Women in Bioprocessing: Leadership, Innovation, and Career Growth in Biotech

This event is organized with BioProcess International Boston at the Bioprocess International conference. Learn more here.

Join a panel of accomplished women leaders from across the biopharmaceutical industry as they share how they are advancing innovation, leading technical and cross-functional teams, and navigating successful careers in bioprocessing and biomanufacturing. Drawing on expertise in process development, Manufacturing Science and Technology (MSAT), CMC, technical operations, and biomanufacturing, panelists will discuss how they navigate complex challenges such as process scale-up, technology transfer, GMP manufacturing, and cross-functional leadership while advancing therapies from development through commercialization. Attendees will gain practical insights into leadership, career development, mentorship, and the evolving role of digital technologies, automation, and artificial intelligence in shaping the future of bioprocessing.

Discussion Topics

💬 Career pathways and key competencies for success in bioprocessing, manufacturing, MSAT, CMC, and technical operations, including strategies for navigating complex manufacturing and commercialization challenges.

💬 Leadership lessons from women driving innovation in biologics, cell and gene therapy, and biomanufacturing, including decision-making in high-stakes environments such as process scale-up, technology transfer, and GMP manufacturing.

💬 Building and leading high-performing, cross-functional teams across process development, manufacturing, quality, regulatory, and CMC to successfully advance biologics and advanced therapies.

💬Insights into how digital manufacturing, process optimization, automation, artificial intelligence, and data analytics are transforming bioprocess development and manufacturing.

💬 Mentorship, sponsorship, and strategies for career advancement and leadership development in the evolving biopharmaceutical industry.

***AWIS members can apply for complimentary Friday passes and can benefit from a 30% discount on full conference registration***

Speakers

🎤 Amy Shaw, Senior Director, Process Development at Genetix Biotherapeutics

🎤 Deniz Temel, Director, CMC & Analytical Development at Third Arc Bio

🎤 Melanie Matheu, Co-Founder and CSO, Lyric Bio

🎤 Janet Chung, CMC Project Manager, Rocket Pharmaceuticals

MODERATOR: Pamela Klecki, President, Association for Women in Science, Massachusetts (Boston) Chapter

Janet Chung, Ph.D. is an accomplished biopharmaceutical leader with deep expertise in gene therapy product development, spanning research, process development, CMC strategy, and GMP manufacturing. She led a high-performing cross functional CMC team to advance DB-OTO AAV gene therapy program from preclinical research through IND and supported late stage development leading to recently FDA approved Otarmeni, the first AAV gene therapy to restore hearing in children with OTOF related hearing loss. Throughout her career, Janet has championed career pathways and key competencies essential for success in bioprocessing and technical operations, while serving as a mentor and sponsor for emerging women leaders driving innovation in cell and gene therapy. She is deeply committed to translating breakthrough science from bench to bedside and delivering transformative medicines to patients in need.

Amy Shaw is the Senior Director of Process Development at Genetix Biotherapeutics, where she leads process development strategy for advanced cell and gene therapy programs. With more than 12 years of experience spanning process development, CMC strategy, manufacturing, and technical operations, she has led the development of cell and gene therapies from early research through IND submissions and early clinical manufacturing. Prior to joining Genetix Biotherapeutics, Amy held leadership roles at Takeda Pharmaceuticals, where she most recently served as Head of Process and Product Development for Cell Therapy, overseeing end-to-end process development strategy across the company's cell therapy portfolio. Earlier in her career, she held technical leadership positions at Beam Therapeutics and Torque Therapeutics, where she established and scaled process development organizations and advanced novel allogeneic and autologous cell therapy programs. She also contributed to the development of Kymriah® while at Novartis Institutes for BioMedical Research, supporting one of the first commercially approved CAR-T therapies.

Deniz B. Temel, Ph.D. is Director, CMC & Analytical Development at Third Arc Bio. Her path into biotech leadership began unconventionally: she trained as a physics teacher in Turkiye before earning a Ph.D. in Physics (Biophysics/Structural Biology) from CUNY, where she used NMR spectroscopy to study protein structure. A postdoc at Biogen Idec launched her industry career, taking her through Amgen, Bristol Myers Squibb discovery followed by development, and now Third Arc Bio, where she leads CMC and analytical strategy for complex biologics (bispecific/trisecific antibody) programs from early development through IND filing and clinical development, building global CDMO networks along the way. Her first love, teaching, has never left her. She's passionate about breaking down complex science into simple terms so anyone, regardless of background, can understand it, and she brings that same gift to mentoring the next generation of scientific leaders.

Dr. Melanie Matheu is an immunologist, inventor, and biotech entrepreneur. She earned her PhD in Physiology and Biophysics, with an emphasis in Immunology, from UC Irvine, followed by postdoctoral training at VIB (Ghent University) and UCSF, specializing in two-photon laser imaging of immune responses. In 2016, she left academia to found Prellis Biologics, commercializing a holographic laser-based 3D bioprinting system she invented. As CEO for six years she raised over $65M and led Prellis's COVID-era pivot to bioprinted human lymph-node organoids for antibody discovery. In 2024, she co-founded Lyric Bio as CSO. Lyric Bio is focused on developing ultra-high-density 3D bioreactors to manufacture human donor derived therapeutics such as IVIg more efficiently. Today Lyric Bio, Inc has demonstrated the feasibility of ultra-high-density cell culture, routinely reaching densities of 1 billion cells per mL.

Event location: Hynes Convention Center, Innovation and Community Stage