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GMP Scientist I

Contract-to-Hire

Medasource

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Position: GMP Scientist I

Location: Durham, NC (100% onsite)

Duration: 6 month contract-to-hire

Role Summary 

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. 

Responsibilities 

 Advise management on strategic direction and focus on technical programs.

 Demonstrate bioprocess innovation and capability to develop suitable 

bioprocesses. 

 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 

teams. 

 Facilitate team data review and discussion at group meetings and larger team 

settings. 

 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 

larger settings. 

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. 

Required Skills 

 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.

JO-2312-141648

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