The primary purpose of this function is to provide sound scientific rationale and technical expertise in downstream manufacturing and formulation for the production and release of early phase candidate vaccines and biologics. The Sr. Scientist will provide technical expertise and direction on project teams, writing, compiling and reviewing documents, developing and evaluating new bioassays and process development approaches. In addition, this position requires, as needed, assisting the business development team with proposals for government and commercial clients. This position may require 10-15% hands on work that include guiding and oversee laboratory technicians.
The main responsibilities will include but not limited to follows:
• Serve as subject matter expert on project teams, providing specific expertise regarding preclinical development in one or more areas: process development, formulation, manufacturing, quality control and quality assurance/regulatory affairs (GLP and cGMP).
• Maintain scientific expertise in the preclinical development of biologics and vaccines used for the prevention and treatment of infectious diseases.
• Perform experiments using Chromatography, TFF systems, and industry standard Harvest methods scale.
• Interacts with other departments involved in process development and GMP manufacturing.
• Participate in technology transfer of processes to Manufacturing and from external clients, and from Translational Sciences to QC and/or Process Development to Manufacturing.
• Identify gaps in business processes relevant to preclinical development and mitigate these by revising documents, templates, etc.
• Assist business development team with preparation of business proposals for government or commercial opportunities, providing technical expertise to write relevant sections and define strategy.
• Advanced degree (Ph.D.) in a related scientific discipline (biology/biotechnology, microbiology, virology) with 10+ years of direct knowledge and a strong technical foundation in product development for human clinical use.
• Expertise in the preclinical development of biologics (vaccines and/or biotherapeutics) including process development, manufacturing, quality control and regulated activities (GLP and cGMP) obtained in the pharmaceutical and/or the biotech industry.
• Excellent and proven written and oral communications skills, interpersonal skills, analytical/problem solving skills, negotiation skills, cross-functional team leadership skills, financial management skills and goal setting/time management skills are required.
• Effective presentation and meeting skills within all levels of the organization and with external colleagues and collaborators
• Ability to influence and motivate others while maintaining a cohesive team environment.
• Candidate should possess keen attention to details; able to initiate and organize projects, multitask and have intermediate to advanced computer/PC skills in MS Office, Outlook, etc.
• Meet all the pre-employment physical requirements as required by our Occupational Health Consultants to include drug screen, and favorable reference and background checks.
• Ability to multi-task and thrive in complex environment. Able to oversee multiple projects. Strong results driven focus, high level of enthusiasm and energy.
Build Value-Based Relationships: Generating alliances internally and externally by continuously identifying and acting on those things that will create success for the organization and its constituents, researchers, health care professionals and communities.
Contribute to Team Success: Actively participating as a committed member of a team and working with other team members to help complete goals and deliverables.
Customer Focus: Making customers (external and internal) and their needs a primary focus of one’s actions; developing and sustaining productive relationships; creating and executing plans and solutions in collaboration with team members internally and externally.
Provide Feedback: Objectively observing, analyzing, and sharing perception of other people’s performance to help reinforce or redirect behavior to improve performance and results and providing feedback that is timely, specific, behavioral, balanced, and constructive.
Work Standards: Setting high standards of performance for self; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed.
Consult: Providing timely, specific information, guidance, and recommendations to help fellow staff members make informed committed decisions that will lead to sustainable impact.
Establish Collaborative Working Relationships: Developing and using collaborative relationships to accomplish work objectives; developing relationships with other individuals by listening, sharing ideas, and appreciating others’ efforts.
Successful completion of the projects noted in the success factors above requires cooperation with our staff team and partners. Quickly establish working relationships to complete projects as scheduled above.