As a QC In Process Scientist, you will be part of a shift team in QC working on various technical projects/activities in 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, and may require candidates to carry out additional job functions not described in the job description but associated with the role.
Organisation Description
WuXi Biologics is a premier provider of biologics services (from discovery to commercialisation) 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 QC In Process Scientist, you’ll be joining an organisation 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 In Process Team Lead.
Your Responsibilities
- This role will involve shift work.
- Participate in QC In Process testing GMP Lab set up, including lab design, construction, and commissioning of the new facility for production of biologics drug substance.
- Perform analytical method transfer, verification/validation and routine analysis using various analytical techniques; including but not limited to HPLC - Reverse Phase and Affinity Chromatography, UV Spectrophotometer – UV-Vis and SoloVPE.
- Working alongside manufacturing shift pattern to support forward processing in-process activities, receipt, and testing of batch samples for protein estimation and concentration.
- Support out of hours QC activities (E.g. sample management, alarm management, FTIR, density analysis).
- Perform data review of analysis, troubleshooting, technical support, and shift lead.
- Participate and Lead activities including general lab readiness, audit readiness, housekeeping, laboratory equipment qualification, routine calibration, and maintenance.
- Prepare and review required GMP documents such as SOPs, protocols, methods, and reports.
- Drive the establishment of required inventory for In-Process team and develop a system for stock control of laboratory consumables and reagents.
- Foster Operation Excellence and continuous improvement environment; including implementing Lean tools (5S, Kanban and Kaizen).
- Participate in Lab risk assessment, including Quality risk assessment and EHS risk assessment, ensuring tasks are performed in a safe manner.
- Maintaining high Quality, Compliance and Safety system in a Drug Substance GMP Laboratory.
- Participate and Lead various Lab deviation and investigation process such as OOS, OOT and non-conformance, including the implementation of CAPAs and change control.
- Develop training process for QC In-Process testing team, train and coach Associate Scientists and other QC personnel.
- General laboratory support such as leading and maintaining a process for housekeeping, inventory,
- Consistently delivering and monitoring specific Lab Key Performance Indicators.
- Other related duties assigned by management.
Your Profile
The ideal candidate for this position, will have the following:
Technical Competencies
- Experience and knowledge of general Quality Control Biologics function and activities.
- Possess knowledge of routine and non-routine QC/in process testing.
- Experience with regulatory/customer audits is desirable.
Experience
- Previous experience from QC Pharmaceutical/Biopharmaceutical using Chemistry analytical techniques; Liquid Chromatography and Spectroscopy is required.
- Experience with training and coaching of personnel.
- Experience working in a Biologics QC Chemistry or In Process testing Lab involving method transfer and validation is strongly desirable.
- Previous experience with start-up Biologics Laboratory is desirable.
- Previous experience working in a Quality Control Laboratory at a senior level is desirable.
- Experience with systems such as Empower CDS, Trackwise and LIMs or related system is required.
- Experience with Microsoft Word, Excel, and PowerPoint is required.
Knowledge
- Knowledgeable of regulatory bodies, FDA/EMA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines is a plus.
- General knowledge of Biologics Drug Substance.
Qualifications
- University degree in related science/quality discipline required.
Behavioural Competencies
- Ability to work in a team environment and independently.
- Excellent interpersonal, verbal, and written communication skills
- Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities.
- Ability to think critically and demonstrate troubleshooting and problem-solving skills.
- Collaborative and inclusive approach to work and your colleagues.
- Flexible approach to work and a positive attitude will be a good fit within the team dynamic.
- Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and client’s expectations.
Other Requirements
- Travel may be required for this position as directed by departmental management.
- This role requires full shift work.
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.wuxibiologics.com/join-us/ or contact us via [email protected]
WuXi Biologics is an equal opportunities employer.
