About the Company
WuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions for biologics discovery, development, and manufacturing. Our mission is to enable our partners to deliver innovative medicines to patients worldwide. We foster a culture of collaboration, integrity, and excellence.
About the Role
Reporting to the Manufacturing Head, this position is the lead role for the Fed-Batch Single Use facility in the Manufacturing Department of the WuXi Biologics Manufacturing Organization. The role is an integral part of the Manufacturing Department, responsible initially for the establishment of the facility during construction and commissioning and latterly the long-term leadership to ensure all customer requirements are delivered on time and in full.
Responsibilities
- Key member of Manufacturing leadership team for WuXi Biologics. The incumbent will play an important role in the strategy and business planning processes, ensuring cross functional collaboration and leadership execution.
- The role will require extensive liaison with counterparts and business leaders in WuXi Biologics corporate to include the highest level of professional representation of the local site Manufacturing organization.
- Support the development of the overall Manufacturing strategy aligned with the facility’s strategic business plans and global Manufacturing strategy.
- Build the newly formed Mfg Organization in Dundalk establishing clear team identity, roles and responsibilities and hand offs with other functions
- Supervisor to the Mfg Upstream Lead, Mfg Downstream Lead, Mfg Inoculation Lab and Cell bank Lead and the Mfg Manufacturing Technology Lead.
- Provide oversight of the design, construction and qualification of the Mfg facility in Dundalk.
- Serve as drug substance (inclusive of Upstream cell culture and Downstream purification) process subject matter expert, providing technical oversight to teams, and coaching to associate staff.
- Technical Point of Contact for customers.
- Responsible for the preparation and management of the annual budget.
- Providing technical and commercial leadership of:
Oversight of day-to-day Upstream and Downstream manufacturing activities ensuring production timelines are met.
Collaboration with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections.
All product quality related investigations and corrective or preventative action recommendations relating to production management activities
Equipment, Facility and Documentation Changes within the facility.
Collaboration with MSAT, Process Development and Project Management groups on technical transfer and process validation
New Product Implementation, including scale-up, through technology/process transfer to clinical and commercial manufacturing.
Providing technical input to manufacturing process validation plans, protocols and reports.
Supporting all RFP business requests with required facility fits and technical information.
Ensuring 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.
Collaborate closely to assist the Manufacturing Director in coordinating the work between the Mfg group and other functional groups to meet the production objectives and timelines.
Authoring and reviewing standard operating procedures and technical reports.
Support multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus.
- Perform all duties in accordance with GMP requirements, SOPs and controlled documents
- Flexibility 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 organization in adherence to the WuXi corporate core values and PROUD culture.
Qualifications
- BSc/MSc in a scientific or engineering discipline or equivalent is preferred.
- Masters level qualifications is advantageous.
Required Skills
- Ideally, experienced in establishing a Manufacturing facility and large scale design and construction project in a ‘greenfield’ context of similar size and scale.
- Demonstrated success in scientific and technical proficiency, bioprocess implementation, cGMP operation, and teamwork.
- More than 15 years working in a cGMP biological manufacturing environment with previous experience managing and/or leading functional and project teams.
- Experience across both Upstream and Downstream manufacturing activities.
- Greenfield or large site expansion experience is beneficial.
- Experience working with lean principles and implementing CI processes within a complex manufacturing operation.
Preferred Skills
- Must have a proven track record of extensive manufacturing knowledge and experience gained within the biopharmaceutical/pharmaceutical industry sector.
- Significant expertise in manufacturing processes and systems.
- Proven track record in delivering large scale manufacturing projects.
Pay range and compensation package
Compensation details will be discussed during the interview process.
Equal Opportunity Statement
WuXi Biologics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.