We are seeking a Senior Scientific Program Manager to support the National Institutes of Health's (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with groundbreaking research. Candidates will work at a prominent, diverse and vibrant NIAID worksite to directly support exciting ongoing research activities as a contractor team member. Accelerate your career and apply below to help us make a difference.
CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs.
Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.
Responsibilities
Provide regulatory expertise and strategies for investigational biologics including early development, production and pre-clinical in vivo studies for a successful IND submission or equivalent approach for trials planned outside the US.
Evaluate and propose appropriate toxicity studies and models for products intended to be studied as vaccines.
Prepare Chemistry, Manufacturing and Controls (CMC) and Non-clinical study sections for regulatory submissions by acting as the scientific writer from available source documents.
Communicate with the FDA for submissions/meeting requests.
Coordinate with Quality and Technical team members for cGMP regulatory compliance.
Provide regulatory advice and recommendations to the Project Lead for manufacturing projects and pre-clinical studies.
Support the development of VTRB Standard Operating Procedures (SOPs) and advise the Branch Chief if the processes are appropriate to adhere to the cGMP requirements. Stay current on training and understanding approved SOPs.
Assist with drafting regulatory documents and review manufacturing proposals and Quality Agreements from potential CMOs and Partners, as needed.
Provide Subject Matter Expertise to assigned projects in viral clearance studies, formulation, processes, analytical development and manufacturing of engineering and GMP batches of biologics, adjuvants, and diluents.
Review documents supporting developmental and manufacturing activities, including, viral clearance study protocol/reports, tox study protocols/reports, formulation/process/analytical method development reports, methods validation protocol/reports, specifications for DS and DP, deviations, manufacturing batch records, and release of GMP materials.
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.
Qualifications
Ph.D. degree and at least 10 years of experience is required.
Knowledge of U.S. FDA regulations and guidelines, ICH Guidelines, International Health Regulations and their application to biologics is required. Experience working at the U.S. FDA is preferred.
Regulatory Affairs Certification is preferred.
Please submit your resume online at www.CAMRIS.com . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.
CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability.
Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.
