A true single-source provider from concept to commercialization for biologics produced from mammalian cell culture.
As a QC Separations Scientist, you will be part of various technical projects/activities in the QC Separation group of 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.
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, providing our clients with a world-leading open access technology platform. 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 a QC Separations Scientist, you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. You’ll be reporting to the QC Separations Team Lead.
Your Responsibilities
* Participate in QC Separation 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/IC (Size Exclusion, Ion Exchange, Reverse Phase, Hydrophobic Interaction etc), CE, cIEF and UV.
* 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 Separation 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, ensuring tasks are performed in a safe manner.
* Maintain high Quality, Compliance and Safety system in a Drug Substance GMP Laboratory.
* Participate and lead various lab deviation and investigation processes such as OOS, OOT and non-conformance, including the implementation of CAPAs and change control.
* Develop training processes for QC Separation, train and coach Separation 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.
Person Specification
* 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/Ion Chromatography, Electrophoresis and Spectroscopy is required.
* Experience with training and coaching of personnel.
* Experience working in a Biologics QC Chemistry testing or Protein Separation Lab involving method transfer and validation is strongly desirable.
* Previous experience with start-up Biologics Laboratory 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.
* Ability to work in a team environment and independently.
* Excellent interpersonal, verbal, and written communication skills.
* 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.
* Travel may be required for this position as directed by departmental management.
WuXi Biologics is an equal opportunities employer.
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