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Bioanalytical Senior Principal Scientist
1 month ago
Bioanalytical Senior Principal Scientist
Our client, a biotech manufacturing facility, is currently recruiting for a Bioanalytical Senior Principal Scientist to join their team on a permanent basis. As Bioanalytical Senior Principal Scientist in Quality Control, you will provide the analytical leadership for all aspects of bioanalytical technologies and methods. You will be responsible for the provision of analytical methods, data, and information using analytical techniques in supporting site manufacturing processes and network projects.
Responsibilities:
- Lead the introduction, validation and ongoing technical agenda for pipeline and commercial analytical methods and technology.
- Develop and validate robust scientifically advanced methods with the required performance attributes to satisfy stakeholder needs.
- Execute and/or oversee testing protocols in accordance with biosafety, local procedure and regulatory requirements.
- Develop strong links with Global Regulatory Affairs and participate in the preparation and review of regulatory submissions.
- Develop strong links with Bioproducts Research and Development and participate in the development and transfer of new techniques and methodologies.
- Develop strong links with other manufacturing sites to deliver their support needs.
- As required, provide training or mentorship to other QC or cross-functional team members.
- Act as SME for molecular and chromatographic based analytical technologies. This may include the identification, sourcing, installation, and qualification of new equipment.
- Assure that all samples are appropriately received, stored, analyzed and disposed of appropriately. This also includes testing outsourced to third parties.
- In the event of non-conformance to acceptable quality and/or safety standards, lead and document analytical investigations using Root Cause Analysis techniques where appropriate. Ensure all associated countermeasures are appropriately implemented.
- Keep abreast of relevant scientific literature, new technologies/capabilities and regulatory initiatives/requirements and support their implementation, as appropriate.
- Support the writing of Annual Product Reviews (APRs) and Laboratory Periodic Review Reports (PRRs).
- Support and participate in self-inspection or other audits with particular reference to the analytical aspects of cGMPs as defined by the Health Authorities and Food and Drug Administration.
Requirements:
- BSc/MSc/PhD in Biochemistry, Molecular Biology, Cellular Biology, Biology or related field with minimum 7 years of recent experience preferably in a QC laboratory environment.
- Experience with molecular testing, such as ELISA assays, qPCR assays.
- Experience with separation testing, such as HPLC, UPLC, CE, iCIEF assays.
- Strong written and oral communication skills.
- Ability to work independently, self-sufficiently and pro-actively in the performance of work duties.
- Ability to resolve conflict, and promote good decision making among team members.
- High learning agility and flexibility to achieve the required outcomes.
- Imaginative approach to problem solving and solution discovery.
