QC In Process Team Lead

at  WuXi Biologics

QC IN PROCESS TEAM LEAD

As the QC In Process Team Lead, you’ll lead a range of technical projects and activities in the QC In Process group at WuXi Biologics. The site is focused on start-up activities involving commissioning and qualification aligned with project timelines. As part of the project the role will evolve based on project timelines.

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, 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 the QC In Process Team Lead, you’ll 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’ll be reporting to the QC Associate Director.

EXPERIENCE

• 8+ years experience working within a Quality Control environment, with a well-rounded exposure to all areas in this field. Experience working in the Biologics industry is essential.
• Previous experience managing and leading a small team would be advantageous.
• Experience with LIMS, Empower, ECM, Master Control, Trackwise or similar systems is required.
• Experience with Microsoft Word, Excel, Powerpoint, Visio, and Project is required.
• Management/supervision of personnel with particular attention to schedules and shifting priorities is desirable.
• Previous experience working in a CMO is an advantage.
• Previous experience of shift work / managing a shift team is an advantage.

KNOWLEDGE

• Knowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticals.

QUALIFICATIONS

• University degree in related science/quality discipline required.

In this role, you will be responsible for the following:

• Key member of the QC Team in Dundalk. Will support execution of the strategy and business planning processes, ensuring cross-functional collaboration.
• Support the development of a Biologics QC In Process testing shift team including planning, recruiting/hiring, coaching/mentoring, and training.
• Provide the highest quality analytical support for Biologics manufacturing, while ensuring compliance with cGMP guidelines/regulations, company SOPs, and safety regulations.
• Communicate, collaborate, and cooperate with MFG and QC functional teams and other departments to support site operations.
• Manage In-process team shift rota.
• Team Lead and line Manager for QC In Process Scientist and Associate Scientists, providing guidance and direction, performance management, training plan through scheduling, and direct 1-2-1 with the team.
• Serve as a technical expert supporting applicable non-conformances, atypical/OOS investigations, change controls, deviations, and CAPAs.
• Develop and maintain high level of scientific achievements for the company; expected to be a point of contact for project coordination, including email and client meetings.
• Seek opportunities for continuous process improvements/improved operational excellence.
• Ensure the tasks associated with the start-up and routine operations applicable to the role are carried out in a safe manner.
• Support Risk Assessments for projects and business innovation initiatives
• Ability to work in a team environment and independently as required.
• Aligned with the project timelines managing and leading a team will also be required as part of the role.
• Prepare, review, and approve technical documents including method protocols, qualification and validation protocols and reports, etc.
• Will be flexible to take on additional tasks and responsibilities at the discretion of the QC Associate Director.
• Potential candidates may be required to carry out additional job functions that are not described in this job description but will be associated with the role.