BioPharma CMC & Quality Consulting for Hire
BioPharma CMC & Quality Consulting for Hire
"When your team is new
or numbers are few
I can wear many hats,
and I'll help you."
6Hats CONSULTING brings a multi-faceted skill set, with added strengths to direct CMC, oversee CDMOs and contract Labs, and to drive Knowledge management, Process Excellence, Risk management, and the Quality Unit. When problems arise, we're already on board leading problem solving efforts, collaborating among all levels of your organization internally, and externally across CDMOs, CROs, contract labs and more. We'll model scenarios in the Gantts, assess risks, and present proposals to the Board. We're your BioPharma CONSULTING jack-of-all-trades.
3 decades spanning R&D through Tech Transfer to Manufacturing, through Quality Management and Third Party Oversight to Shipping, plus Program, Alliance, and Risk Management. Worked at BioPharma companies small to big through product and business life cycles from startup to commercial to sale. We draw on that experience for right-sized solutions we deliver through stage gates of discovery, design, and deployment. Root Cause Analysis and Risk Management expertise; early Start-ups virtual Operations leadership: IT tools deployment, employee on-boarding, and website build.
We burn rocket fuel to launch your solutions! Our Right-First-Time approach means lower total cost of ownership keeping your solutions in orbit. We'll build these solutions in the near term while simultaneously scouting a trajectory for success in the long term. 6Hats CONSULTING can match the needs peculiar to Startups all the way to the sophisticated needs of Commercial operations in CMC; Quality; Program Management; and, provide additional services, too. And, we ensure right-sized solutions delivered through discovery, design, deployment stage-gates.
BioPharma CMC, Quality, & Program Management for StartUps to Commercial Ops
When your team is new
or numbers are few,
I can wear many hats,
and I'll help you."
Need to formalize early project plans? Need to scenario-model? Need multiple projects integrated with teams internal and external, and with the cash runway?
Need to expand your third party network? Need technical and/ or quality audits of your network?
Need your data brought together from multiple sources — and efficiently? Need to manage different levels of access in your SharePoint, Egnyte digital library? Have a grip on your risks?
Need to setup company email, domain, user accounts, and hardware? Need a new website, social media launched? Need help creating to maintaining pitch decks and reports for investors and your Board?
Need to scale up or scale out manufacturing process? Need to assess new manufacturing technology?
Need to solve product or process nonconformances, maybe a first-time Out of Specification result? Need to document changes in process and product, maybe for Tech Transfer? Need help selecting, auditing, managing a CRO for early studies?