Mr. Signa has more than 20 years of project management experience leading cross-functional project teams of various capacities within the biotech and pharmaceutical industry. This includes managing project teams for global clinical supply, drug substance and drug product tech transfers, device development and launch teams, packaging development teams, campaign readiness teams, PAI readiness teams, and QC method transfer teams. He is also well versed in creating comprehensive and detailed Microsoft Project timelines.
Mr. Signa’s project management experience is matched by an additional 15 years of experience and leadership in pharmaceutical manufacturing and working with CMOs. He has previously managed employees in all aspects of sterile manufacturing, including component prep, equipment prep, high-speed fill/finish operations, lyophilization, terminal sterilization, product inspection, and packaging and labeling of vials and pre-filled syringes. He has also provided onsite fill/finish, packaging, and labeling guidance at CROs and CMOs with a focus on compliance and quality to ensure that final release of packaged drug product aligns with cGMPs.
As a Principal Consultant I at LBG, Mr. Signa provides programmatic and project management support and works closely with clients and internal LBG staff to manage the successful planning and delivery of client product development projects and overall product development programs.
Before joining LBG, Mr. Signa served as Senior Program Management Consultant at Amgen, where he managed key transformation initiatives that were highly matrixed, complex, and challenging, yet were critical to the success of the company. Throughout his career, he has held positions at several pharma companies, including Genentech, Emergent BioSolutions, GlaxoSmithKline, and Pfizer, among others.
A proven biotech professional, Mr. Signa is an expert in U.S. and international pharmaceutical and biotech regulations and has trained pharmaceutical manufacturing staff on cGMPs, developed job-specific training guides for all areas of pharmaceutical drug manufacturing, and established and sustained company-wide awareness of GMP compliance. His proven history of profitable leadership is fueled by his passion for working with production and project teams to deliver on client and stakeholder expectations.
Mr. Signa holds an M.S. in Biological Sciences and a B.S. in Biological Sciences with a minor in Chemistry from Northern Illinois University. He also received a post-baccalaureate pre-med certificate from University of California, Berkley and completed two years of coursework toward his Doctorate of Medicine from Ross University School of Medicine. In addition, Mr. Signa received his Project Management Professional (PMP®) certification from the Project Management Institute (PMI).
