MFG 6.2 Upstream Lead

Job description
Upstream Lead
- Associate Director The Upstream Lead
- Associate Director will play a pivotal role in leading the Upstream Manufacturing organization responsible for talent development, operational readiness & the safe, compliant routine manufacturing execution. The Upstream Lead will work closely with the Tech Ops and MSAT (Material Science & Technology) teams to ensure the effective and efficient tech transfer of products and processes to the Dundalk Facility. Organization Description: WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, US, EU, and Asia. We currently employ over 14,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies. Department Description As Upstream Associate Director, you will be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will report to Manufacturing Lead
- MFG 6/7. Your Responsibilities Essential duties and responsibilities of this role include and are not limited to:
• Key member of Manufacturing leadership team for WuXi Biologics Ireland. Will play an important role in the strategy and business planning processes, ensuring cross functional collaboration and leadership execution.
• Support the execution of the overall Manufacturing strategy aligned with the facility’s strategic business plans and global Manufacturing strategy.
• Lead a team of Shift Leads, Specialists and Bioprocess associates to execute routine manufacturing activities in the commercial scale manufacturing of therapeutic proteins in a mammalian cell culture facility.
• Working as function sponsor to collaborate with Tech Ops and MSAT groups on new project technical transfer and process validation
• Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections.
• Schedule and/or deliver 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 Upstream 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 or coordinate the operation excellence and manufacturing excellence work with lean management tool, e.g. problem-solving process (PSP), Standard Work (SW), Kaizen.
• Communicate operational status regularly to senior management, as required, at the appropriate level of detail.
• Assist the MFG 6 / 7 Lead to coordinate the work between the Upstream groups and other functional groups to meet the production objectives and timelines, client audit and agency audit.
• 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 MFG Lead
• 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.

Your Profile
The ideal candidate for this position will have the following:

Education:
• BSc, MSc or PhD in Chemical Engineering, Bioscience, or Biotechnology required
• Qualification / Training in People Leadership is highly advantageous. Technical Knowledge/Experience:
• Prior 3-5 years of manufacturing experience working within Upstream Operations with a knowledge of associated unit operations required in Biopharmaceutical / Vaccine industry.
• Breath of experience required. Candidate must have well rounded end to end experience in roles covering C&Q, Manufacturing Operations, Manufacturing Support/Tech Ops (Leading scientist teams) with experience in supporting functions such as QC or QA highly advantageous.
• Strong Financial Acumen. Prior experience leading/owning department level budgets including preparation, latest forecast & multiyear scenario planning required. Demonstrated leadership of financial project highly advantageous (R&D Tax Credit, Discard Reduction etc).
• Prior People Leadership Experience Required with a demonstrated ability to develop & grow talent.
• Prior biopharmaceutical manufacturing with strong working knowledge of Upstream processes. Ideal candidate will be experienced with Single Use System manufacturing.
• Prior experience leading MFG Support / Tech Ops teams responsible for Compliance Deliverables including Deviations, Change Controls and Risk Assessments for department required.
• Knowledge of CIP, SIP, clean room and water system (Purified Water, pure steam, and WFI). Knowledge:
• A proficiency in operating a drug substance commercial manufacturing facility and/or a pilot plant.
• Hands-on experience with cell culture operations including BSC operations, Cell expansion and Single use bioreactors operations required.
• The individual need to have good understanding in FAT, SAT, IQ, OQ, & PQ (commissioning and qualification). 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 Onerous requirements
• Must be willing to travel as required internationally to fulfil the responsibilities of the position. Closing Date for Applications: Monday 2nd November at 5pm As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential Apply now WuXi Biologics is an equal opportunities employer. Would you like to know more before you apply? Please visit us at https://www.wuxibiologicscareers.com