Associate Scientist, Analytical Development

We are currently searching for an Associate Scientist, Analytical 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

• Work with an HPLC or mass spec subgroup within the program/lab.
• Contribute to the clinical development of a variety of vaccine candidates and therapeutic biomolecule drug candidates.
• Develop assays for virus vaccines, recombinant proteins and virus-like particles, and some monoclonal antibodies, that may be used as clinical vaccine candidates or therapeutic antibody treatment.
• Contribute to method development, optimization, qualification, and testing support.
• Work with Tech transfer, investigations, writing GLP/GMP documentation including procedure, designing protocol, technical reports, and IND enabling support for bio-separation assays and mass spec-based assays for cGMP product release and characterization.
• Develop assays for cGMP product characterization and release of clinical material.

Requirements

• Master's degree in Life Sciences or related discipline.
• Solid understanding of protein chemistry and protein characterization methods. Prior cGMP assay development experience in a pharmaceutical or biotech environment setting is required.
• Experience in analysis of protein expression and proteomics characterization is highly desirable.
• Experience with analytical equipment automation will be highly beneficial.
• A thorough understanding of protein analysis with experience in quantitative and qualitative protein analysis for assay development is required.
• Knowledge of the requirements and experience developing, qualifying and/or validating assays for cGMP products and managing method transfers between laboratories is required.
• Strong working knowledge and proficiency with protein characterization using chromatography and/or mass spectrometry.
• Experience with release assay development on HPLC/UPLC (Waters preferred).
• Experience with mass spec assays including intact mass analysis, peptide mapping, disulfide mapping, post-translation modifications include glycan structure analysis.
• Experience with quantitative assays such as, LC-MS and HPLC (RP, IEX, and SEC) as well as qualitative /quantitative electrophoresis assays including SDS-PAGE, IEF and Western Blot.
• Proven data presentation, troubleshooting, and problem-solving skills.
• Familiarity of vaccine / therapeutic protein development and regulatory requirements such as GLP/GMP practices.
• Ability to implement new methods and technologies, particularly in compliant environment.
• Understanding of experimental objectives and experimental design, including a successful track record of independently performing experiments and consistently preparing accurate and complete experimental records.
• Excellent organizational, oral and written communication skills, including a customer-focused attitude.
• Ability and desire to work comfortably in a fast-paced team setting, collaborate with other groups, and deliver results in line with project and team objectives.
• Must be a team player

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) was 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 RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

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.