DynPort Vaccine Co LLC, a GDIT company, is seeking a Technical Development Manager. This individual will be responsible for overseeing and coordinating the technical development of DVCs recombinant vaccine, with the objective of achieving FDA licensure using the US FDAs Animal Rule. The project is funded through a U.S. government contract, so the Technical Development Manager will work with a program management team that has responsibility for the overall program cost, schedule and contract performance aspects.
DVC was selected as the 2017 Best Place to Work among large employers in Frederick County, Maryland (See http://www.discoverfrederickmd.com/news/frederick-county-best-places-to-work-honored). In receiving the award, it was recognized that DVC treats our staff with fairness, maintains a great business culture, and finds special ways to enhance the overall work experience. At DVC, performance—with work/life balance—is the norm.
The successful candidate becomes an important champion for this extraordinary company culture and will have the opportunity to make substantial contributions toward the development of vaccines and therapeutics that will protect civilians and dedicated Armed Forces men and women.
Typical Duties and Responsibilities:
Serves as the technical lead of a highly energetic, matrixed team comprising manufacturing, nonclinical, clinical and regulatory experts.
Translates the clients technical requirements into a technical development strategy, achieving a balance between technical considerations and, through the Program Manager, the risks and impact on program cost and schedule.
Responsible for effective problem-solving of technical issues and for accurate and timely communication to senior management and to clients.
Masters degree or equivalent combination of education and experience
Masters degree with 15 or more years job experience and degree in one or more of the following research areas: manufacturing, biotechnology, virology, immunology, chemistry, bacteriology, molecular biology, toxicology, medicine, nursing or related field
Ph.D with ten or more years of experience in conducting product development or research (manufacturing, analytical, nonclinical or clinical) experience in the biotechnology field
Current Good Manufacturing Practice (CGMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP) research experience developing biotechnology products or industry experience preferred
Ten or more years CGMP or GCP experience for manufacturing/analytical and clinical differentiators
Project management certification preferred
Five or more years project management experience with pharmaceutical company in manufacturing, clinical or nonclinical departments
Ability to work both independently and as a member of matrixed teams and working groups
Must demonstrate flexibility and an ability to manage strategy within a matrixed organization, clearly identifying and distinguishing need to know scientific objectives
Creative problem solving skills and an ability to apply those skills to development of a vaccine are essential
Minimum of five years of experience managing product development of a vaccine, with clearly defined goals and successful progress is essential. Late-stage product development experience and/or a background in manufacturing are highly preferred
Must demonstrate technical competence in a relevant scientific area, with preference given to candidates with a strong knowledge of Good Manufacturing Practice guidelines
Candidate must have demonstrated experience managing senior level scientists. Preference will be given to candidates with demonstrated experience managing doctoral level personnel
Candidate must have strong team-building and interpersonal skills as well as strong oral and written communication skills
Doctorate (PhD) preferred, with a minimum of ten years of experience beyond a postdoctoral fellowship
Must demonstrate strong technical training in manufacturing or validation of processes or assays
Specific knowledge of toxins, small molecules or Pichia expression systems is a plus
Ability to work independently and as part of a team
WHAT GDIT CAN OFFER YOU
Autonomy, career mobility, challenging work, and team environment
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
GDIT is an Equal Opportunity/Affirmative Action 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, or any other protected class.