Job Title - Associate Director, Downstream Manufacturing
Work Location - Cranbury NJ
Job Summary
Reporting to the Manufacturing Director, the Associate Director, Downstream Manufacturing, will play a pivotal role in leading the Downstream Manufacturing Department by supporting operational readiness and leading the manufacturing team to consistently deliver on specific Key Performance Indicators (KPIs). The Associate Director, Downstream Manufacturing will work closely with the MSAT (Manufacturing Science & Technology) teams to ensure the effective and efficient tech transfer of products and processes to the MFG18 Cranbury Facility.
Responsibilities
- Member of Manufacturing leadership team for WuXi Biologics USA.
- Support the execution of the overall Manufacturing strategy aligned with the facility’s strategic business plans and global Manufacturing strategy.
- Lead Manufacturing Bioprocessing Associates to execute routine manufacturing activities of therapeutic proteins in a mammalian cell culture facility.
- Manage daily downstream manufacturing activities and ensure production timelines are met.
- Oversee column packing activities and equipment changeover to ensure manufacturing readiness.
- Lead and/or support cross-functional task forces driving quality system improvement.
- Represent as MFG Funtional Lead to conduct technical transfer and engage cross-department communication to assure GMP readiness when needed/assigned. Oversee production campaign and serve as process expert on the floor, acting as MFG SME for internal and external communication.
- 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.
- Schedules and/or delivers training to manufacturing personnel to ensure staff can perform manufacturing operations safely and compliantly.
- Motivate, retain, develop existing group members and recruit new staffs to build a strong Downstream manufacturing team
- Contribute to continual improvement of all manufacturing documentation (SOP’s MBR’s, OJT’s) to ensure they are current, accurate, and clear. Lead procedure harmonization with Clinical MFG platform when needed
- Communicate operational status regularly to senior management, as required, at the appropriate level of detail.
- Assist in coordinating the work between the Downstream groups and other functional groups to meet the production objectives and timelines.
- Perform all duties in accordance with GMP requirements, SOPs and controlled documents
- Will be flexible to take on additional tasks and responsibilities at the discretion of the Manufacturing Director
- Will act as a role model for the Manufacturing function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.
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 advantageous
- Comprehensive knowledge and experience of relevant cGMP, safety and environmental regulations within the biopharmaceutical industry
- Ideally, experienced in establishing a Manufacturing department and building a team of similar size and scale.
- 10+ years in biopharmaceutical manufacturing with extensive experience in Downstream processing.
- Experience in the large-scale chromatography, column packing, ultrafiltration/diafiltration, viral inactivation, filtration, etc.
- Experience managing and leading manufacturing personnel.
- 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 the cross-functional teams.
- Experience in troubleshooting and investigation of the critical deviation, and making the risk analysis on the development, technical transfer and process validation.
- Must be quality focused with knowledge and understanding of cGMP quality systems and how they apply to manufacturing operations.
- 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 advantageous.
Behavioural 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 organisation.
- Ability to work on own initiative and be proactive.
- Results oriented, with the ability to manage multiple priorities in a short period of time.
- Excellent organisational 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. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.
WuXi Biologics is 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 on the basis of disability