Senior Scientist, Cell Culture Process Development

Location
Gaithersburg, Maryland
Posted
Dec 05, 2021
Ref
2021-10413
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

We are currently searching for a Senior Scientist, Cell Culture Process Development to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and is on-site in Gaithersburg, MD.

Duties & Responsibilities
  • Lead development of cell culture processes for clinical vaccine or therapeutic candidates and the process tech transfer to the VCMP for clinical grade material generation for the program
    • The vaccine candidates may include viral vaccines, recombinant proteins and/or virus-like particles, or monoclonal antibodies.
    • The cell culture processes may include process development and scale up of mammalian cell expression systems.
    • Planning, designing and overseeing the execution of experimentation leading to the development of a robust process amicable for toxicological grade material generation and scalable for efficient cGMP production at VCMP.
  • Serve as SME for tech transfer deliverables, regulatory submissions and project planning.
  • Draft and review technical documents such as process descriptions, batch records and support regulatory submissions.
  • Capture process descriptions and results in lab notebooks and other technical documents that may drive SOP generation, review, and approval.
  • Lead and train a team of associate scientists to develop processes requiring operation of bioreactors and other cell culture equipment.
  • Manage team and cell culture project schedules through coordination with project management, cell line development and downstream processing groups.
  • Participate in project and laboratory meetings, keep current with compliance obligations, and be responsible for maintenance of the laboratory and equipment.
  • Contribute results and studies for conferences and publication in peer reviewed journals.

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Requirements
  • Ph.D. in a Biochemistry, Chemical Engineering, or other life sciences with the following level of experience is preferred. M.S. degree with an additional four (4) years of industry experience will be considered. Additional requirements include:
  • Minimum five (5) years of experience with mammalian cell culture in an academic or industry setting.
  • At least two (2) years of experience with cell culture development for manufacturing processes, involving the following:
    • Established expertise with glass vessel and single use bioreactors systems.
    • Experience with AMBR (either 15 or 250) systems is a plus.
    • Experience with perfusion is desirable, but not required.
  • Demonstrated leadership capabilities through either team leadership roles or mentoring graduate or undergraduate students.
  • Demonstration of contributions to relevant fields through peer-reviewed journal publications.

Due to our contractual requirements and federal orders, including an Executive Order from the White House and an emergency regulation from the Centers for Medicare & Medicaid Services (CMS), the position for which you are applying requires that you provide proof of your vaccination status. If you are unable to receive the COVID-19 vaccine for medical reasons or because of a sincerely held religious belief, you may request an exemption from the vaccination requirement which shall be reviewed after the submission of requested documentation. If an accommodation is granted, the conditions may include weekly testing and masking. All Guidehouse employees also agree to follow any additional health and safety mitigation policies that may be required in the workplace.

Company Description

Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) were acquired in October 2021.

 

Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.

 

Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

 

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance, including the Fair Chance Ordinance of Los Angeles and San Francisco.

 

If you have visited our website for information about employment opportunities or to apply for a position, and you require accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at 

 

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse, and Guidehouse will not be obligated to pay a placement fee.