Scientific Program Manager
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 GMP 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.
- 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.
- Assist in the evaluation and propose appropriate toxicity studies and models for products intended to be studied as vaccines.
- Coordinate with Quality, Regulatory and Technical team members for health regulatory compliance.
- Provide regulatory advice and recommendations to the Project Lead for manufacturing projects and pre-clinical studies.
- Assist the team with impact/risk assessment from issues, failures and deviations during manufacturing and pre-clinical studies.
- Prepare technical reports, updates and summaries for internal meetings with Division Management.
- Perform site-visits of CMOs at kick-off or during critical project execution stages or for troubleshooting as requested by the POC.
- 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 on site audits of vendors.
Degree (BA, M.S. or Ph.D.) in Biology, Health Sciences or a related field.
Minimum of four (4) years of related background/experience in vaccines for infectious diseases.
Experience in FDA-regulatory aspects of IND filing preferred.
Experience in GMP product development of vaccines for infectious diseases, SOP development, and preparing regulatory documents, including pre-IND and IND materials.
Experience writing and editing scientific documents required.
Experience preparing technical reports and Excellent analytical, interpersonal, and communication skills required.
Medical Science & Computing (MSC), a Dovel company, is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
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 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.