ECS is seeking a
Technical SETA (Pharma) to work in our
Arlington, VA office.
Please Note: This position is contingent upon additional funding.ECS is seeking an exceptional candidate with a strong pharmaceutical regulatory background to join the Equip-A-Pharma program to support the Biological Technologies Office (BTO) at DARPA. The candidate should be an innovative thinker who can apply novel regulatory techniques to cutting-edge and complex pharmaceutical manufacturing problems, supporting the Equip-A-Pharma program Manager (PM) in pushing the boundaries of what's possible at the intersection of regulatory science and agile and modular pharmaceutical manufacturing technology. The program supports point-of-need manufacturing, addressing public health emergencies, and enabling a resilient pharmaceutical supply chain.
As a Regulatory Affairs specialist for Agile Manufacturing, and a member of the Equip-A-Pharma program Team you'll be the dedicated partner to your PM, supporting their revolutionary concepts. Your expertise will be key in navigating advanced regulatory frameworks to streamline agile pharmaceutical manufacturing and accelerate drug approvals. You'll work hand-in-hand with the PM, providing technical insights and contributing directly to the development and refinement of their ideas. You'll also collaborate closely with existing subject matter experts (SMEs) to ensure the seamless execution and success of the projects.
Specific Roles Include:
- Support the PM in their ideation loops:
- Provide specialized regulatory expertise and insights to help shape and refine concepts for agile pharmaceutical manufacturing and rapid drug approval processes.
- Constant collaboration:
- Maintain active communication with PMs, ASPR/IBMSC counterparts, and cross-functional teams to foster efficient project execution and knowledge sharing.
- Proactive analytical assessments:
- Conduct independent research and analysis of emerging regulatory trends, drug development advancements, and agile manufacturing technologies.
- Evaluate the potential impact of these developments on the Equip-A-Pharma program and proactively share insights with PMs to inform decision-making.
- Targeted research and analysis:
- Stay at the forefront of regulatory landscape changes, drug development breakthroughs, and agile pharmaceutical manufacturing technologies.
- Provide expert guidance:
- Offer strategic regulatory and scientific insights to PMs, ASPR/IBMSC teams, and internal stakeholders to empower them to make informed decisions.
- Expert communication and collaboration:
- Clearly and effectively communicate complex regulatory concepts and scientific information to diverse audiences, fostering understanding and facilitating collaboration.
- Overall, your focus will be on:
- Contributing your regulatory expertise to help develop and refine innovative concepts for agile pharmaceutical manufacturing and rapid drug approval.
- Proactively identifying and evaluating emerging trends and technologies.
- Empowering the PM and teams with the knowledge they need to make informed decisions.
- Driving the Equip-A-Pharma program towards its goal of revolutionizing pharmaceutical manufacturing and regulatory processes.
- Advanced degree (Ph.D. preferred) in Regulatory Affairs, Pharmaceutical Sciences, or a related field. Candidates with strong regulatory backgrounds and demonstrated interest in agile pharmaceutical manufacturing are encouraged to apply.
- Specifically, experience with regulatory approval processes, quality control, and compliance in the pharmaceutical industry.
- Extensive experience in developing and implementing regulatory frameworks for pharmaceutical products.
- Strong understanding of current Good Manufacturing Practices (cGMP) and regulatory requirements for drug approval.
- Demonstrated ability to navigate complex regulatory environments and develop innovative solutions for regulatory challenges.
- Familiarity with current trends and emerging technologies in pharmaceutical manufacturing, and the vision to see how these could be applied to agile manufacturing.
- Experience with large-scale data analysis and the ability to work with diverse data types, including but not limited to manufacturing process data.
- Proven analytical and problem-solving skills, with the ability to adapt regulatory approaches to novel manufacturing processes.
- Publications or patents in regulatory affairs, pharmaceutical sciences, or their applications to agile manufacturing are highly desirable.
- Ability to obtain clearance up to TS/SCI.
- Ability to work a significant portion of your support onsite in Arlington, VA