MFG 6.1 Upstream Lead (Associate Director)
The MFG 6.1 Upstream Lead (Associate Director) will play a pivotal role in establishing the Manufacturing Departments for MFG 6.1 by supporting operational readiness. They will provide operations input to ensure the facility design meets end user requirements and latterly, post start-up, by leading the manufacturing team to consistently deliver on specific Key Performance Indicators (KPIs). The Upstream Lead will work closely with the MT and MSAT (Manufacturing Science & Technology) teams to ensure the effective and efficient tech transfer of products and processes to the Dundalk Biologics 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. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. 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, the US, the EU, and Asia. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.
Department Description
As MFG 6.1 Upstream Lead, 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 the Manufacturing Lead.
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.
Supervise daily Upstream manufacturing activities and ensure production timelines are met.
Collaborate with MT and MSAT groups on 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.
Provide working knowledge and technical leadership in cell culture operations.
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 staff 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.
Communicate operational status regularly to senior management, as required, at the appropriate level of detail.
Assist the MFG Lead to coordinate the work between the Upstream 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 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. Masters level qualification.
Knowledge/Experience:
More than 10 years in biopharmaceutical manufacturing with extensive experience in Upstream processing.
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 CIP, SIP, clean room and water system (Purified Water, pure steam, and WFI).
A proficiency in operating a drug substance commercial manufacturing facility and/or a pilot plant.
A strong background in cellular metabolism, various mammalian cell lines, and be scientifically minded.
Hands-on experience with various size bioreactors (both single use bioreactor (SUB) and traditional SS tank) and applying the previously mentioned techniques across those scales is desired.
The individual must have a good understanding in DQ, FAT, SAT, IQ, OQ, & PQ (commissioning and qualification).
Personal skills:
A strong leader with the ability to adapt to daily challenges of a manufacturing work environment while maintaining a 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.
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! If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - don’t miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now!
Would you like to know more before you apply? Please visit us at https://www.wuxibiologicscareers.ie or contact us via talentacquisition@wuxibiologics.com
WuXi Biologics is an equal opportunities employer.