Beth Junker Email & Phone Number

Westfield, Nj

I provide guidance and perspective on science, strategy or execution for a range of bioprocess topics relating to antibodies, therapeutic proteins, recombinant and viral vaccines, and secondary metabolites. 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; and lean-six sigma and other operational excellence initiatives in development or manufacturing settings. [See www.bioprocessadvantage.com for additional details and contact information.]

Kenilworth, New Jersey

During the commercialization of several late stage programs, I provided scientific leadership to drug substance, drug product and analytical functions which strengthened deliverables in the areas of science-based risk assessment, process understanding, and manufacturing controls. My major focus was the preparation of global regulatory filings and regulatory responses. Publically disclosed filings to date include two monoclonal antibodies: KEYTRUDA as a breakthrough designation now approved by the FDA and EMA, and ZINPLAVA currently under priority review with the FDA.To achieve seamless transition from early to late stage activities, I led a cross-divisional team that developed quality-by-design (QbD) strategies for process and analytical methods. The QbD strategy successfully supported commercialization and global licensure activities. Another cross-divisional team developed an initial knowledge management strategy that successfully captured and transferred information as late stage activities rose. To prioritize and integrate initiatives across the clinical supply chain, I led a third cross-divisional team that generated a forward-looking strategy that matched future internal and external change drivers to the anticipated needs of clinical trials.My project execution activities arose from several major merger and acquisition activities. Active coordination of several integrations, shutdowns and knowledge transfers achieved targets for value capture and timeline commitments. For programs impacted by pipeline rationalization, I led international technology transfer and outsourcing efforts which met quality and delivery targets and enabled progress until the next decision milestone.

Rahway, New Jersey

Leadership of the pilot plant (up to 19,000 L scale) led to increased responsibilities for an expanded department that included small-scale laboratory and rapid protein production groups, along with pilot plant (up to 19,000 L in scale) and process development/scale up activities. In this role, I became a member of the Bioprocess Research and Development senior leadership team.Creating bandwidth for this expanded role, one early accomplishment was to successfully transition my direct pilot plant responsibilities while sustaining the operation’s previous high performance. During this period, the operation achieved a 10 year sustained reduction in contamination, reliable recombinant protein scale up including purification, and an extensive GMP computer system/data collection upgrade. Through identification and enabling of development synergies and flexibilities, I increased effectiveness of laboratory to pilot plant transfers, both within the department as well as the broader organization. To enable reliable and timely supply of novel protein candidates and basic research proteins, the newly established rapid protein production group improved its throughput to match demand (>175 proteins/year).

Rahway, New Jersey

Managing engineers, microbiologists, process supervisors , unionized operators, and contractors, I was directly responsible for the operations of a highly instrumented and computerized pilot plant (up to 19,000 L in scale) and its associated capital projects. Working closely with all levels of maintenance and partnering with engineering and construction firms, GMP and validation, and safety/environmental functions, I focused on reliable “reduction to practice” to expand capabilities. Installations for biotech processing as well as compounds with marine toxicity or high potency expanded flexibility to support an increasingly diversified pipeline. Large volume (2 L) frozen seed bags for microbial cultures reduced preparations by 75% and enabled off-hour inoculations. A comprehensive facility and utility retrospective validation correctly anticipated the CANCIDIS® pilot plant launch strategy, and passed pre-PAI and other internal audits.

Phd, Biochemical Engineering

Bse, Chemical Engineering