ATCC Senior Scientist - Microbiology & Formulation Development in Gaithersburg, Maryland
The Senior Scientist - Microbiology and Formulation Development, will be responsible for developing, executing and managing R&D programs to establish innovative technology platforms. The incumbent plans, executes and troubleshoots research activities and investigates the feasibility of applying a wide variety of scientific principles and concepts. The Senior Scientist will be expected to develop and identify new and improved technologies and reagents for stabilization of various biological modalities (large molecule, DNA/RNA, bacteria and virus). The position will have a strong emphasis on development of lyophilized formulations and executing unique methods required for development of robust, scalable and reproducible formulations and processes for biological modalities. The Senior Scientist will also write application notes, journal articles and invention disclosures, as needed, and may give talks, posters and webinars in support of marketing activities. The incumbent will work closely with cross-functional representatives on technology development and tech transfer to operations and will participate on or lead cross-functional teams. Performance will be evaluated with respect to the quality and rigor of project design and execution, adherence to timeline, productivity and contribution to team and organizational goals. The Senior Scientist may mentor/supervise staff and is expected to lead by example. The incumbent supports, complies with and enforce all ATCC corporate policies and procedures.
This position must work and think independently; duties of this position are to be completed under administrative guidance. Decision making is a component of this position, and decisions have an impact on the overall success of the R&D team. Functions are to be completed in a timely manner with acceptable quality.
Responsible for developing and identifying new and improved technologies and reagents for stabilization of various biological modalities (large molecule, DNA/RNA, bacteria and virus).
Development and transfer of robust, scalable and reproducible formulations and processes for stabilization of biological modalities.
Develop and perform analytical assays as needed to assess stability and integrity of product formulations in various formats under a wide variety of storage conditions.
Conduct small-scale lyophilization experiments and/or direct production-scale, and lead and/or advise on technical transfer and scale up.
Perform troubleshooting activities, as needed.
Develop robust SOPs for tech transfer of new and/or improved methods to Operations and support of projects through successful tech transfer.
Anticipate technical risks and develops mitigation strategies that ensure the projects are executed with full scientific rigor and deliver robust products and tech transfer protocols and processes that are on-time, on-budget and to specification.
Develop appropriate application data to support posters at scientific conferences, webinars, website content, IP filings and other needs, as appropriate. Write clear and concise reports and project summaries for management review.
Remain current with knowledge in relevant scientific fields and brings new product development ideas into the pipeline and monitors new product introduction of key competitors.
Explore technologies, approaches and intellectual properties that would improve products and product convenience, stability, productivity and margin.
Identify and establish working relationships with external Key Opinion Leaders (KOLs) to help determine voice of customer (VOC), drive product specifications and provide early product performance data.
Communicate clearly and in a timely manner, work independently, collaborate extensively and think critically.
May informally or formally mentor or supervise junior staff.
Manage activities efficiently and effectively to meet program timelines and performance requirements in alignment with team and corporate goals.
Embrace the ATCC Mission, directives and corporate goals.
Education and Experience:
Ph.D. in Pharmaceutical Sciences, Microbiology, Chemical Engineering, or related discipline with 5 – 8 years of relevant work experience.
A Bachelor’s degree in a life science field and 15 – 18 years of relevant experience OR
Master’s degree in a life science field and 13 – 16 years of relevant experience may be substituted for a Ph.D.
4 – 6 years of relevant hands-on experience in lyophilization development, stability testing, and assay development is required.
2 or more years’ experience in industry and/or product development is highly desired.
Experience with assay development and troubleshooting.
Experience troubleshooting degradation pathways for biological modalities.
Experience of mentoring and supervising staff is desired.
Experience in an ISO accredited, and matrixed organization is preferred.
Knowledge, Skills and Abilities:
Deep understanding of lyophilization technology, theoretical knowledge and hands-on experience to lead projects involving stabilization of biological modalities (bacterial, virus, recombinant protein, peptides, other biomolecules).
Proficient in DSC/mDSC, spectroscopy and Freeze-Drying Microscopy method for the characterization of the frozen and dry formulation.
Ability to develop stabilization cycles for various types of biological samples (bacterial, virus, recombinant protein, peptides, other biomolecules).
Identify formulations matrices that ensure the long-term stability of biological modalities in liquid and lyophilized conditions.
Ability to develop statistical plan for targeted analysis of research data with a view to satisfy desired quality/standard.
Demonstrated ability to think innovatively, creatively and strategically and to exercise sound scientific and business judgment.
Ability to efficiently multi-task and appropriately prioritize projects.
Strong problem-solving skills to identify, evaluate and correct potential problems early.
Self-starter, motivated and focused; ability to work independently and in a cross-functional team.
Able to prepare technical reports, project progress reports, PowerPoint presentations and other documentation.
Adaptable and coachable; be able to shift priorities and focus as departmental and/or business demands change including, but not limited to early/late hours and/or weekend hours.
Follow all ATCC safety practices, Standard Operating Procedures (SOP’s) and policies.
Founded in 1925, ATCC is a non-profit organization with a mission to acquire, authenticate, preserve, develop, standardize, and distribute biological materials and information for the advancement and application of scientific knowledge.
ATCC is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.