Senior Scientist, Cell Culture Development
Company: Medical Science & Computing (MSC), a Dovel company
Posted on: November 22, 2021
We are currently searching for a Senior Scientist, Cell Culture
Development to provide support to the National Institutes of Health
(NIH). This opportunity is a full-time position with MSC, and it is
on-site in Gaithersburg, MD. Duties & Responsibilities
- Provide technical oversight of cell culture (upstream) process
development projects for clinical candidates and manage tech
transfer efforts for clinical manufacturing to support first-in
- Collaborate with Lead scientists and/or associates to develop
upstream process methods that will enable robust and scalable
manufacturing of recombinant vaccine and therapeutic mAb biologics
at 200 to 2000 L scale productions.
- Design and collaborate with the execution of studies to support
cell culture process development, including process optimization
studies using statistical methods (e.g. Design of Experiments -
DoE) and provide supporting analysis to establish process
- Provide scientific direction in the set-up and execution of
fed-batch bioreactor cell culture operation of CHO and HEK293 cell
lines utilizing glass and single-use vessels.
- Work closely with Project Managers to ensure upstream
milestones are appropriately set and met on time.
- Effectively communicate with other departments on program
deliverables, material transfers, and overall project milestones in
advancing clinical candidates to manufacturing.
- Serve as a subject matter expert (SME) on cell culture
operations, including process optimization and scale up of CHO and
HEK293 cell lines in development, manufacturing, regulatory (CMC)
meetings, and external collaborations.
- Works with scientist and/or associates in troubleshooting and
improving upstream methods during the development cycle.
- Mentor and guide upstream personnel to maximize team
capabilities and advance individual performance along with program
goals. Works with individuals to expands skills and foster growth
in areas of improvement.
- Responsible for planning and overseeing the upstream processes
for toxicology lot material production. This includes
editing/approving all process protocols, managing execution
thereof, and the generation of production reports following
- Writes/edits/reviews tech transfer documents (Process
Descriptions/Process Flow Diagrams) to support upstream process
Master Batch Record authoring.
- Work with regulatory team as needed to support IND submissions
and other requests.
- Encourages and drives innovation to meet new cell culture
challenges and seeks to publicly distribute novel technologies
through presentations at conferences and/or publication in
- Collaborate with Manufacturing teams on Manufacturing Sciences
and Technology (MS&T) initiatives, as needed. Requirements
- PhD degree in Chemistry, Biology, Biochemistry Life Sciences or
a related discipline.
- Minimum ten (10) years of experience in mammalian (CHO and
HEK293) and/or microbial cell culture development with expertise in
scalable fed-batch processes.
- Expertise with Applikon Control systems is essential
- Experience with AMBR15 and/or AMBR250 systems is highly
- Demonstrated leadership capabilities are essential via team
leadership and/or project management experience
- Demonstration of contributions to relevant fields through
peer-reviewed journal publications
- Must be a team player who can effectively work with members
from cross-functional departments.
- Strong oral and written communication skills.
- Expert knowledge of Excel and/or other database systems is
- Knowledge and use of statistical design of experiments (DoE),
experience with JMP is highly desirable. 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. #LI-EJ1 Company Description We are a
trusted government partner that blends deep domain expertise with
advanced technologies to help our customers solve complex problems
that improve, protect, and save lives. As a rapidly growing
company, we combine entrepreneurial spirit, customer focus, and an
outcomes-based approach to support agency missions in health IT,
life sciences, public safety, and grants management. The Dovel
Family of Companies offers employees an opportunity to advance
beyond a specific role or contract, we offer a path to develop an
enriching career. We believe in empowering a culture of innovation,
customer success, and employee growth. What you'll get---
- Time Off! Flexible schedules and company paid holidays allow
you to take the time you need.
- Investment in YOU! 401(K) company contributions are yours to
keep with no waiting period.
- Choices! Unique healthcare plans to choose from with options
like fertility and orthodontia benefits.
- Discovery! With our tuition assistance and training programs,
we support your career advancement.
- Tax Savings! Enroll in pre-tax Health or Dependent Care
Flexible Spending, HSA with company contributions, parking, and/or
transit commuter benefits.
- Support! Working parents and busy professionals - we've got you
covered with a supportive culture, confidential Employee Assistance
Program and a membership to Care.com.
- Perks! Employee discounts, peer recognition programs,
company-wide wellness challenges, and fun community events.
- A Voice! A unique culture where you can influence decisions and
have your voice heard. We are an Equal Opportunity Employer with a
commitment to diversity. All individuals, regardless of personal
characteristics, are encouraged to apply. All qualified applicants
will receive consideration for employment without regard to race,
color, religion, gender, sexual orientation, gender identity,
disability, or veteran status.
Keywords: Medical Science & Computing (MSC), a Dovel company, Washington DC , Senior Scientist, Cell Culture Development, Other , Gaithersburg, DC
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