Your Strategic Pilot
Bridging Science, Compliance, and Strategy to Chart a Course to Success
Anjin partners with biotech leaders to navigate complex challenges, create actionable execution plans, and keep initiatives on course until goals are achieved
We guide companies from vision to execution, helping leadership teams define where they are going, how they will get there, and how to overcome obstacles along the way.
In the 17th century, an anjin was the trusted navigator — the skilled pilot who steered ships safely through uncertain waters. At Anjin, we bring that same precision, foresight, and steady hand to your business journey. We partner with founders, executives, and boards to transform vision into actionable strategy, anticipate and mitigate risks, and maintain momentum all the way to your destination. Whether you are preparing for a market launch, navigating a regulatory pathway, or aligning your leadership team, we chart the course, guide the execution, and ensure you arrive with confidence.
>Partnering, licensing, and M&A due diligence
>Investor communications and fundraising support
>Strategic risk assessment and mitigation planning
>Business continuity and resilience planning
>Designing effective teams and defining core capabilities
>Process development and scale-up strategy
>Tech transfer planning and execution
>Manufacturing strategy>Analytical method development and validation
>Stability program design and management
>Supply chain quality oversight>CMC regulatory dossier authoring and/or review
>Process development and scale-up
>Tech transfer planning and execution
>Process characterization and validation
>Process troubleshooting
>Analytical support
>Operational excellence and efficiency
>Early-stage product development road mapping>Target product profile (TPP) creation
>Budget development
>Quality management systems (QMS) design and implementation
>Vendor qualification and auditing
>Data integrity assessments>Quality culture training
>Quality management system (QMS) audits
>GxP compliance audits and training
>Inspection readiness and mock audits
>Aseptic manufacturing>Botulinum neurotoxins
>Clean room and/or containment manufacturing facility design, construction, commissioning, qualification
>Containment strategies for BSL-2 and BSL-3 manufacturing environments
>Custom training programs
>LMS / eDMS / eQMS configuration
Our team
We help biopharma teams bring innovative therapies to patients by bridging science, compliance, and strategy. From early development through commercialization, our experts partner with companies to navigate complex CMC and Quality challenges while staying focused on the bigger picture—safe, sustainable growth.
Rebecca Kerns brings more than 20 years of biotechnology leadership experience across GMP-regulated manufacturing, quality, and operations. She has led organizations through rapid growth, regulatory inspections, and facility expansions, integrating scientific rigor with business strategy to drive sustainable success. Before founding Anjin Biopharma Solutions, Ms. Kerns served as Chief Operating Officer of Object Pharma and as Managing Director of United Vaccines, where she oversaw quality systems, CMC operations, and regulatory compliance for high-containment biologics manufacturing. Earlier in her career, she directed quality and compliance functions supporting U.S. and E.U. licensure of veterinary and human biologics. Ms. Kerns holds an MBA from Edgewood University and a B.S. in Medical Microbiology and Immunology from the University of Wisconsin–Madison. Her career reflects a commitment to scientific excellence, operational integrity, and advancing innovation in biologics manufacturing.
Dr. Michael Jarpe brings more than 30 years of biotechnology leadership experience spanning startups and global biopharma companies. He has led multidisciplinary teams across R&D, CMC, and product development, guiding programs from discovery through commercialization.Before founding Anjin Biopharma Solutions, Dr. Jarpe served as President and CEO of Object Pharma and was a co-founder and Executive Vice President at Bonti, where he helped develop a novel neurotoxin platform that culminated in the company’s $200 million acquisition by Allergan. Earlier, he held senior roles at Allergan and Eisai, overseeing biologics process development, manufacturing, and regulatory readiness for multiple therapeutic programs.Dr. Jarpe earned his Ph.D. from the University of Florida. His career reflects a deep commitment to scientific rigor, strategic execution, and translating innovation into clinical and commercial success.
News
October 23, 2025Anjin Biopharma Solutions Launches to Help Biopharma Companies Move from Concept to Commercialization
After decades leading biopharma organizations, we’ve seen firsthand how powerful it is when science, compliance, and strategy work in concert. That belief inspired the creation of Anjin Biopharma Solutions — a consulting firm built to help companies navigate the path from idea to impact with confidence and precision.
We provide strategic and technical support across Quality, Technical Operations, and Business Excellence. Our work helps teams design inspection-ready systems, strengthen compliance frameworks, and align execution with business goals.
Beyond traditional consulting, we offer fractional and interim leadership, giving companies access to in-house caliber expertise without expanding headcount. We bring cross-functional insight across Technical, Quality, and Business Operations, ensuring that decisions in one area support success across all.
Whether your organization needs strategic direction, system design, or embedded leadership, we bring both the big-picture vision and the day-to-day practicality needed to move programs forward.
We’re excited to begin this next chapter supporting the teams driving innovation in biologics and beyond.
Contact: info@anjinconsulting.com
Follow: LinkedIn – @Anjin-Biopharma-Solutions