Joye Bramble Email & Phone Number

Exton, Pa

Exton, Pa

• Developed organizational structures, career ladders, and hired staff supporting startup of a new 60,000 sqft pilot plant for monoclonal antibody production• Organized, prioritized, and managed development of 23 new business process systems to support running the GMP facility including compliance, safety, engineering systems, and process transfer and ensured generation of over new 230 SOPs• Managed expense budget of $6 million and support capital budget of $80 million• Supported final specification, design, qualification and startup of process equipment• Led facility startup with a model product and 2 successful GMP campaigns providing materials for development, preclinical and phase I/II clinical studies

• Led an organization of 150 staff (Direct Reports: 3 Sr. Directors and 8 Directors) at six sites in 3 countries, including Japan, that provided business support for the MRL President and his management team. Redesigned organization and recruited staff (9 Directors and Managers in 12 months) to support new Target to Phase IIB Franchise Executives.• Developed therapeutic area and capability strategies, operational plans, objectives, resource plans, profit plans and long range operational and capital plans for MRL. Involved extensive interactions in a “chief of staff” role with subdivision heads and franchise leaders.• Led or participate in the development of pipeline management methodologies, tools, and datasets for research integrating assessment of risk, value, timing, and costs for the Target through IIB programs. Presented pipeline flows to the president of MRL at quarterly Operational Reviews.

• Developed TP Business Strategy for research and manufacturing.• Established contract manufacturing strategy for the manufacture of TPs. Selected manufacturing partners (Lonza and Boehringer Ingelheim), established partnership approaches, aligned technology platforms across companies and managed contract and supply agreements in excess of $100 million.• Forecasted demand for TPs and ensured timely supply from manufacturers for development of products from safety assessment through Phase I to III and Launch. Developed new cross-divisional, cross-organizational demand management process integrating research, manufacturing and marketing.

• Led department of 130 staff responsible for bulk clinical supply manufacture for biological (vaccine and therapeutic proteins) products including management of two facilities, the Biologics Pilot Plant (West Point, PA) and the Fermentation Pilot Plant (Rahway, NJ), and management of all clinical supply outsourcing. Ensured production of bulk supplies for safety assessment through Phase IIB. Managed a budget in excess of $30 million.• Developed business processes to integrate facility and department into Merck product development life-cycle including establishment of new clinical supplies team structures and biologic product prioritization processes. • Led the Bioprocess R&D Steering Committee which reviewed and approved all clinical supply campaigns and planning for biologics and vaccines. • Created an MRL Site Master File and achieved compliance with EU standards as a member of the EU Clinical Trials Directive (CTD) Team.• Successfully passed EU inspection certification for clinical supply manufacturing for vaccine products in the EU.

• Led the day-to-day operations of a 160,000 sq.ft. Biologics Pilot Plant in West Point, PA. Started up new multi-product facility (facility opened in April 2002) including hiring and training staff (hired 25 staff in 24 months), developing business operational and documentation systems, and manufacturing validation lots for equipment qualification.• Led the development of new business processes to run facility including initiation of a Planning and Scheduling Tool, development of formalized roles/responsibility matrices with BPR&D and support groups, and development of campaign planning alignment approaches.• Developed capital plans for facility expansion and biological clinical supply capacity planning.• Created long range operational and capital plans, annual profit plans, and pipeline flow assumptions for all departments in BPR&D.

• Project Manager for vaccine and drug development programs including Pneumovax23, Pneumococcal - Meningococcal Conjugate vaccine, MK-0869-CINV (assistant Manager), and M-M-RII. Responsible for coordination or resource planning and requests, development and maintenance of program timelines, creation and management of subteams, ensure identification and resolution of program issues, and provide overall administrative function (agendas, minutes, tracking sheets) for project teams and subteams.• Led project management due diligence activities for new licensing candidates for vaccines.• Led the creation of business models for vaccines: CMC preparation and review process, Business Valuations (NPV), and JV Product Offers.• With Executive Director of Vaccine Integration, designed and recruited staff for a new clinical development group focused on early vaccine clinical development activities. Led clinical operations activities for group including interfacing with external partners.

Phd, Chemical And Biochemical Engineering

Masters - Internship, Biotechnology

Research Advisor: Dr. Peter Brodelius

Bche, Chemical And Biochemical Engineering