Scientist

Protecting Our Tomorrow
At Bavarian Nordic, we aspire to save and improve lives by developing innovative vaccines that are designed to unlock the power of the immune system. We are a global leader in smallpox/mpox vaccines, and our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, typhoid fever, and cholera. We excel in R&D innovation, manufacturing, and commercialization. We aim to improve health and quality of life for children and adults around the world – protecting our tomorrow. We hope that you will share this mission with us.

Scientist
The product Development team at Bavarian Nordic, San Diego, CA is seeking a Scientist to join our department. The successful candidate will be expected to work as part of a team that is focused on the vaccine drug product development from formulation to packaging for biological injectables and solid dosage to support different development phases from preclinical through late phase, commercialization, and product lifecycle management. The successful candidate will be able to work in a fast-paced team environment and be able to learn new skills quickly and support multiple development projects. The candidate

at Bavarian Nordic will be a key member of the Product Development team and will report to the Sr. Manager of Product Development.

Core Responsibilities

• Collaborate effectively within a team setting to lead the design, execution, and documentation of experimental studies for formulation development and process optimization
• Develop methods to characterize and understand the pharmaceutical properties of drug substances and formulations
• Develop and perform the screening and selection of formulation excipients, adjuvants using Design of Experiment (DoE) for formulation development for biological drug candidates. Serve as the primary liaison to vendors and collaboration parties for procurement and scientific evaluation of key analytical instruments and process equipment, managing purchases and coordinating material shipments
• Hands on contribution on lab experiments for different development projects
• Draft comprehensive development reports, memos, and other scientific documentation throughout the development process
• Contribute to regulatory submissions by authoring and reviewing documents, ensuring compliance and scientific integrity
• Engage in cross-functional collaboration with project management, quality assurance, analytical, Manufacturing Science and Technology (MSAT), and regulatory teams to facilitate development work and support manufacturing campaigns
• Provide robust technical support for process tech transfer, including serving as a person-in-plant (PiP) during manufacturing campaigns
• Organize and manage experiment timelines and assignments within the team, mentoring associates to complete lab studies efficiently
• Act as the key technical and scientific lead in the PD team for the development of new characterization assays, writing protocols, and managing troubleshooting processes
• Communicate development progress, timelines, and study results to upper management, ensuring transparency and alignment with project goals

Key Qualifications

• In-depth understanding of bio-chemical and physical properties of therapeutic biologicals including but not limited to proteins, virus-like particles, and bacteria. Have basic knowledge of protein quantification and characterization methods
• In-depth understanding of principles of bioanalytical characterizations methods including but not limited to: HPLC, SEC, DLS, intrinsic fluorescence, ELISA, DSC, SDS, western blot
• Strong ability of design, develop, and perform experiments with strong scientific rationale. Experience with Design of Experiment (DoE) is a plus
• Understanding of basic cycles of Lyophilization of biologics drug substances in industry and the critical parameters to control the yield and stability. Experience in developing a lyophilization cycle is a plus
• Understanding of basics of biological drug formulation and aseptic process for fill-finish
• Understanding of basics of GMP compliance for biological drug manufacturing
• Experience in CMO tech transfer and person-in-plant support is a plus
• Experience in scaling up for the formulation process and fill finish is a plus
• Mammalian cell culture, bacterial culture, and cell-based assay experience is a plus
• Proficient in writing detailed scientific reports and summarizing data for presentations and regulatory submissions
• Strong organizational and technical problem-solving abilities
• Experience supporting pharmaceutical product development and transfers to clinical manufacturing is a plus
• Ability to effectively prioritize tasks and manage multiple projects
• Act as a team player and collaborator who can listen effectively and communicate in an open, clear, and timely manner

Skills & Requirements

• 1-5 years of experience in the pharmaceutical formulation, process development, or drug product development field
• PhD in chemistry, biochemistry, pharmaceutical sciences, or a related field.
• 3-5 years of experience without a PhD
• Excellent written and verbal communication skills required.
• Record of successful publication is a plus
• 5-10% travel expected

We Offer
A chance to work in an international company with unique technology and a dedicated workforce. We welcome people who share our passion with a willingness to make a difference. We offer a dynamic and flexible work environment and an opportunity to develop both your personal and academic competencies. We offer a comprehensive benefits plan and a competitive compensation package.

Salary Range - $90k - $135k

Location: San Diego, CA – Onsite

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Caught your interest?
If you are interested in the position, we look forward to receiving your application via our recruitment system. Just click the Apply-Button on the right side of the page and you will be redirected to our application form.

Department:
Durham, NC, US, Durham

Lokation: USA

Application deadline: 06 May 2024