Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
Your role:
The Senior Analytical Scientist will have scientific expertise in biologics drug product Lot Release Testing (LRT) for Analytical. This position will ensure projects are carried out with the appropriate scientific and regulatory compliance oversight. They will also provide their scientific expertise to support investigations and client meetings. The Scientist will have the technical expertise to advice and support GMP operations. Responsibilities include reviewing proposals, acting as responsible scientist on complex technical projects, responding to routine assay enquiries, reviewing and monitoring assay performance and lead scientific trouble shooting discussions during investigations. They will maintain an in-depth understanding of Contract Testing Services, BioReliance® services and technical principles as well as advances in the field.
The ability to maintain effective working relationships with development services, commercial, SMEs from global CTS and laboratory personnel will be critical for success in the role.
The Scientist will be able to perform the following functions independently, with minimal guidance.
Brief role description:
- Lead new assay and technology transfer
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STUDY: Acts as a Responsible Scientist for routine and complex assays and as such holds responsibility for the overall conduct of GMP studies respectively
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Plans, organises and prioritizes workload ensure testing are conducted timely and effectively issuance of studies Certificate of Analysis (COA)
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Ensure routine and complex client studies are completed on time, to the appropriate scientific and regulatory standards
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Works with Lab Manager/Manager on testing schedule for laboratory personnel
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Works within the laboratory areas providing hands-on support, training, guidance, and mentorship to laboratory personnel
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Leads by example, acts as subject matter expert, offers scientific coaching and mentoring to other scientific laboratory personnel
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Author, Reviewer and Approval for study and other technical scientific documents, such as amendments, Scientific protocols, Standard Operating Procedures (SOPs), workbooks, technical specification
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Designs, directs and leads complex projects related to area of operational expertise
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Ensures trending spreadsheets are completed in a timely manner for all studies in accordance with relevant SOP
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Author and reviewer of assay risk assessments related to area of operational expertise
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Ensures all assays / processes are in a validated state in line with current regulations
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Responsible for maintenance and scientific integrity of routine and non-standard assays methods by monitoring assay performance and advising and implementing on improvements where necessary
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Leads process improvements within the laboratory to improve quality and performance
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Performs regular housekeeping laboratory check and Health and Safety audits
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Host internal Quality Audit representing the laboratory; participate in client or regulatory audit
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Responsible on audit observations response through the BioReliance Quality System.
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Lead and ensure deviation and Corrective or Preventative Action (CAPA) records in a timely manner
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Raise and progress Change Control for new service, testing, assay validation introduction
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Acts as scientific consultant to support departmental investigations, client product queries, supplier audits and client/regulatory inspections
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Liaises with Commercial, Development Services, Programme Management and other Laboratory Operations to provide technical support for ongoing and upcoming projects/studies, as required
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Acts as point of contact for routine study enquiries
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Works with Development Services to review proposals for projects
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Write Genetically Modified Organism (GMO) risk assessments.
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Ensures a safe and healthy work environment at all times by not only complying with but actively embracing health and safety policies and procedures, ensuring the safety of yourself and others within the workplace
Who you are:
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Master’s degree or above in Biological Sciences or relevant scientific subject
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Minimum 8 years of experience in a scientific laboratory role, ideally within a GMP contract testing laboratory environment
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Demonstrable scientific expertise in molecular biology related works
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Experience of working in Biosafety Level 2 laboratory
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Computer literacy and entry of data into databases (LIMS, ELN, SAP, Oracle, etc.)
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Ability to complete documentation (both handwritten and electronic) neatly and accurately
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Strategy and business knowledge
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Demonstrates customer centricity
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Thinks and acts strategically
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Can troubleshoot effectively
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Understands the business
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Operating skills
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Puts safety first by adhering to health and safety procedures and actively takes necessary action when encountering unsafe situations
- Orchestrates multiple activities in parallel to accomplish goals
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Plans workload by assigning tasks appropriately depending on length and difficulty of task
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Through effective communication, provides the information people need to know to do their jobs
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Experience with some or all of the following technical disciplines:
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Liquid Chromatography (SEC, RP, IEX, etc.),
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Mass Spectrometry (Intact Molecular weight, Peptide mapping, Disulfide mapping, Glycan Profiling, N-/C-Terminal Sequencing)
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Capillary Electrophoresis Methods (CE-SDS, cIEF)
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qPCR
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Compendial assays, etc.
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Pursues everything with energy, drive and the need to finish, especially in the face of resistance or setbacks
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Can be counted on to achieve goals, constantly and consistently, pushes self and others for results
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Deals effectively with pressure; remains optimistic and persistent, even under adversity
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Relates well to all kinds of people in the organization, builds constructive and effective relationships using diplomacy and tact
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Is seen as a team player, cooperative, easily gains support of peers, encourages collaboration
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Communicates effectively with others
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Handles conflict effectively
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
