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Kristen Manchester

@kristenmanchester

Biopharma PMO Program Director at Cytiva, coordinating an eight-project innovation program across business units.

At Cytiva, I lead a strategic innovation program across business units, coordinating eight related projects and their budget. I established program governance, a roadmap, shared metrics, and decision practices to make progress and risks visible.

Before that, I led product management for digital solutions at Cytiva, including the launch of Data Bridge for electronic access to raw material release data and lot genealogy. I also developed a proof-of-concept tool to automate regulatory documentation.

At Bristol-Myers Squibb, I worked across technical strategy, manufacturing science, and process development. My work included supporting technical transfer and facility qualification, contributing to CMC strategy, and supporting drug substance manufacturing campaigns.

Experience

Work history, roles, and key accomplishments

Research Scientist, Downstream Process Development

Aerotek @ Bristol-Myers Squibb

Aug 2004 - Oct 2005 (1 year 2 months)

Conducted laboratory studies to develop downstream process for biologic asset. Screened resins, conducted impurity clearance studies, and assessed feasibility of using chaotropic agents to optimize yields.

Downstream Process Development Resin Screening Impurity Clearance Laboratory Testing Biologics

Associate Director, Integrated Technical Strategy

Bristol-Myers Squibb

Technical Product Team Lead for two late-stage clinical programs with oversight of drug substance, drug product, and analytical activities. Partnered with manufacturing sites and brand teams to establish technical agenda, CMC strategy, and business continuity plan.

Technical Leadership CMC Strategy Quality Risk Management Process Improvement Change Management Cross Functional Collaboration

Director, Integrated Process Development

Cytiva

Built and led a diverse team to identify evolving customer needs in Process Development and explore the benefits of full-process Design of Experiments and online sensing. Established a baseline of drug substance process development activities required to support CMC packages.

Process Development Design of Experiments (DOE)Online Sensing CMC Strategy Team Leadership Proof of Concept Development

Senior Product Strategy Manager, Automation & Digital

Cytiva

Drove manufacturing execution system (MES) and digital product portfolio to integrate with Cytiva's biopharma equipment offerings, including technical roadmap for sensors and new product introductions. Collaborated with internal and external partners to anticipate emerging market needs.

Product Strategy Manufacturing Execution Systems Digital Products Technical Roadmap Market Analysis Collaboration

Associate Scientist, Manufacturing Support

Bristol-Myers Squibb

Provided support to drug substance manufacturing during tech transfer, clinical, and process qualification campaigns. Authored campaign summary reports, change controls, and conducted process monitoring and quality event investigations.

Manufacturing Support Tech Transfer Process Qualification Change Control Root Cause Analysis Corrective Actions

Director, Prescriptive Batch

Cytiva

Product Management leader of a team developing digital solutions to solve process variability problems, including the launch of Cytiva's Data Bridge. Leveraged customer insights and market research to define requirements for Prescriptive Batch to enable 'on-target' manufacturing.

Product Management Digital Solutions Market Research Customer Engagement Program Management Process Analytical Technologies

Senior Engineer, Manufacturing Science and Technology (MS&T)

Bristol-Myers Squibb

Drug Substance Process Lifecycle Manager and Designated Accountable Person for global regulatory submission with breakthrough designation. Supported technical transfer and qualification of large-scale commercial facility.

Process Lifecycle Management Regulatory Submissions Technical Transfer Manufacturing Sciences Quality Inspection Support

Scientist, Downstream MS&T

Bristol-Myers Squibb

Led downstream team through full development and characterization of a late-stage clinical program working closely with an external partner. Served as CMC author and subject matter expert.

Downstream Processing Process Characterization CMC Authoring Subject Matter Expertise Team Leadership Mentorship