Samantha Hulbert Farland Email & Phone Number

Waltham, Massachusetts, Us

Waltham, Massachusetts, Us

Waltham, Massachusetts, Us

Waltham, Massachusetts, Us

• Establish strong partnership with the scientific lead to shape the overall strategy, objectives and work plan for assigned program(s) • Develop and maintain an integrated program plan (e.g., detailed Gannt, budget, resources, etc.) encompassing key program milestones and deliverables in alignment with program objectives• Facilitate program team meetings using meeting management best practices to drive cross-functional communication, timely and effective decision-making, and successful execution of program activities• Proactively identify risks, gaps, and resource bottlenecks, and work with impacted teams and functional leadership to develop and implement mitigation plans• Lead the building of detailed program budgets with scientific staff and finance and partner with finance to keep program(s) on budget• Build and maintain strong working relationships with scientific lead, internal departments and external partners to ensure the program remains on-track• Develop & deliver impactful presentations that effectively distill complex issues to the critical points, and lead to increased understanding and optimized strategic planning & decision-making • Support the standardization of processes and communication(s) in order to build efficiencies within the department and across R&D teams• Proactively seek out opportunities for organizational improvement (e.g. team structure, processes, communication, etc.)

Waltham, Ma, Us

● Lead the planning, executing, and closing of cross-functional customer projects, by working with key internaland external stakeholders.● Introduction of new process development, analytical method development and qualification, equipmentpurchase and qualification.● Creation of a project plan, identifying required resources, tracking of progress, and communicating deviationsboth internally and externally to drive resolution and assess financial impact.● Identify and mitigate potential project risks with the team and develop mitigation strategies, report progress,issues, and risks to all stakeholders.● Plan and deliver all stages of the project within a matrix organization.● Facilitate decision making within the team to drive progress to completion during execution.● Work with Commercial Operations to generate change orders as required during the execution of the program.● Communicate program status, including elevation of issues as needed, to key internal and external stakeholders.

Waltham, Ma, Us

● Manage outsourced testing needs, timelines, risk mitigation and business priorities● Oversee all stability activities and confirm compliance with stability guidelines and company SOPs● Work with cross-functional joint core teams to ensure client deliverables are met according to establishedtimelines● Review/analyze testing protocols generated by CTLs for cGMP production lots including engineering and clinicallots and associated cell and viral banks● Ensure that external testing and stability activities meet project and production objectives● Review analytical and stability test records and external reports● Communicate testing priorities, evaluate stability trends, prepare reports and COAs● Author and/or review Quality Control SOPs, Deviations, Memos, Change Controls, and CAPAs● Work with internal and external auditor

Waltham, Ma, Us

● Plan, coordinate and manage all stability operations and ensure quality products and systems● Develop stability protocols, sample and test requirements, conditions for testing as per industry guidelines andcompany SOPs● Work closely with Manufacturing, Quality Control and Quality Assurance to schedule and coordinate activitiesrequired to execute product stability studies● Review all stability test records and external reports● Evaluate stability trends and prepare reports● Review of SOPs, and the writing of QC test records, Assay Qualification Addendums, Raw MaterialSpecifications and CAPAs● Work closely with vendors to expense and m

East Rutherford, New Jersey, Us

● Perform cleanroom monitoring including viable air and surface sampling, total particulate samplingand proper gowning● Plate reading and microbial identification● Follow testing and other laboratory requirements as documented in SOPs for cGMPs