Senior Manager, MFG DSP

Job Title - Senior Manager, Manufacturing DSP

Work Location - Cranbury NJ

WuXi Biologics is a leading global open-access biologics technology platform offering end-to-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 600 customers worldwide, including all the top 20 biopharmaceutical companies

Job Summary

Reporting to the Manufacturing Director, the MFG DSP Manager / Senior Manager, will play a pivotal role in establishing the Manufacturing Department by supporting operational readiness and leading the manufacturing team to consistently deliver on specific Key Performance Indicators (KPIs). The MFG DSP Manager / Senior Manager 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 a team of Supervisors and 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.

Collaborate with MSAT and engineering teams on technical transfer, process validation, 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.

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.

Communicate operational status regularly to senior management, as required, at the appropriate level of detail.

Assist the Manufacturing Director to coordinate 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

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, 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 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

Must be willing to travel as required internationally to fulfil the responsibilities of the position.

The anticipated base pay range for this position is $90,000-140,000

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