Job Description

BryceTech is currently looking for a Technical Consultant. This position will be supporting a high-visibility ASPR client managing over $12B in portfolio value with a variety of needs including support to the project team, acquisition program, and industry outreach efforts. The Defense Production Act and Emergency Response Authorities (DPA-ERA) Office administers Presidential authorities delegated to the Secretary of Health and Human Services to accelerate, expand, and preserve the supply of materials and services within the public health industrial base. HHS strategically leverages DPA enabling authorities and provisions to help design, build, and sustain long-term domestic capabilities and capacity to manufacture medical countermeasures for future public health threats, including chemical, biological, radiological, and nuclear (CBRN) threats, emerging infectious diseases (EID), and other public health emergencies. HHS also ensures the availability of medical countermeasures necessary to respond to public health threats.

This role will support the development and management of innovative government programs to expand the industrial base for public health sector medical technology.

The person in this role will:

• Provide scientific and technical insight in at least one of the following areas within both the healthcare and pharmaceutical industries: pharmaceuticals, biotechnology, biologics, vaccines, therapeutics, diagnostics, and emerging manufacturing technologies.

• Advise on regulatory and quality affairs pathways for successful review of planned and known ASPR procurements that require regulatory clearance through other agencies, such as the Food and Drug Administration (FDA).

• Advise on innovative and novel approaches to support successful development, manufacturing, licensure, and distribution of MCMs and other health resources necessary to prepare for, respond to, and recover from public health threats.

• Advise on critical programmatic and project level regulatory challenges.

• Facilitate engagement between HHS/ASPR and national organizations focused on the manufacturing of materials and supplies necessary to produce “health resources” deemed essential for national defense.

• Provide scientific and technical support on execution of industry project analyses to provide recommendations for development, optimization, and/or maintenance efforts for mission- specific or mission critical challenges/issues.

• Produce clear, concise written reports and oral briefs to effectively communicate objectives and approaches to non-technical audiences.

• Conduct other tasks as assigned in keeping with the scope of this TO.

Qualifications

• At least 8 years of relevant industry experience as mid or senior technical operations (i.e., manufacturing, quality, regulatory, etc.) positions in the pharmaceutical or healthcare industries preferred.
• An advanced or doctoral degree in biology, biotechnology, chemistry, or pharmacy with commensurate experience preferred.
• Relevant experience supporting the successful regulatory clearance of a drug, medical device and/or product, biologic, or therapeutic through the FDA is preferred.
• Possess extensive knowledge of FDA/ICH guidelines and requirements preferred.
• Be proficient with all MS Office products, Adobe Acrobat

Additional Information

BryceTech offers a full range of benefits, including competitive salary, a comprehensive health plan including dental and vision coverage, company-paid life & disability insurance policies, 401(k) plan with company match, and an educational reimbursement program.

All your information will be kept confidential according to EEO guidelines.