Goldbelt Professional Services
Process Advisor V
Goldbelt Professional Services - Frederick, Maryland, United States, 21701
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Overview
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Overview
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Process Advisor V
role at
Goldbelt Professional Services
1 week ago Be among the first 25 applicants
Join to apply for the
Process Advisor V
role at
Goldbelt Professional Services
Overview Goldbelt Professional Services specializes in providing expert resources for Public Health missions including scientific, technical, and administrative support from junior staff to high-level subject matter experts. Research and data driven, Goldbelt Professional Services’ experts create solutions customized to the client’s needs.
Summary:
The Process Advisor V shall support the CTO Program Office, acting as the CTO's representative on IPTs and meetings, managing Taskers, reviewing documents, summarizing publications and data, and other technical duties. The position requires a solid understanding of the literature and the ability to debate highly technical issues with other contractors. This role is specific to the JPM CBRN Task Order 3 contract in the CTO Program Office.
Responsibilities
Assist with outreach activities, organize visits, prepare agendas, document meetings, and follow up on action items.
Provide scientific/technology advice, technical oversight, and project management support in science and technology areas relevant to CBRN medical countermeasures.
Possess expertise in program management, product development, acquisition strategies, and contract guidance.
Familiarity with biologics cGMP practices and FDA requirements for drug development and licensure.
Guide product development strategies, establish links between clinical and non-clinical efficacy, and develop manufacturing strategies.
Provide technical opinions, collaborate on technical evaluations, and contribute to data analysis and publications.
Develop research project proposals, prepare updates, and assess schedule risks.
Review and develop technical documentation, including protocols, reports, and regulatory submissions.
Summarize technical results for various audiences, maintain knowledge of new technologies, and organize seminars for technology review.
Search scientific literature to support product development efforts.
Qualifications
5+ years of experience with Microsoft Office Suite.
Strong interpersonal and communication skills.
PhD in relevant fields with extensive experience, or a Masters with more industry experience.
Minimum 5 years of manufacturing experience.
Secret clearance required.
Preferred Qualifications:
Over 10 years of industry experience in pharmaceutical/biotech development.
Experience with FDA processes and DoD acquisition requirements for biodefense medical products.
Pay and Benefits
The salary range is $150,000 to $175,000 annually. Benefits include medical, dental, vision, 401(k), paid time off, and professional development.
Senior level Mid-Senior level
Employment type Full-time
Job function Management and Manufacturing
Industries Government Administration
#J-18808-Ljbffr
Process Advisor V
role at
Goldbelt Professional Services
1 week ago Be among the first 25 applicants
Join to apply for the
Process Advisor V
role at
Goldbelt Professional Services
Overview Goldbelt Professional Services specializes in providing expert resources for Public Health missions including scientific, technical, and administrative support from junior staff to high-level subject matter experts. Research and data driven, Goldbelt Professional Services’ experts create solutions customized to the client’s needs.
Summary:
The Process Advisor V shall support the CTO Program Office, acting as the CTO's representative on IPTs and meetings, managing Taskers, reviewing documents, summarizing publications and data, and other technical duties. The position requires a solid understanding of the literature and the ability to debate highly technical issues with other contractors. This role is specific to the JPM CBRN Task Order 3 contract in the CTO Program Office.
Responsibilities
Assist with outreach activities, organize visits, prepare agendas, document meetings, and follow up on action items.
Provide scientific/technology advice, technical oversight, and project management support in science and technology areas relevant to CBRN medical countermeasures.
Possess expertise in program management, product development, acquisition strategies, and contract guidance.
Familiarity with biologics cGMP practices and FDA requirements for drug development and licensure.
Guide product development strategies, establish links between clinical and non-clinical efficacy, and develop manufacturing strategies.
Provide technical opinions, collaborate on technical evaluations, and contribute to data analysis and publications.
Develop research project proposals, prepare updates, and assess schedule risks.
Review and develop technical documentation, including protocols, reports, and regulatory submissions.
Summarize technical results for various audiences, maintain knowledge of new technologies, and organize seminars for technology review.
Search scientific literature to support product development efforts.
Qualifications
5+ years of experience with Microsoft Office Suite.
Strong interpersonal and communication skills.
PhD in relevant fields with extensive experience, or a Masters with more industry experience.
Minimum 5 years of manufacturing experience.
Secret clearance required.
Preferred Qualifications:
Over 10 years of industry experience in pharmaceutical/biotech development.
Experience with FDA processes and DoD acquisition requirements for biodefense medical products.
Pay and Benefits
The salary range is $150,000 to $175,000 annually. Benefits include medical, dental, vision, 401(k), paid time off, and professional development.
Senior level Mid-Senior level
Employment type Full-time
Job function Management and Manufacturing
Industries Government Administration
#J-18808-Ljbffr