Scientific Program Manager

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Scientific Program Manager
Job ID
2022-11414
# of Openings
1
Job Location(s)
US-MD-Gaithersburg
Posted Date
1 day ago
(1/19/2022 1:49 PM)
Category
Science, Research & Regulatory
Overview
We are currently searching for a Scientific Program Manager 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 Rockville, MD.
Duties & Responsibilities
Work with federal staff responsible for cGMP product development of vaccines for infectious diseases including the production of investigational products that are identified as strong candidates to move from a preclinical to clinical phase.
Plan, organize, and coordinate cGMP activities across all project stakeholders. Set deadlines, record responsibilities, and monitor and summarize progress of various cGMP manufacturing projects.
Participate as a team member in a group composed of different staffing areas including scientific/technical roles, project management, regulatory affairs, quality assurance, contracts, and finance. Activities include participating in both the development of vaccines and adjuvants, assisting in the authoring the Chemistry, Manufacturing and Controls and Toxicology sections of Investigational New Drug submissions, providing protocol and Investigator Brochure review, and assisting in providing oversight of Contract Manufacturing Organizations.
Coordinate with Quality, Regulatory, and Technical team members for health regulatory compliance.
Assist the team with impact/risk assessment from issues, failures and deviations during manufacturing and pre-clinical studies.
Develop, coordinate, and monitor business agreements to include MTAs, CRADAs, DTAs, and other agreements as necessary.
Prepare technical reports, updates, and summaries for internal meetings with Division Management.
Participate in site-visits of CMOs at kick-off or during critical project execution stages or for troubleshooting as requested by the POC.
Maintain an organized, efficient, and accessible electronic document filing system. This includes historical, current, and projected information on proposals, presentations, business agreements, grant awards, cGMP projects, and other Branch activities.
Review, GMP manufacturing batch records, SOPS, deviation reports, etc.
Participate with Team members to track product stability reports with respect to stability timepoints, review the product stability protocol for consistency and completeness, ensure that the stability program matches the requirement per the project Statement of Work, review stability Certificate of Analysis and/or Stability reports/data for out of specification testing results, issue the Shelf-Life Extension document after reviewing of the stability report.
Assist in the preparation and review of regulatory documents including pre-IND materials, and IND, as required.
Prepare oral and written presentations for internal and external programmatic and scientific meetings.
Participate in virtual and on-site audits of vendors.
Requirements
M.S. Degree in Biochemistry or Biology or equivalent and at least eight (8) years of experience in industry, or B.S. degree in biochemistry or biology or equivalent education and at least ten (10) years of experience in industry.
PMP certification and experience in managing cGMP of biologics/vaccines for phase I, IND studies is preferred.
Familiarity working in project execution and management of a scientific nature.
Experienced performing site visits and quality assurance inspections, and handling risk/assessment issues.
Ability to coordinate and monitor business agreements.
Ability to communicate effectively and to advise senior-level staff.
#LI-EJ1
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.
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 **** or via email at ****. 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.
Medical Science & Computing is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

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