This candidate is expected to provide strong hands on technical leadership, guidance and day to day supervision to a group of scientists responsible for providing analytical support for early phase vaccine programs. This individual will be responsible for the development of analytical methods for biomolecules and viruses, method qualification, assay transfer and in-process support. The candidate will contribute to the development of assay control strategies and resource prioritization.
- The individual is expected to manage a group of scientists within Analytical Development within Vaccine Research and Development, which has a focus on analytical assay development and analysis of various antigens (including viruses, proteins, and conjugates) used in vaccines under development. The expectation is that they will spend 30-40% of their time on the bench.
- This individual is expected to independently design, execute and/or direct development, qualification and transfer of assays for testing/characterization of vaccine samples in support of process and formulation development. Primary methodologies include separation-based techniques, mass spectrometry, and NMR.
- Collaborate as necessary with appropriate colleagues and leaders within Vaccines and across other departments to understand the nature and approaches of the assays to be developed, qualified and transferred.
- Plan and coordinate support resources to ensure the timely execution of the analysis of vaccine samples to support the process and formulation development, as well as the release, stability and characterization testing of vaccine candidates for pre-clinical development.
- Supervise assigned staff including setting objectives and performance management, Ensure that the staff has received appropriate training and that the training is current. Provide work assignments to direct reports on a regular basis. Manage and assist reporting scientists in the prioritization of method development and analysis efforts. Identify appropriate scientific meetings/training workshops for direct reports.
- Write and review technical documents to support assay development, qualification, and transfer.
- Closely work with management to define long term strategies for the group. Represent the Analytical and Formulation Development group in relevant project team meetings within Vaccine Research and Development.
- Keep abreast of scientific/ technological developments by participating in scientific meetings/ seminars and through regular scientific review. Present experimental results at group meetings, project meetings and department meetings. Participate in scientific discussion with colleagues through internal journal clubs, as well as informal and formal scientific seminars and meetings.
- Manage daily, weekly and monthly laboratory activities, such as monitoring of equipment, completion and review of equipment logbooks, periodic laboratory cleaning and managing the laboratory waste, checking PMO status of lab equipment and resolving discrepancies. Manage storage of reagents and test solutions in accordance with departmental procedures.
- Satisfactorily complete all GLP and safety training in conformance with departmental requirements. Where applicable, performs job responsibilities in compliance with GLP and all other regulatory agency requirements.
- PhD in Chemistry, Biochemistry, or related discipline with at least 4 years of pharmaceutical or biotechnology industry experience is necessary.
- Strong analytical skills are vital for this position.
- Strong leadership skills are required.
- Knowledge and skills in analytical and bioanalytical method development and characterization for biomolecules and viral-based entities using a range of analytical and bioassay techniques as well as sound understanding of ICH guidelines are a must.
- Experience working with vaccines, biopharmaceuticals, and viruses is desired.
- Planning and management of technical and strategic issues in support of assay development and qualification activities including providing guidance and support with respect to sample preparation, execution of analysis, and method development/ qualification.
- Knowledge and ability to assess new technology or methods for detection and quantitation of the target antigens for potential vaccines.
- Ability to write technical documents, including but not limited to method SOPs, development reports, qualificationreports, method transfer protocols and method transfer report.
- Ability to prioritize assay development/ qualification and transfer activities based on project priorities and timelines.
- Must receive and maintain required vaccinations or provide satisfactory proof of same.