Senior Scientist, Downstream Process Development
We are currently searching for a Senior Scientist, Downstream 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
- Develop downstream processes, with minimal supervision, for recombinant proteins such as monoclonal antibodies, subunit or nanoparticle vaccines, and virus-like particles (VLPs) that may be used as clinical therapeutic or vaccine candidates.
- Work independently and collaboratively within the purification group to design, develop and optimize chromatography, Tangential Flow Filtration (TFF), and Normal Flow Filtration (NFF) processes.
- Apply process optimization techniques, such as Design of Experiments (DoE) or other statistical design approaches.
- Purify research-phase recombinant proteins, virus vaccines and/or virus-like particles in support of other groups.
- Serve as a functional lead and/or Subject Matter Expert (SME) in an inter-department Chemistry, Manufacturing, and Control (CMC) team with responsibilities for the following processes: chromatography, depth filtration, nano-filtration, and tangential-flow filtration (TFF)
- Train associate scientists in the execution of chromatography and filtration processes.
- Support Viral Clearance Validation studies by traveling to CMO/CRO sites to perform and oversee viral clearance chromatography and filtrations processes.
- Work collaboratively with all departments to coordinate schedules, material needs, and other deliverables to advance site-wide project goals.
- Analyze and compile data, present at various group/department meetings.
- Represent the program at external conferences, workshops, and/or seminars.
- Write and review process batch records for toxicology batch productions.
- Write and review technology transfer documents in support of GMP manufacturing.
- Write and/or review appropriate CMC sections of IND filings (e.g Process Description Summaries) to support regulatory group.
- Ph.D. in Chemical Engineering, Biology, Chemistry, or related Life Sciences field.
- M.S. Degree with 6 years or more, relevant experience is also acceptable.
- Two (2) to ten (10) years of experience in industry-relevant recombinant protein process development for GMP clinical-phase products.
- Demonstrated knowledge of maintaining accurate and detailed records.
- Demonstrated expertise in the following techniques or tools for protein purification and characterization:
- Column chromatography for protein purification by means of AEX, CEX, affinity, SEC, HIC
- Column packing and testing
- AKTA chromatography system
- Lab scale TFF systems
- Lab scale nano-filtration systems
- Qualitative assays including SDS-PAGE and Western Blot
- UV/Vis spectrophotometer
- Must be a team player who can effectively work with members from cross-functional departments.
- Strong oral and written communication skills.
- Familiarity with computer software including word processing and data evaluation.
- Knowledge and use of statistical design of experiments (DoE).
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.