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).
Due to our contractual requirements, to be eligible for this role, you must be fully vaccinated against COVID-19 at time of hire.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.
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