Position: GMP Scientist I
Location: Durham, NC (100% onsite)
Duration: 6 month contract-to-hire
The GMP, Scientist I will contribute to the development, tech transfer, and GMP
execution of production processes for innovative vaccine products. This position will be
involved in bioprocess development and GMP production, including lab scale process
development; scale up and tech transfer of the process into the GMP suite, and
execution of the process under GMP compliant conditions.
Advise management on strategic direction and focus on technical programs.
Demonstrate bioprocess innovation and capability to develop suitable
Use experience in leverage risk assessment to foster understanding and
comprehensive collaborative decision making.
Use knowledge of end-to-end process for manufacturing, experience working in a
CDMO environment, supply chain awareness, technology transfer, authoring
draft manufacturing batch records, bill of materials, process flow diagrams,
process description documents and collaboration with GMP manufacturing
Facilitate team data review and discussion at group meetings and larger team
Collaborate with other development teams to provide support for activities and
work diligently with cell line development and analytical development functions to
understand how the process impacts product quality.
Lead writing and review of technical development reports and protocols for tech
transfer and SOPs for GMP production, and present data to project teams and
Education and Experience
Bachelor’s degree in science, engineering, or related field. An advanced degree
(Master’s, PhD) is preferred. Plus 6 years relevant experience in the biopharmaceutical
industry or equivalent.
Demonstrated bioprocess innovation.
Expertise in CHO and mammalian cell culture, suspension bioreactor platforms,
process scaling up 3-40-200 L, single use technologies including ambr15 and
ambr250, media development, cell line development, cell culture harvest
clarification using depth filtration and continuous flow centrifugation and host cell
protein reduction during cell culture.
Experience with phase-I process development, DOE studies, development of
process control strategies. Familiarity with JMP or similar statistical software.
Demonstrated advanced ability to collaboratively solve complex problems aligned
with strategic program goals.
Superior oral and written communication skills.
Medasource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.