Lance Rogers Mba, Pmp, Lssbb Email & Phone Number

Boston, Massachusetts, Us

• Spearhead strategic planning, forecasting and management of Technical Operations annual budget with a 5-year forecast.• Worked directly with Financial Planning and Analysis (FP&A) to establish CMC accruals and cash flow processes.• Leadership of CMC Project Management Office ensuring effective, high-quality delivery of CMC projects on time and within budget.• Collaborate with C-suite executives to align operations with business strategy and goals.• Spearheaded Technical Operations outsourcing strategy to set organizational processes for vendor selection and acquisition.• Drive cross-functional collaboration, fostering effective communication, and ensuring alignment across teams.• Participate in talent acquisition and retention efforts. Foster a culture of high performance, innovation, and continuous improvement.Notable Contributions:• Establish and defended Technical Operations operating budget during long range financial planning (with approval) for fiscal years 2024 through 2029, including commercial products and R&D spend for multiple programs.• Established operational processes, based on FP&A requirements for accrual and cash-flow accounting at the project level capable of meeting SOX audit requirements.• Set strategic outsourcing goals including identifying and incorporating a primary Biomanufacturing outsourcing partner and a North America analytical testing partner into the AVEO supply chain.• Built a CMC project management team and established standard practices and KPI's for continuously improving operations.

Gaithersburg, Maryland, Us

Durham, North Carolina, Us

Account manager for strategic KBI clients, which includes: Working with clients to identify critical needs and solutions provided by KBI technical services. Design contracts based upon client needs including fee for service and full time equivalent sourcing approaches. Establish pricing models and justifications. Write and manage client contracts and act as program manager for execution of internal and external resources.

Lancaster, Pa, Us

Oversaw strategic integration of several critical organizational activities such as design, testing and introduction of electronic notebooks into testing laboratories, construction of a corporate stability storage site and design of a 150,000 s.f. lab expansion project. Developed business strategy for the introduction of a new outsourcing model to support management of pharmaceutical assets from candidate selection through IND and phase one clinical studies.

Bridgewater, N.J, Us

Operations manager accountable for technical leadership of multiple assets in various stages of development (phase I - IV). Responsible for managing the delivery of active pharmaceutical ingredients (API) and drug products to global clinical and manufacturing teams and for managing a wide array of national and international contracted manufacturing and research organization teams (CMO/CRO).

Brentford, Middlesex, Gb

Work in an international matrix team environment interfacing with key project stakeholders to deliver various materials world wide. Key analytical point of contact between Contract Research Organizations and R&D External Supply for a number of GlaxoSmithKline assets. Apply continuous improvement strategy throughout the drug delivery process using lean six sigma tools where appropriate.Directly responsible for delivery of API, intermediates and drug product to toxicological and clinical sites, world wide. Manage analytical assests through analytical development, method validation and transfer, release and stability testing. Responsible for quality control of data and testing and allocation of resource to meet vascillating timelines.

Brentford, Middlesex, Gb

Utilized differential development for the development and progression of several GSK projects. Worked in a matrix team environment as a technical line lead for multiple concurrent projects.Direct responsibilities included: Development, validation and implementation of early phase analytical methods (discovery to phase II) for the analysis of API, intermediates and drug products; closely interacted with drug metabolism and pharmacokinetics to provide analytical support for the formulation development and selection of toxicology vehicles and dosing materials; forging collaborations with chemical engineering and chemistry groups to support the form/version screen of early development API; managing stability programs; release of clinical API's and drug products; quality control of data generated and documentation of regulated processes.

Brentford, Middlesex, Gb

Responsible for successfully developing, validating and implementing late phase analytical methods (phase III – IV) for drug product analysis; managing stability programs for several late stage assets; writing analytical sections of NDA's and other regulatory documents; transfer of late phase methodology and products from research and development to global manufacturing; analytical point of contact for multiple late phase key stakeholders (regulatory, safety, quality assurance, packaging, etc...).

New York, New York, Us

Responsible for development, validation and implementation of early phase analytical methods from candidate selection through phase II for active pharmaceutical ingredients and drug products; transfering early development methodology to late phase development; providing analytical support to synthetic development and early phase formulation development; authoring analytical sections of IND level documents for regulatory filings.

New York, New York, Us

Master Of Business Administration (M.B.A.), Business Administration And Management, General

Bachelors Of Science, Chemistry/Molecular Biology