Anxhela Kole
Quincy,MA
Summary
Accomplished biopharmaceutical professional with extensive experience in gene therapy and biologics, guiding projects from development to clinical manufacturing. Expertise in downstream process development and drug product formulation, facilitating technology transfer and manufacturing support. Proven leadership in cross-functional CMC strategies for complex biologic and viral vector products.
Overview
20
20
years of professional experience
Work History
Director/Associate Director, Downstream process development
Ensoma
04.2021 - Current
- Directed a cross-functional team to develop and optimize downstream processes for biologics production and drug product formulation for clinical programs.
- Led the development, optimization, and validation of downstream processes (including chromatography, filtration, and formulation) for Helper Dependent Adenovirus.
- Directed process characterization studies to understand critical quality attributes (CQAs) and process parameters, ensuring robust and scalable processes.
- Oversaw drug product formulation strategy, executing co-formulation, aseptic filling, and in-use stability studies to support Phase I/II trials.
- Directed global technology transfer programs spanning R&D, pilot scale, and GMP manufacturing, establishing scalable, compliant downstream processes and ensuring seamless integration into clinical supply chains.
- Championed GMP readiness efforts through facility fit assessments, tech transfer readiness frameworks, operator qualification, and alignment of batch records, SOPs, and digital manufacturing systems with process requirements.
- Influenced strategic CMO/CDMO partnerships by setting expectations for process performance and defining tech transfer deliverables, ensuring manufacturing sites were prepared for clinical and commercial supply.
- Built and mentored a high-performing team, fostering innovation, collaboration, and professional growth.
- Authored and reviewed CMC sections of IND submissions, translating process development, analytical, and manufacturing data into regulatory-ready documentation supporting advancement of gene therapy programs into the clinic.
- Provided executive-level oversight as Person-in-Plant (PIP) during GMP manufacturing campaigns, guiding real-time decision-making, resolving on-floor issues, and safeguarding batch success under accelerated timelines.
Senior Scientist, Group lead, downstream process development
Generation bio
10.2019 - 04.2021
- Led and mentored a team of three scientists supporting downstream process development for genetic medicine programs.
- Directed process optimization and robustness studies to improve process performance, scalability, and manufacturing readiness.
- Established project priorities and allocated resources to align with program milestones and support organizational objectives.
- Presented development strategies, experimental outcomes, and risk assessments to CMC, MSAT, and cross-functional leadership, enhancing decision-making and project alignment.
- Fostered cross-functional collaboration among process development, manufacturing, analytical development, and quality teams to streamline workflows and improve project outcomes.
- Led technology transfer activities at multiple CDMO sites, including batch record authoring and review, operator training, manufacturing support, and Person-in-Plant oversight during production campaigns.
Scientist, Downstream Process Development
Generation Bio
05.2018 - 10.2019
- Lead scientist on the development of key unit operations as related to the process such as depth filtration, and multiple chromatography steps.
- Collaborated with a 3-person team to design downstream process for novel DNA product, enhancing overall process efficiency.
- Participated in multiple technology transfers simultaneously, facilitating process scalability.
- Supported large-scale production processes, optimizing efficiency for internal operations and external vendor collaboration.
- Authored and evaluated downstream batch records for internal and vendor compliance, ensuring accuracy and clarity.
- Interface with upstream development and analytical development to ensure proper information flow around process changes and effects on other teams.
Process Engineer II / Senior Associate Scientist
Momenta Pharmaceuticals inc
01.2015 - 04.2018
- Conducted technical reviews of manufacturing records and SOPs to ensure compliance and quality standards.
- Provided technical expertise for improvements in process efficiencies in terms of throughput, reproducibility and overall recovery.
- Interfaced with upstream development, formulation/drug product and analytical development to ensure that processes are executed in a timely manner.
- Collaborated with upstream development, formulation/drug product, and analytical development to synchronize process execution and meet project timelines.
Associate Scientist II
Biogen Idec
10.2013 - 01.2015
- Contributed to three-person team in Biogen Idec Hemophilia department, enhancing purification development of coagulation factors.
- Developed and modified purification protocols for FVII, FVIII, and FIX coagulation factors to optimize performance.
- Developed E. coli expression and purification protocol for two new sickle cell targets.
- Coordinated efforts between purification and expression teams to enhance project planning between the purification and expression team for planning and coordinating projects.
- Maintained timely electronic notebook and presented data regularly in weekly Hemophilia meetings.
Research Assistant III
Wyss Institute, Harvard Medical School
06.2012 - 10.2013
- Designed and executed protein stability studies to assess and enhance protein integrity and performance.
- Develop and execute multi step purification protocols and SOPs for over 40 proteins related to the project.
- Conducted tests on protein functionality in pathogen separation ELISA to validate assay effectiveness.
- Managed inventory and supplied protein-coated magnetic beads to internal and external collaborators, ensuring availability of key project ingredients.
Senior Research Associate/Laboratory Coordinator
Blue Sky BioProducts
01.2007 - 06.2012
- Designed protein purification experiments and executed them from start to finish.
- Replicated and modified client protocols to maximize yield and purity.
- Compiled comprehensive reports to support project outcomes.
- Managed multiple client projects concurrently as project lead, ensuring timely delivery of results.
- Monitored laboratory inventory levels to ensure availability of necessary supplies. and ordered supplies.
- Conducted training sessions for new hires to ensure understanding of procedures and expectations.
Education
Master of Science - Biotechnology
Worcester State University
Worcester, MA05-2012
Bachelor of Science - Biology, Chemistry
Clark University
Worcester05-2007
Skills
- Downstream process development
- Gene therapy advancement
- Viral vector purification
- Technology transfer
- GMP manufacturing
- Manufacturing readiness support
- Process scale-up
- CDMO management
- Regulatory submissions (IND)
- Team leadership
- Process characterization
Publications
- An Extracorporeal Blood Cleansing Device for Sepsis Therapy, Joo H Kang, Michael Super, Chong Wing Yung, Ryan M Cooper, Karel Domansky, Amanda R Graveline, Tadanori Mammoto, Julia B Berthet, Heather Tobin, Mark J Cartwright, Alexander L Watters, Martin Rottman, Anna Waterhouse, Akiko Mammoto, Nazita Gamini, Melissa J Rodas, Anxhela Kole, Amanda Jiang, Thomas M Valentin, Alexander Diaz, Kazue Takahash, Donald E Ingber, Nature Medicine, 2014
- Purification of Chimeric FVIII Molecules, Lily Zhu, Anxhela Kole, John Kulman, Marisol Acosta, US20160185817 A1, EP 3043813 A4, EP 3043813 A2, WO 2015021423 A3, WO 2015021423 A2, 06/30/16, 11/30/16, 07/20/16, 11/05/15, 02/12/15
Timeline
Director/Associate Director, Downstream process development
Ensoma
04.2021 - Current
Senior Scientist, Group lead, downstream process development
Generation bio
10.2019 - 04.2021
Scientist, Downstream Process Development
Generation Bio
05.2018 - 10.2019
Process Engineer II / Senior Associate Scientist
Momenta Pharmaceuticals inc
01.2015 - 04.2018
Associate Scientist II
Biogen Idec
10.2013 - 01.2015
Research Assistant III
Wyss Institute, Harvard Medical School
06.2012 - 10.2013
Senior Research Associate/Laboratory Coordinator
Blue Sky BioProducts
01.2007 - 06.2012
Master of Science - Biotechnology
Worcester State University
Bachelor of Science - Biology, Chemistry
Clark University