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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 is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

Benefits & Perks:

Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

Pay Disclaimer:

The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.

JO-2312-141648

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