Title: Technical Project Manager Location: Onsite, Boston, MA Type: Contract to Hire Hours: Standard business hours Overview: Join a US biotechnology site expanding in Boston for a federal initiative in RNA medicine manufacturing. Lead a next-generation platform in advanced manufacturing and quality control as the CTO's deputy. Oversee execution across technology workstreams and collaborate with industry partners. Manage a complex program from concept to demonstration and help shape the future of RNA manufacturing.
Responsibilities:
Own end-to-end delivery of the programme on behalf of the CTO and Principal Investigator, and act as his empowered deputy.
Build and own the integrated master schedule spanning the manufacturing system and the analytics system, including the cross-dependencies that determine the month 18 integration readiness gate and the month 24 full-system integration date.
Author and maintain the Project Plan Document; run the kickoff and the formal design reviews with the sponsor.
Run the deliverable workflow — approximately fifty contract deliverables across the first two phases — with a review and release gate before anything reaches the sponsor.
Manage subcontracts, teaming agreements, statements of work, milestone acceptance and invoicing across eleven partner organisations.
Own cost and schedule control: labour burn against budget, earned value, change control, and the risk register embedded in every engineering design package.
Represent the programme to sponsor programme managers and to independent verification and validation teams at every phase gate.
Requirements:
BS or MS in engineering, physical science or life science. Ideally in systems engineering. PhD in a related field is desirable. A project management certification is also desirable, ideally on Agile project management.
Eight to twelve years managing complex development programmes combining hardware and biology, the some track record on federally funded programmes as, or directly for, the prime contractor. Ideally on instrument development.
A demonstrable track record of taking a multi-subsystem instrument or automated production platform from architecture through fabrication, integration, verification and customer demonstration. Programmes that ended at design review do not count.
Conversant on FAR and 2 CFR 200 cost principles, subcontract management, milestone-based invoicing and federal reporting cadence.
Technical literacy sufficient to read a P&ID, a system block diagram and an interface control document, and to challenge an engineer's estimate credibly.
The autonomy to run the programme day to day and report to the Principal Investigator.
Desirable: Prior ARPA-H, BARDA or DARPA prime experience. RNA, LNP or cell and gene therapy exposure. INCOSE training. US person status preferred.
#M3 #LI-MD2 Ref: #558-Scientific
Numbers & Facts
Location
Boston, MA
Industry
Biotechnology/Pharmaceuticals
Company Size
500 to 999 employees
Website
https://www.jouleinc.com/
About Company
With extensive scientific, clinical, and healthcare industry experience, Joulé recruiters excel at placing talent across core specialty areas:
Scientific staffing for hard-to-find skills
Working across every scientific discipline, Joulé places biologists, chemists, scientists, technicians and other specialists.
Clinical lifecycle recruiting
From research to regulations, safety to statistics, Joulé helps clients manage every stage of the clinical development lifecycle.
Equipment calibration, maintenance and validation
Laboratory and facility support comes with a total quality commitment backed by ISO 9001:2008 certification.
National healthcare recruitment
Trust Joulé’s extensive experience in physician, advanced practice provider and executive direct placement search.
Skills
Agile Programming Methodologiesunmatched
Billingunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Budgetingunmatched
Cadenceunmatched
Change Controlunmatched
Code of Federal Regulationsunmatched
Consultingunmatched
Contract Managementunmatched
Cost Controlunmatched
Document Managementunmatched
Drug Manufacturingunmatched
Embedded Systemsunmatched
Gene Therapyunmatched
Literacyunmatched
MD2 (Message Digest Algorithm 2)unmatched
Manufacturingunmatched
Manufacturing Systemsunmatched
Physical Scienceunmatched
Production Scheduleunmatched
Project Management Certificationunmatched
Project Planningunmatched
Project/Program Managementunmatched
Quality Controlunmatched
Risk Managementunmatched
Statement of Work (SOW)unmatched
System Integration (SI)unmatched
Systems Analysisunmatched
Systems Engineeringunmatched
Technical Leadershipunmatched
Technical/Engineering Designunmatched
Validation Testingunmatched
Writing Skillsunmatched
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