What are the responsibilities and job description for the Director, Platform Technology & Operations position at Piper Companies?
Piper Companies is looking for a Director, Platform Technology and Operations to join a large pharma biotechnology organization. This is a full-time position and onsite in Gaithersburg, MD.
Essential Duties of the Director, Platform Technology and Operations:
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Essential Duties of the Director, Platform Technology and Operations:
- Set standard for vison of platform, standards of engineering, and define a multi-year roadmap.
- Create engineering templates and playbooks for platform process descriptions, P&ID standards, utility requirements, and manufacturing technology standards.
- Set the design principles for facility interfaces (cleanroom and HVAC for example) that enable platform technologies.
- Set enterprise standards and adoption plans for end‑to‑end processing, including facility design requirements and utility infrastructure.
- Collaborate with CMC, Clinical, Regulatory, QA, Facilities Engineering, Project Engineering, and site leaders on process risk, equipment selection, facility design, and lifecycle strategies.
- Lead site technology transfers, facility‑fit assessments, utility definition, equipment installation and qualification protocols, and adoption of digital monitoring/decision tools.
- 10-13 years in biologics manufacturing
- Strong background in process engineering or facilities engineering
- B.S. or M.S. in Chemical Engineering, Mechanical Engineering, or related field
- 7 years in Process Engineering/Development with facility design exposure; late stage and commercial Pharma experience.
- Demonstrated experience in process scale up, equipment specification and selection, P&ID development, mass/energy balance calculations, and facility design for biologics manufacturing.
- Experience with cleanroom design, utility systems (WFI, clean steam, HVAC), material flow optimization, and equipment layout for GMP.
- $175,000 - $250,000 (based on experience)
- Comprehensive benefit package; Cigna Medical, Cigna Dental, Vision, 401k w/ ADP, PTO, paid holidays, Sick Leave as required by law, paid holidays
Keywords: 401k, 401k match, pto, paid time off, holiday, medical, dental, health, culture, science, biology, chemistry, biotechnology, biotech, biochem, biochemistry, upstream, downstream, manufacturing associate, upstream manufacturing, downstream manufacturing, allstream, all stream, allstream manufacturing, all stream manufacturing, aseptic, bioreactor, biosafety, cabinet operation, cell bank, cell banking, centrifugation, centrifuge, filtration, chromatography, cell culture, cell operations, osmolarity, protein concentration, ph, buffer, bioprocessing, cgmp, gmp, gcp, good manufacturing practice, good clinical practice, biopharma, biopharmaceutical, clinical, clinical development, current good manufacturing practice, regulatory requirements, manufacturing downstream, manufacturing upstream, manufacturing allstream, global technology, mechanical engineer, mechanical engineering, chemical engineering, chemical engineer, platform technology, roadmap, road map, cpp, equipment specifications, playbook, playbooks, P&ID, hvac, hvac requirements, material flow, equipment layout, equipment layouts, pat strategies, apc strategies, rtd model, facility readiness, manufacturing leadership, process leadership, platform strategy, technology strategy, cms, regulatory, facilities engineering, project engineering, facilities design, facility design, clean utilities, waste treatment, automation infrastructure, microbial, fermentation, biologics, biologics manufacturing, process development, n1, n 1, perfusion, process simulation, superpro, super pro, aspen,
Salary : $175,000 - $250,000