufacturing experience in the Life Science/Biotechnology industry.
• Effective communication, oral and written, in a multi-disciplinary, project-driven work environment.
• Familiarity with EMA and FDA regulatory requirements for submissions.

Technical/Skills Required

• Experience with upstream process design, optimization, and tech transfer to clinical/commercial manufacturing facilities.
• Excellent understanding of GMP requirements.
• 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.
• Proven planning and data analysis skills, use of statistical software to analyze data
• Ability and aptitude for analyzing data, detecting inconsistencies, determining relative importance, and utilizing data and risk analysis tools.
• Expertise with study design such as DOE and authoring of study protocols / reports.
• Expertise with inoculum processes, bioreactor systems, harvest processes and analytical equipment.
• Project management skills related to internal and external teams
• Knowledge of regulations and guidelines of FDA, EMA, ICH, PDA.

Physical Requirements

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

Supervisory Responsibilities

• Supervisory experience preferred

Competencies

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.

Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

Project Management - Communicates changes and progress; Completes projects on time and budget.

Salary Range: $106,200.00 - $146,200.00 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.