Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop productsdesigned-to protect life.
I: Job Summary
The Sr. Scientist will be responsible for maintaining analytical methods and instruments in a compliant state throughout their lifecycle. The Sr. Scientist will support transfer of manufacturing processes and analytical methods for implementation at the Baltimore site. The activities include managing technology transfer information flow, assessing fit of the process in the plant, assisting in the acquisition of capital equipment and supplies for the production of biological drug supplies. The scientist will also lead set-up of contract testing and development of biological safety assays for new platforms. Additional activities include troubleshooting manufacturing processes in Baltimore in collaboration with Baltimore Manufacturing Operations, Manufacturing Development and the PAD groups at other sites. A main focus will be the optimization and troubleshooting of analytical methods implemented at the Baltimore Bayview site.
- Develop transfer protocols and reports.
- Assist in the design, development, execution, statistical analysis of validation protocols for analytical, bioanalytical, and compendial methods used for the analysis of product and process impurities.
- Develop and optimize methods to address facility or client needs.
- Conduct method optimization, verification, qualification and validation. This includes analyzing and interpreting data, writing protocols and reports, investigating analytical problems and developing approaches to rectify those problems.
- Review current laboratory practices to identify new and alternative strategies or cost saving measures for laboratory improvement.
- Provides scientific review of protocols, reports, study design and standard operating procedures.
- Demonstrate strong technical writing skills.
- Interact with other functions on a technical level for various projects including but not limited to Quality control and Manufacturing Sciences & Technology.
- Assist in the strategic planning and management of technology transfer for clinical and commercial material production at Bayview.
- Provide input to troubleshoot manufacturing complications in collaboration with Manufacturing Sciences & Technology, Operations, and the PAD groups at other sites.
- Maintain good working relationships with organizations that are transferring processes to Bayview.
- Participate in activities such as process and analytical technology transfer, statistical process control, process technical evaluations, process quality improvements (PAT), and site technologyinfrastructure.
- Compare manufacturing batches and evaluate process performance
- Develop documentation, i.e., test methods, user specs, SOPs and documents to support equipment/facility operation.
- Implement control systems to meet cGMP/GLP requirements where required including 21CFR Part 11 compliance
- Communicate, support, and meet corporate and site goals and objectives
- Prepare presentations for senior management to provide updates and facilitate decision-making.
- Build and maintain strong relationships with site leads, corporate management and staff to ensure effective communication.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: Education, Experience & Skills
- Bachelor’s degree in Microbiology, Virology, or closely related scientific discipline with at least 8years of relevant experience, MS with a minimum of 6 years of relevant experience, or Ph.D. with a minimum of 4 years of experience.
- Board knowledge and experience in analytical assays including immunological, bioanalytical and chemical test methods such as Western Blot, ELISA, qPCR, IEF, Viral and Cell-based assays, SDS-PAGE, , DNA sequencing, microbiological methods, Sterility testing, Endotoxin testing, HPLC with multiple modes of detection, CE, and UV and IR spectroscopy.
- Must have knowledge and hands on experience of establishment of a mammalian cell culture lab with a thorough understanding of the equipment and procedures used to start new cell lines, making cell banks and maintain cell lines.
- Must have experience with developing and maintaining cell based potency and analytical assays.
- Experience with viral detection, viral titration (i.e. TCID50, plauque forming), and flow cytometry.
- Advanced knowledge of cGMPs, safety and data integrity.
- Experience in executing phase appropriate method qualifications and validations.
- Experience in assay method development, optimization, validation, equipment validation, and analytical investigation for biotherapeutic and vaccine products.
- Ability to apply statistical analysis to QC monitoring and trending.