Introducing the CMKC Advisory Board!

I enjoy connecting with new individuals, embracing fresh experiences, and exchanging stories. I do believe engaging in meaningful communication, sharing insights, and respecting diverse perspectives enriches life. Besides, embracing challenges with our accumulated wisdom and experiences signifies true success. I possess a genuine penchant for observation. So far, I've absorbed considerable knowledge in protein purification and analytics and remain eager to continue learning through engagement and contribution across various work platforms, driven by dedication, strategizing, and dialogue. I anticipate that CMKC will unveil numerous new opportunities as it marks the beginning of a fresh chapter in my life.

Over the past nine years, I have dedicated my career to solid dosage manufacturing where I have been involved in process development, process analytical technology (PAT), real-time release testing (RTRt), control strategy, validation, and commercialization of direct compression processes.

Joining the Continuous Manufacturing Knowledge Center (CMKC) Advisory Board is an exciting opportunity for me and aligns with my background in continuous manufacturing. The CMKC is committed to promoting collaboration between industry and academia allowing knowledge from both sources to be consolidated and widely available to all. Looking back, the CMKC would have greatly benefited me during my early years in the industry by offering a platform to seek answers and engage in insightful discussions with fellow professionals. For this reason, I am looking forward to the opportunity to contribute to this platform and engage with the community.

I immediately connected to the mission of CMKC and goal to create the world “where all have access to safe, quality medicines, and trusted diagnostics”. I am thrilled to join the advisory board and others driven by the same mission, vision and goals. This role allows me to continue build the online platform, engage and empower others to further advance their knowledge, share ideas, ask questions and by doing so advance the local and global health impact of USP.

I spent 16 years in life sciences, diagnostics, and healthcare where I built and led cross-functional teams to develop and launch commercial products in various industries proteomics, oncology, infectious diseases to name a few. I have experience in scaling business, commercializing early-stage technologies, and serving as an advisor, consultant and a thought partner to various leadership teams.

I enjoy exploring the beautiful outdoors by skiing, biking and hiking.

I am very pleased to have been selected to join CMKC in an advisory role to guide, coordinate and promote the exchange of challenges, ideas, experiences and solutions to built  a dynamic repository of  best practices for pharmaceutical continuous manufacturing.   With the help and cooperation of our colleagues worldwide, we have the opportunity to create a center of knowledge of great impact to our industry.

I have over thirty years of experience in a broad spectrum of the activities involved in drug development, manufacturing and packaging; from both technical as well as managerial/financial perspectives.  I believe very strongly in innovation and improvements to products, practices and processes to produce high quality products at a competitive cost. 

I am looking forward to engaging with professionals from varying backgrounds and experiences to build a dynamic archive of useful information that supports the mission  and vision of the CMKC.

I’m very delighted to join CMKC in an advisory role to facilitate discussions, sharing knowledge, challenges, experiences, and solution within the pharmaceutical continuous manufacturing community. I’m looking forward to engage with professional colleagues from different areas of pharma industry to exchange ideas, share useful information, and co-create the Knowledge Center content and tools.

I have over twenty years of experience in the area of continuous manufacturing in fine chemical, petrochemical, food, and pharma. In the pharma industry I have worked on continuous manufacturing of small molecules drug substance and drug products, and biologics upstream and downstream. My professional activities are mostly around process design and integration, process control and optimization, modeling and simulation, digital twin, scale-up, tech-transfer, and regulatory. Before starting my consultancy firm (Procegence) I served at the US FDA as a member of an expert team for advancement of emerging technologies to modernize pharmaceutical manufacturing.

What the most I like about the continuous manufacturing is a CM system is like a “symphony orchestra” where individual players, instruments, recipe, flow, segments and all work seamlessly to deliver a pleasant experience and product. However, all my experiences with well-designed stable CM lines have been very “boring”. When there is no disturbance, no alarm, no pushing material bins around, no paper batch recording,…… so fascinatingly boring!

I’m honored to partner with the brilliant members of the CMKC Advisory Board and am pleased to collaborate with all of you in progressing this very important topic in our industry.  By fostering healthy knowledge sharing, expertise, meaningful solutions and reducing barriers to continuous manufacturing, we can improve quality supply to patients with reduced supply chain complexity and risk to product.  Together, we can be the catalyst to positive changes.

My career spans 29 years in global pharma/biotech, including roles in Process Development, Manufacturing, Facility Start Ups, Regulatory, and Quality for large and small, clinical to commercial stage organizations, across multiple modalities and dosage forms.   I am greatly motivated by designing strategies and solutions that reduce complexity, improve safety and ultimately, provide reliable supply of life saving therapies to patients. 

I am currently the SVP of Quality and CMC Regulatory at ReCode Therapeutics, enabling the development of mRNA lipid nanoparticles for rare diseases, and CEO of Clarity Global, LLC Consulting, delivering efficient strategies to organizations transitioning from clinical to commercial operations.  

I look forward to engaging with all of you on this platform!