About BioProcess Advantage LLC

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BioProcess Advantage LLC is an independent, woman-owned consulting firm based in New Jersey. Beth Junker is the principal consultant and sole owner. BioProcess Advantage LLC provides guidance and perspective on science, strategy and execution for a range of bioprocess topics.  

Specific areas include: early and late stage bioprocess develo

BioProcess Advantage LLC is an independent, woman-owned consulting firm based in New Jersey. Beth Junker is the principal consultant and sole owner. BioProcess Advantage LLC provides guidance and perspective on science, strategy and execution for a range of bioprocess topics.  

Specific areas include: early and late stage bioprocess development activities including quality-by design and knowledge management; CMC (Chemistry, Manufacturing and Controls) sections of global regulatory filings and health authority responses; identification of science-based risks

and mitigations; lean-six sigma and other operational excellence initiatives in development, manufacturing or supply chain settings.  

Selected projects include expedited programs, development / operating models, IND- and BLA- enabling activities, clinical / commercial

supply chains, and due-diligences. 

Clients range from small start-ups to mid-size

biotechs to multinational entities.

With over 27 years of experience as a results-oriented and adaptable scientific leader, Beth Junker has developed a substantial cross-functional and cross-disciplinary skill set. She has a proven ability to contribute both technically and strategically in atmospheres of rapid change and increasing complexity that are associated with new p

With over 27 years of experience as a results-oriented and adaptable scientific leader, Beth Junker has developed a substantial cross-functional and cross-disciplinary skill set. She has a proven ability to contribute both technically and strategically in atmospheres of rapid change and increasing complexity that are associated with new products and modalities. Her expertise in bioprocess development and commercialization has contributed to commercial filings and (in some cases pending) global approvals of a variety of bioprocess-derived products for secondary metabolites (CANDIDAS), vaccines (VAQTA), biosimilars (LUSDANA) and monoclonal antibodies (KEYTRUDA, ZINPLAVA, ILUMYA).

Other career highlights include:

• She provided scientific leadership to drug substance, drug product and analytical functions in areas such as science-based risk assessment, process understanding, process and analytical comparability, and manufacturing controls. 
• She led several strategic initiatives, including development of quality-by-design frameworks, that subsequently supported commercialization and global licensure. 
• She increased effectiveness of internal laboratory to pilot plant technology transfers, and also led external international technology transfers to sites in the EU and Asia.   
• She was directly responsible for a state-of-the-art bioprocess pilot plant and its associated capital and technology development projects, and improved capabilities and flexibility to support diverse pipeline needs. 
• She has been an innovative business process champion, earning certifications as a Lean Six Sigma Master Black Belt, change execution leader and project manager.

Selected recent publications include:

• “Knowledge management elements in support of generation of CMC regulatory documentation” in A Lifecycle Approach to Knowledge Excellence in the Pharmaceutical Industry Taylor & Francis (2017)
• “QbD for analytical methods” in Vaccine Analysis: Principles & Strategies Springer (2015)
• "Building a business ca

Selected recent publications include:

• “Knowledge management elements in support of generation of CMC regulatory documentation” in A Lifecycle Approach to Knowledge Excellence in the Pharmaceutical Industry Taylor & Francis (2017)
• “QbD for analytical methods” in Vaccine Analysis: Principles & Strategies Springer (2015)
• "Building a business case for biopharmaceutical QbD implementation" Biopharm 25(8): 40-47 (2012)
• "Design-for-six-sigma for development of a bioprocess quality-by-design framework" PDA J Pharm Sci Technol 65(3): 254-286 (2011)
• “Design-for-six-sigma to develop a bioprocess knowledge management framework” PDA J Pharm Sci Technol 65 140-165, (2011)
• "Minimizing the environmental footprint of therapeutic protein & vaccine bioprocesses", parts 1 & 2 Bioprocess Intl 8(8): 62-72 & 8(9): 36-46 (2010)
• "Bioprocess monitoring and computer control: Key roots of the current PAT initiative” Biotechnol Bioeng 95(2):226-261 (2009)

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Selected recent invited presentations include: 

• “Today a caterpillar, tomorrow a butterfly: The transformation of bioprocess analytics” Keynote, CHI Peptalk (2017)
• "Quality risk management and its ties to knowledge management throughout the (bio)pharmaceutical product lifecycle” Keynote, QRM Summit, (2017)
• “Realizing the best interest tomorrow on today’s knowledge investments” IFPAC (2017)
• “Life in the Fast Lane: Developing & commercializing Keytruda (a novel breakthrough designation oncology therapy) in 3 yrs from 1st patient dosed to US approval” Cell Culture Engineering XV (2016)
• “Integrated approaches to developing a biotech product-specific process validation lifecycle strategy” ISPE (2012)
• “What scales up, must scale down—Spinning wheels?” Keynote session address, 2nd Annual Scaling up & down with optimized bioreactors & disposables (2012)