Supervisor, Cell Culture Operations

BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. Currently employees are located in APAC, Americas, and Europe. BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients. For more information, see www.beigene.com. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. At BeiGene, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things. Patients First Bold Ingenuity Collaborative Spirit Driving Excellence 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. This position reports directly to the Sr Manager of Drug Substance and requires effective leadership, coaching and performance management of 5-15 bioprocess technicians responsible for facility start-up and execution of cGMP cell culture operations. The Cell Culture Supervisor will be responsible for actively directing and engaging in work to support the following two phases of the Hopewell manufacturing facility: Facility start-up and CQV execution High volume reliable cGMP Manufacturing Required Leadership Skills (Phase I & II) Strategic and tactical planning with ability to convey business relevance to team Ability to translate strategy into actionable goals and expectations for team members Consistently delivers tangible business that support organizational objectives via self and direct reports Leading, directing, coaching/developing, and providing timely feedback to direct reports Planning and managing day to day activities, including staff availability and task load Writing and delivering effective performance appraisals Consistently receives and provides feedback thoughtfully Planning and managing day-to-day activities, including resources and task loading Self-directed leadership within both predicable and ambiguous work environments Deviations, assessments, investigations & CAPA’s Inclusive and cross-functional collaboration with all levels Ability to cultivate culture of continuous improvement and right first-time quality Thoughtfully escalates issues/concerns in a timely manner as appropriate Project management and working through competing priorities Recruiting, interviewing, and selecting key talent Required Skills/Experience CIP & SIP of fixed stainless-steel vessels and transfer lines Solution preparation and transfer Bioreactor operations Harvest operations Sterile Filtration / Integrity testing Sampling Analytical Instrumentation (pH, osmometer etc.) Good Documentation Practices Equipment and process troubleshooting Authoring SOP’s, MBR’s & WI’s Delivering technical presentations Preferred Skills/Experience Facility Start-Up Commissioning, Qualification & Validation Equipment and/or Process Design Autoclaves and Washers Single Use Technologies (mixers & bioreactors) Seed lab operations: passaging and scale-up Bioreactor wave and shaker flask Quality Risk Assessments Health Authority Interaction/Audits Resource Modeling OE and/or LEAN Methodologies Distributed Control system / Control Systems Deviation Assessments / Investigations SAP, LIMS, CMMS, Veeva Professional Experience Bachelor’s Degree: Science / Engineering or equivalent experience in biopharmaceutical industry 2 years of experience working in Biopharmaceutical manufacturing 1 years supervisory experience in biopharma industry Physical Requirements: Must be able to stand for long periods, up to 8 to 10 hours/day Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently Must be able to work scheduled at least 40 hours/week Must be comfortable in working in varying temperatures Frequent lifting, pushing, pulling, and carrying. Ability to lift up to 40 lbs Regular 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 any shift Computer Skills: Familiarity with computer-based systems. Word, Excel, and PowerPoint a must. Other Qualifications: Health authority inspections (FDA, EMA, ICH regulations and guidelines). Execution and optimization of controlled procedures. Technical and business writing. Business process development. Travel: International and domestic – periodically. 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. 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.