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Senior Scientist, Cell Culture Development

Company: Medical Science & Computing (MSC), a Dovel company
Location: Gaithersburg
Posted on: November 22, 2021

Job Description:

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 human trials.
  • 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 parameters.
  • 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 successful campaigns.
  • 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 peerreviewed journals.
  • 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 desirable
    • 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 essential.
    • 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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