Supervisor, Cell Culture Operations (Hopewell, NJ)

BeiGene • Hopewell, VA

6h

About The Position

BeOne 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: Reporting to the Head of DS Manufacturing Cell Culture. This position plays a leading role in troubleshooting processes, building a detailed understanding of them, and driving process robustness and meeting manufacturing timelines by setting clear objectives and empowering their team. This position involves consistent collaboration with Cell Culture MSAT, DS Manufacturing Purification, Facilities & Engineering, Quality Control, Quality Assurance, Regulatory groups. This position requires through knowledge in mammalian cell culture processes and some exposure to protein purification and protein product quality attributes. Of equal importance is the ability to lead and develop reports. Essential Functions of the Job: Leading, mentoring and development of staff is a critical part of the responsibility, with an aim to empower team members to a level commensurate with their skills and experience. Participate in cross-functional projects teams Ensure a safe working environment Effective communication with team members and stakeholders is a must Participate in and support on-site supervision and management of contract manufacturers as required by BeiGene.

Requirements

• CIP & SIP of fixed stainless-steel vessels and transfer lines
• Solution preparation and transfer
• Single Use Technologies (mixers & bioreactors)
• Seed lab operations: passaging and scale-up
• Bioreactor wave and shaker flask
• Bioreactor operations
• Harvest operations
• Sterile Filtration / Integrity testing
• Analytical Instrumentation (pH, osmometer etc.)
• Good Documentation Practices
• Equipment and process troubleshooting
• Authoring SOP’s, MBR’s & WI’s
• Delivering technical presentations
• Quality Risk Assessments
• Health Authority Interaction/Audits
• Resource Modeling
• OE and/or LEAN Methodologies
• Distributed Control system / Control Systems
• Deviations, assessments, investigations & CAPA’s
• SAP, LIMS, CMMS, Veeva
• BA/BS or higher in science, biochemistry, biotechnology, biology, chemical engineering and/or related discipline.
• Minimum of 2+ years of experience in the Life Science/Biotechnology.
• Minimum of 1+ years supervisory experience in biopharma industry
• Knowledge of GMP & GDP drug preclinical, clinical and commercial requirements.
• Familiarity with EMA and FDA regulatory requirements.
• Effective communication, oral and written, in a multi-disciplinary, project-driven work environment.
• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

Responsibilities

• Leading, mentoring and development of staff is a critical part of the responsibility, with an aim to empower team members to a level commensurate with their skills and experience.
• Participate in cross-functional projects teams
• Ensure a safe working environment
• Effective communication with team members and stakeholders is a must
• Participate in and support on-site supervision and management of contract manufacturers as required by BeiGene.
• 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
• Self-directed leadership within both predicable and ambiguous work environments
• 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

Benefits

• All Company employees have the opportunity to own shares of BeOne Medicines 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees