Company description: WuXi 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: QC Bioassay/Biochemical Assay Associate Scientist As QC Bioassay/Biochemical Assay Associate Scientist, you will be part of various technical projects and activities in the QC Bioassay/ QC Biochemical Assay Laboratories.
The site is focused on start-up activities involving commissioning and qualification work, and potential candidates are required to be flexible in this regard.
This also means that 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.
This successful candidate will perform duties across both the QC Bioassay and QC Biochemical Assay Laboratories, but with an emphasis on one.
Organization Description WuXi 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 QC Bioassay/Biochemical Assay Associate Scientist, youll 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, youll be reporting to the QC Bioassay Senior Scientist / QC Biochemical Assay Senior Scientist.
Your Responsibilities Ensure the tasks associated with the start-up and routine operations of a QC Bioassay/Biochemistry laboratory are carried out in a safe manner.
Participate in QC risk assessments, including Quality risk assessment and EHS risk assessment.
Support QC Bioassay/Biochemistry lab set-up, including laboratory design and construction queries, equipment installation and qualification utilizing principles of Operational Excellence and Lean Labs.
Development of training material for the QC Bioassay/Biochemistry Laboratory personnel.
Perform Cell Culture techniques including cell banking, cell revivals, and routine passaging of adherent and suspension lines.
Perform analytical method transfer, validation and routine analysis including but not limited to: Cell Based Bioassays (Potency) Enzyme Activity Assays ELISA qPCR Westen Blot Routine monitoring of laboratory KPIs, stock control of laboratory consumables and reagents and support for future expansion/upgrade projects.
Identify and prepare required GMP documents such as SOPs, protocols, methods, and reports.
Provide effective communication and support project management regarding internal and external clients such as Quality Assurance, Regulatory Affairs, and Analytical Development.
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.
Ability to support regulatory inspections from FDA, EMA, etc.
and cGMP audits from clients, as well as internal audits.
Participate in relevant internal and external QC related audits and site audit readiness.
Ability to work in a team environment and independently as required.
Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi Biologics Policies and Standard Operating Procedures.
Thorough understanding of current Good Manufacturing Practices 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 Bioassay/Biochemical Assay Senior Scientist Will act as a role model for the QC function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.
Your Profile Technical Competencies Bioassay / Biochemistry / Immunoassay techniques including Cell Culture, Bioassay, ELISA, Blotting Techniques, qPCR etc.
Experience Previous experience in a Quality Control / GMP environment is desirable.
Experience with Aseptic techniques.
Experience with the operation of a Biosafety Cabinet (BSC).
Experience with cell culture techniques is desirable.
Experience with Bioassay/ Immunoassay methods is desirable.
Experience with qPCR methods is desirable.
Knowledge Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and / or pharmaceuticals; ICH and GMP guidelines desirable.
Knowledge of routine and non-routine QC testing and techniques and related equipment.
Knowledge of Biosafety requirements, including EPA guidelines on containment and control measures for the use of genetically modified cell lines.
Qualifications Third Level BSc Degree in related science/quality discipline required.
Behavioural Competencies Excellent communication, interpersonal and presentation skills.
Ability to think critically and demonstrate troubleshooting and problem solving skills Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities.
Collaborative and inclusive approach to work and your colleagues.
Excellent problem solving and troubleshooting skills.
Flexible approach to work and a positive attitude will be a good fit within the team dynamic.
Engage cross functionally in conjunction with a site-based team.
Autonomous and a self-starter who will use their initiative to drive actions forward.
Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers' expectations.
Onerous requirements Shift work and business travel may be required for this position as directed by departmental management.
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 WuXi Biologics is an equal opportunities employer.
Skills: Bioassay Biochemistry Immunoassay Cell Culture ELISA Blotting Aseptic Benefits: Bonus Canteen Life Assurance Paid Holidays Parking Pension VHI
