Manufacturing Buffer Lead (Associate Director)

WuXi Biologics Group; Ireland; On-site; EUR 40,000 - 60,000; Full time

Job summary

A leading biologics services provider in Ireland is seeking a Manufacturing Buffer Lead (Associate Director) to oversee batch production and ensure compliance with GMP standards. The role involves coordinating operations, mentoring team members, and collaborating across departments. Candidates should have an engineering degree, proven leadership in manufacturing, and experience with biologics processes. This position offers an opportunity to contribute to a pioneering company transforming drug development and manufacturing.

Qualifications

• Experience in GMP and cross-functional project management.
• Postgraduate qualification in an engineering or science discipline is advantageous.

Responsibilities

• Coordinate and execute batch production activities ensuring cGMP compliance.
• Develop team members and maintain safety education.

Skills

Strong team leader

Excellent verbal and written communication

Results oriented

Technical knowledge of biologics processes

Education

B.Eng or B.Sc in Chemical or Process engineering

Job description

Manufacturing Buffer Lead (Associate Director)

The Manufacturing Buffer Lead will play a pivotal role in the Manufacturing department. This role will align with Manufacturing Shift Leads, providing support to ensure the efficient and successful execution of production and associated GMP activities.

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.

Department Description

As Manufacturing Buffer 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 Senior Director.

Your Responsibilities

• Responsible for Buffer to ensure and complete batch production activities under cGMP compliance. Under limited supervision, can independently coordinate the execution of projects and lead operations to accomplish production on schedule.
• Ensure following EudraLex GMP and all applicable cGMP guidelines.
• Communicate status of process, personnel, safety, environment, maintenance, and other issues, in a timely manner to regularly to management required, at the appropriate level of detail.
• Keep a safe environment in cGMP facility. Responsible for the safety education and supervision of team members.
• Coordinate with QA to ensure GMP compliance, mange change controls, deviation investigation and CAPA implementation, and support client audit and agency inspections.
• Collaborate with MSAT/PEV and related groups for technology transfer and validation.
• Author and review GMP documents including, but not limited to SOP/MBR/URS/FAT/SAT, as well as review the executed batch record.
• Responsible for ensuring all team member training is up to date, and qualified to perform the operation per cGMP compliance.
• Responsible for mentoring and developing team members and build a strong team.
• Take initiative to optimize the operation and continuous improvement. Responsible for daily management within the group and department.
• Create a positive team culture, motivate, retain, and develop existing team members and recruit new employees.
• Will be flexible to take on additional tasks and responsibilities at the discretion of the Manufacturing Senior Director.
• Will act as a role model for the Manufacturing function and the wider organisation in adherence to the WuXi Biologics corporate core values and PROUD culture.

Your Profile

The ideal candidate for this position, will have the following:

Education

• B.Eng or B.Sc in Chemical or Process engineering or equivalent is required.
• A postgraduate qualification in an engineering or science discipline would be advantageous.

Knowledge/Experience

• Technical / Engineering knowledge of Upstream and Downstream biologics processes is desired.
• Knowledge / experience in the operation of GMP.
• Experienced in the management of complex cross functional projects.

Personal skills

• A strong team 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.
• Results oriented, with the ability to manage multiple priorities in a short period of time.
• Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers’ expectations.
• Must be willing to travel as required internationally to fulfil the responsibilities of the position.

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 athttps://www.wuxibiologicscareers.ieor contact us [e-mail]. WuXi Biologics is an equal opportunities employer.