OverviewMake a direct impact bringing lifesaving therapies from partner sites to GMP manufacturing. As a Manufacturing Specialist - Tech Transfer, you will lead and execute end-to-end drug substance tech transfers from external partners/CMOs into our site, coordinating cross-functional activities, ensuring process and documentation readiness, supporting scale-up and validation (PPQ), and enabling efficient, compliant start-up of commercial or clinical production.
External USWhat you'll do
- Tech transfer planning and execution
- Translate process knowledge into site-ready procedures, batch records, and control strategies.
- Help design and review equipment/line fit, scale-up parameters, sampling plans, and process acceptance criteria.
- Coordinate cross-functional activities to drive right-first-time transfer and start-up.
- Process readiness and documentation
- Review and assess manufacturing documentation, training materials, and readiness packages.
- Ensure manufacturing instructions, bill of materials, and operational controls are accurate and effective for floor execution.
- Validation and control strategy
- Support PPQ strategy, protocol development, execution, and reporting.
- Partner with MSAT/PD to define CPPs/CMAs, control limits, and in-process control (IPC) strategy aligned to the control strategy.
- Deviation/CAPA and change management
- Assist in investigations for engineering, qualification, and tech transfer batches; contribute to root cause and CAPA development.
- Implement and manage changes through formal change control, ensuring alignment to filings and site procedures.
- Cross-functional leadership
- Serve as the primary interface among Manufacturing, MSAT/PD, QA, QC, Validation, Supply Chain, EHS, and external partners/CMOs.
- Lead/participate in tech transfer meetings, stage-gate reviews, and provide status reports to leadership.
- Compliance and inspection readiness
- Ensure activities align with cGMPs, site procedures, and regulatory filings (CMC).
- Support audits/inspections and provide SME coverage on transferred processes and control strategy.
- Shop-floor support
- Provide on-the-floor coverage during engineering, qualification, and PPQ runs; coach operators/technicians.
- Troubleshoot process issues, driving timely resolution and documentation.
- Continuous improvement
- Identify opportunities to streamline transfer workflows, documentation, and training to accelerate readiness while maintaining compliance.
Minimum education and experience requirements Candidates must meet one of the following:
- High School Diploma/GED and 10 years of related experience, OR
- Associate's degree, preferably in life sciences or engineering, with 8 years of direct experience, OR
- Bachelor's degree, preferably in life sciences or engineering, with 6 years of direct experience, OR
- Equivalent Military experience/training
And
- Strong cGMP manufacturing operations experience
- Understanding of operations sequence and cadence of activities
- Prior experience in updating and creating manufacturing documents per schedule
Preferred experience
- Biologics (mAbs, viral vectors, vaccines) and/or sterile fill-finish/aseptic processing experience
- Single-use technologies, cell culture, and chromatography/UFDF
- Familiarity with MES/EBR, LIMS, and equipment automation (e.g., SCADA/DeltaV)
- External manufacturing/CMO tech transfer experience
Core competencies
- Technical depth with practical, hands-on problem-solving
- Structured project management and prioritization under time pressure
- Stakeholder management and clear, concise communication
- Ownership, accountability, and a safety-first mindset
Work conditions
- On-site role with frequent shop-floor presence; some off-shift/weekend support during campaigns
- Physical requirements: Ability to work in cleanroom/controlled environments, gowning, and lift up to [5] lbs as needed
Why this role
- Drive visible results by transferring and launching critical therapies safely and compliantly
- Collaborate across Manufacturing, MSAT/PD, QA/QC, Validation, Supply Chain, and external partners
- Grow your technical and leadership skills in a high-impact, GMP environment
