Bioprocessing Shift Lead

Company description: Wu Xi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries.
Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide.
The company has sites/offices in China, US, EU, Asia and Israel.
The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies.
Job description: As Bioprocess Shift Lead MFG 6.2 US you will be responsible for supporting all operational readiness activities to ensure the facility design meets end user requirements.
Upon successful commencement of commercial operations, the role will evolve to leading a team of highly trained professionals in the manufacture of biological products in adherence to the highest standards of quality and regulatory compliance.
The Shift lead will be responsible for the recruitment, development, and retention of the team to consistently deliver on the specific KPIs and to meet with the expectations of our customers.
Organisation Description Wu Xi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries.
Were 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, Asia, and Israel.
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 Bioprocess Shift 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 be reporting to the Manufacturing Associate Director.
Your Responsibilities In this role, youwill be a Key member of Manufacturing leadership team for Wu Xi Biologics Ireland.
Will playan important rolein theexecution of the business plans, ensuring cross functional collaboration and leadership execution.
Responsible for the Bioprocess Associates assigned to the shift on an ongoing basis.
Senior Person on Site during Shift Hours (Weekends and Evenings) with some responsibility over shift personnel in Maintenance and support functions during this time.
Supervision on a day-to-day basis, training and communications, assignment and prioritization of work, delivery of objectives, performance management including development of direct reports, resolution and escalation of grievances and disciplinary issues.
Responsible for emergency procedures, safety systems, safety performance, communication, and behaviours on the shift.
Performs safety audits and walk downs as required.
Participates in HAZOPs and reviews safety documentation as required.
Liaises with statutory agencies when required.
Reports and leads the investigation of safety or environmental incidents on the shift and records, reports and resolves/escalates unsafe conditions or near misses that are observed.
Acts as Area Owner for the Permit to Work system in manufacturing during normal day shifts and in all areas across site in the out of hours.
Ensures that the plant and equipment is operating in a compliant manner and that all activities are conducted to meet GMP regulations, site and corporate quality standards and any additional regulatory requirements as required.
Provide technical support to the MFG Shift team as required.
Provide instruction, training, and guidance to the Shift team during MFG operations.
Execute production activities where required to support training and development of personnel.
Reports and investigates batch deviations or quality issues on the shift and escalate issues promptly.
Raises change controls and emergency change controls where required.
Oversees the review of completed documentation and is responsible for RFT on shift.
Conducts any checks, inspections, or audits necessary.
Responsible for housekeeping and audit preparations in assigned areas.
Ensures that relevant risk assessments are completed.
Manage training for their shift team and own the respective training plan.
Assist in maintaining a safety orientated Culture, c GMP compliant work environment always.
Where necessary assist in Facility and Equipment starts up and Validation activities.
Manages day to day operations on shift.
Ensures functional area targets, objectives and performance criteria are understood and met.
Aligns shift activities with changing business needs.
Prioritizes tasks and assigns resources accordingly.
Makes informed technical decisions where appropriate and escalates issues promptly.
Works cross-functionally and cross-shifts to resolve issues and drive improvements.
Responsible for schedule adherence metric on shift; drives performance to ensure throughput and changeover targets are met.
Supports technical transfer activities.
Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products.
Write, review, revise and approve of area SOPs, Batch Records, Logbooks, Training Competencies and Work Instructions Seek opportunities for Continuous Improvementusing Lean/Six Sigma tools as part of daily operations (Standard Work, TPM, 5 S, Method 1, 2 etc.) Always maintain the designated place of work in a clean and tidy state during production activities.
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 Associate Director.
Will act as a role model for the manufacturing functionand the wider organisation in adherence to the Wu Xi corporate core values and PROUD culture.
Your Profile The ideal candidate for this position, will have the following: Education A degree in science, chemical engineering, or a related field is preferred but not essential.
Knowledge/Experience Minimum of 8 years supervisory/leadership experience in the pharmaceutical/biopharma industry in a direct manufacturing support role.
Extensive experience in leading teams, supporting the continued development of employees, motivating, and engaging them to achieve their potential.
Expert experience in dealing with, resolving employee grievances, and always maintaining a positive and progressive work environment/culture.
In-depth knowledge of relevant c GMP, safety, and environmental regulations.
Expert knowledge and experience of the manufacturing equipment and associated processes.
Excellent knowledge of the documentation standards and protocols in a pharmaceutical/biopharma manufacturing environment.
Personal skills Strong leadership 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 organizational 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 - dont 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 ator contact us via Wu Xi Biologics is an equal opportunities employer.
Skills: GMP Management Leadership GDP Benefits: Bonus Educational assistance Pension VHI