Derek Kichula Email & Phone Number

Philadelphia, Pennsylvania, Us

Oversight of lab/site operations and the Tech. Ops. budget/spend plan, with a focus on business planning and strategic decision making. This is done by leveraging various business planning tools including financial & resource models, activity forecasts, and sensitivity analysis. Additionally, this role represent the Tech. Ops. department on the Asset/Technical Development Team for Passage Bio's leading drug candidate, PBFT02. This is a cross-functional team of representatives from R&D, Supply Chain, Clinical, Finance, Business Development, etc. that create integrated departmental plans/milestones/risk assessments to drive the progression of the asset through its development lifecycle.

Philadelphia, Pennsylvania, Us

Responsibilities:• Ownership of the CMC lab’s capex and opex annual budgets • Management of all site support services (Engineering, Facilities, Validation, Maintenance, Procurement, Warehousing (GMP), and Project Management)• Creation of business cases for site growth & reliability investments (eg. GMP & non-GMP MFG Internalization, late-stage development & method validation capabilities, instrument reliability, etc.)Projects:• Start-up of internal CMC Laboratory – Investment enabled the following functionalities: Analytical & Process Development and QC Testing to support all of Passage’s clinical assetso Established and hired all site support functions (Capital project teams, Engineering, Facilities, Maintenance/Metrology, Validation, Procurement, Warehouse, Project Management)• Established a Site Demand Management Process• Established budget management practices for both Opex and Capex spend

Philadelphia, Pennsylvania, Us

Responsibilities:• Provide technical process support with batch record, deviation, and change control reviews• New facility establishment with equipment capacity/redundancy, facility fit, and GMP readiness assessmentsProjects:• Collaborated with partner CMO to start-up a dedicated Viral Vector GMP manufacturing suite

Waltham, Ma, Us

Responsible for Production, Manufacturing Science, Validation, and Supply Chain for the start-up of a new cell therapy production facility.

Waltham, Ma, Us

Management of Process Engineering (Tech Transfer, Production Support, and Process Validation) and Plant Engineering (Responsible Equipment Owners) teams for Upstream (USP), Downstream (DSP), utilities, labs, and automation. (24 FTEs)

Waltham, Ma, Us

Responsible for all site capital projects, tech transfer of new technology programs/platforms, equipment reliability, and overall site management. Responsible for 15 FTEs.

Waltham, Ma, Us

Responsibilities:• Manage all production related capital projects. • Responsible for all process, automation, and architectural engineering activities.• Responsible for reliability and maintenance of all production equipment. Projects:• Lead all engineering design and installation activities for a 1000L Single Use Bioreactor (SUB).• Reduced operation time by 50% for a 2500L bioreactor Sterilization-in-Place (SIP) process.

Villanova, Pa, Us

MBA Candidate at Villanova University

St. Louis, Mo, Us

St. Louis, Missouri, Us

Accomplishments:• Built a stability suite that resulted in a two-fold increase in operational capacity. • Expanded the cell culture scale up capacity by 300% and increased reliability.• Created a Capital Project System to efficiently scope, assess, and implement capital projects.• Implemented a Work Request/Work Order system that tracks over 3,000 annual requests.• Designed and prepared PM work plans for various pieces of equipment including a 2500L stainless steel bioreactor, a Clean in Place (CIP) system, and centrifuges. The development of each work plan was based upon the equipment’s Operations and Maintenance (O&M) Manual, operations experience, and budget.

San Ramon, California, Us

Cleaning Validation, Swiftwater, PA Worked with a validation team for the cleaning validation of a multi-million dollar facility expansion and retrofit.--Authored and reviewed development and validation protocols and reports. --Worked with team to complete COP validation of process cleaning cycles.--Led a team of engineers to investigate the validated cleaning cycle for two (2) manufacturing scale UF/DF systems.Process Design Engineer, Chicago, Il Worked with a team of process engineers for the detail design and start-up of two multi-million dollar capacity expansion projects.--Worked under senior process engineers to review and revise Instrument Design Specification (IDS) and P&IDs.--Assisted purchasing team to organization and revise equipment orders from vendors.

San Ramon, California, Us

San Ramon, California, Us

Organize start-up operations for a new contracting business. This includes hiring and developing reliable employees, develop and expand market presence, perform construction assessments, authorize contracts, and manage general day to day business and production operations.

Us

Gaithersburg, Maryland, Us

Protein Purification

Biological Systems Engineering, Bioprocess

Education record

Education record