Job Title – Director of Manufacturing
Work Location - Cranbury NJ
WuXi Biologics is a is a leading global open-access biologics technology platform offering end-of-the-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics’ achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity, and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than six hundred customers worldwide, including all the top 20 biopharmaceutical companies.
Job Summary
The Director of Manufacturing will play a pivotal role in leading the Manufacturing Department by supporting operational readiness and driving the manufacturing team to consistently deliver on specific Key Performance Indicators (KPIs). The MFG Director will work closely with Site leadership to ensure successful technical transfer and manufacturing.
Responsibilities
- Member of Manufacturing Leadership team for WuXi Biologics USA.
- Design and drive the execution of the overall Manufacturing strategy aligned with the facility’s strategic business plans and global Manufacturing strategy.
- Lead a team responsible for managing daily downstream manufacturing activities and ensure production timelines are met.
- Collaborate with global teams and local teams on technical transfer, facility fit and GMP readiness, etc.
- Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections.
- Provides working knowledge and technical leadership in Downstream operations.
- Motivate, retain, develop existing group members, and recruit new staffs to build a strong Downstream manufacturing team.
- Lead the continual improvement of all manufacturing documentation (SOP’s MBR’s, OJT’s) to ensure they are current, accurate, and clear.
- Coordinate the work between the Downstream groups and other functional groups to meet the production objectives and timelines.
- Will act as a role model for the Manufacturing function and the wider organization in adherence to the WuXi corporate core values and PROUD culture.
- Drive WuXi Biologics System (WBS) process improvements.
Qualifications
- Certificate, Diploma, Degree in Science, Engineering or related field or equivalent experience in the biopharmaceutical industry is essential.
- BSc, MSc or PhD in Chemical Engineering, Bioscience, or Biotechnology is preferred.
- Comprehensive knowledge and experience of relevant cGMP, safety, and environmental regulations within the biopharmaceutical industry
- Experienced in establishing and leading a Manufacturing department and building a team of comparable size and scale.
- 10+ years in biopharmaceutical manufacturing with extensive experience in Downstream processing.
- Experience in the large-scale chromatography, ultrafiltration/diafiltration, viral inactivation, filtration, etc.
- Experience in dealing with FDA, and/or EMA, and have a solid understanding of quality system in terms of deviation, investigation, CAPA and change control.
- Experience in working with cross-functional teams.
- Experience in troubleshooting and investigation of the critical deviation, and making risk analysis on the development, technical transfer, and process validation.
- Knowledge of Lean Six Sigma methodology
Behavioral Competencies
- A strong leader with the ability to adapt to daily challenges of a manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among direct reports.
- Excellent verbal and written communication and presentation skills.
- Excellent interpersonal skills with the ability to work effectively with staff at all levels of the organization.
- Ability to work on own initiative and be proactive.
- Results are oriented, with the ability to manage multiple priorities in a brief period of time.
- Excellent organizational and planning skills and strong attention to detail
The job description does not intend to list all the duties and responsibilities assigned to this position. Employees holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.