Amy Rafferty Email & Phone Number

• Assist/lead development and implementation of various deliverables associated with project plans to ensure timely execution and meet project deadlines• Work with cross-functional teams to implement various engineering changes with respect to design/manufacturing drawings, DMRI updates, process documentation updates, design reviews, etc.• Assist/lead on production protocols to qualify and implement new manufacturing processes

• Functioned as a Product Lead for various commercial products to facilitate end-to-end progression through the manufacturing cycle• Responsible for reviewing key technical documents (i.e. manufacturing summary reports and Critical Parameter reports) related to product control and production• Responsible for authoring atypical investigations related to batch execution• Responsible for authoring and reviewing change controls related to documentation changes necessary to support commercial production

• Responsible for directing a team of Product Stewards who maintain the health of key revenue drivers through product reviews, the Continued Process Verification program, and performance tracking• Responsible for reviewing and approving key technical documents (i.e. optimization and qualification batch protocols/reports, technical atypical investigations, and corrective/preventative actions)• Responsible for driving ownership and accountability for sustained continuous improvement efforts

• Responsible for overall shift leadership including managing personnel and quality-related issues that occur during the shift• Responsible for ensuring the facility is in a constant state of audit-readiness

• Responsible for the supervision of hourly employees on the production floor during commercial manufacture to ensure SOPs and cGMPs are followed• Responsible for authoring atypical investigations related to batch execution and proposing adequate corrective/preventative actions

• Responsible for planning and coordinating the manufacture of sterile liquid parenterals (vaccines and biologics) and pharmaceuticals for clinical and Formal Stability studies• Responsible for the indirect supervision of hourly employees on the production floor during batch manufacture to ensure proper aseptic technique and cGMPs are followed• Responsible for the review of batch records and ancillary documentation to facilitate batch release for clinical or stability use• Responsible for authoring atypical investigations related to batch execution• Functioning as the area manual visual inspection subject matter expert specifically regarding procedural alignment with applicable regulations, training, and qualification• Championed a team to increase manual visual inspection output and earned Black Belt certification• Functioned as the single point of contact between development groups and the pilot plant to manage the long-range production schedule• Functioned as the liaison between the pilot plant, development groups, and the materials management area for the quarterly forecasting of raw material and packaging components to support inventory management

Nov 2007 – Jun 2008 Analyst – Sterile & Liquids Commercialization, West Point, PA• Provided integration support for the use of disposable single-use technology during the manufacture of biologic clinical supplies in the Sterile & Liquids Pilot Plants• Studied the effect of formulation and filling process variables on the drug product quality of a vaccine product utilizing Design of Experiments• Performed lab-scale experiments to directly support the development of several vaccine and biologic products• Functioned as the manager of one of the development laboratories ensuring the lab maintained 5S certification and personnel utilizing the lab followed appropriate safety and waste disposal proceduresApr 2007 – Oct 2007 Analyst – HPV Purification, West Point, PA• Championed a team to reduce the cycle time of in-line buffer manufacture for a vaccine purification process by 23% and earned Green Belt certification• Collaborated with Bio/Sterile Validation personnel to complete the annual assessment of automated clean-in-place cycles for process tanks• Participated in CBE-30 document reviews regarding the addition of a new virus type into the licensed manufacturing facilityJul 2006 – Mar 2007 Analyst – Global Technical Operations, Danville, PA• Coordinated cleaning changeovers for fixed processing equipment between product campaigns• Functioned as the technical lead for the solvent recovery process supporting the transfer of an API process from the Rahway, NJ site to the Danville, PA site• Provided technical support on the factory floor and led shift huddles while on rotating 12-hour shifts

Performed resin screening studies to determine the best resins based on selectivity and the most optimal running conditions based on desired yieldInitiated an automated HETP/asymmetry method on the AKTA to facilitate the column packing evaluation process

Conducted experiments to collect basic data for the design of a simulated moving bed chromatography process for the purification of monoclonal antibodiesStudied the effects of concentration and aggregation on virus filtration membranes to gain a better understanding of the membrane fouling mechanism

Developed methods to determine protein concentrations using high performance liquid chromatographyUsed dynamic light scattering to study the changes in the molecular size and aggregation of protein solutions throughout a monoclonal antibody purification process