Luis Lima Email and Phone Number
Luis Lima is a Associate Director, Manufacturing Support at PTC Therapeutics, Inc..
Ptc Therapeutics, Inc.
View- Website:
- ptcbio.com
- Employees:
- 965
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Associate Director, Manufacturing Support (Ms&T Equivalent)Ptc Therapeutics, Inc. Mar 2020 - PresentHopewell, New Jersey, United StatesLead a team of Tech Transfer Leads and Engineers responsible for the Technical Transfer Activities of early phase molecules from Process Development to the Clinical Manufacturing spaceImplement, adhere, and achieve project goals throughout proactive Project Management, Process Modeling, Raw Material projection planning, Scale up and Tech Transfers of assets into the GMP Clinical Manufacturing SpaceTechnology Transfer Team Lead • Oversee planning and execution of manufacturing Tech Transfer projects from early process development to full-scale GMP manufacturing (Downstream and Upstream)• Actively engage in cross-functional relationships to facilitate project planning and project execution• Assure end to end project scope transparency- from project planning to project monitoring and closure• Support CMC authorship, IND applications and amendments• Apply effective risk assessment process to evaluate batch to batch performance, monitor and trend data for detection of potential nonconformities• Provide end -to -end manufacturing process expertise (from Process Development to full scale manufacturing of the final product) to ensure compliance standards are met Global Deviation Investigation Program Lead• Successfully identify project risks and develop mitigation strategies to minimize and monitor product/process impact• Responsible for establishing Risk Assessment, Root Cause Analysis, Product Impact Assessment, • Global Deviation Investigation Program Coach for the Manufacturing and Analytical Department Lead Investigators and Quality Lead Coordinators• Oversee process and product related change controls• Represent the Hopewell Clinical Manufacturing space during Global Quality Audits• Provide support with Health Authorities requests• Supported start up activities for building the HPW manufacturing model from design to production• Led validation activities for the GMP Manufacturing suite to assure site readiness and adherence to quality requirements -
Senior EngineerBristol Myers Squibb Jan 2015 - Feb 2020Hopewell, New Jersey, United States• Technical Transfer Lead (transfer strategy and critical timelines) for multiple project specific processes (NKG2A, IL2-CD25, aOX40, aCD27, Glypican-3 mAb, Abatacept New Generation Process, aIL-7R, aMICA, CTLA4NF Probody, aCD30NF, CD-3 BCMA) from Process Development to Hopewell Clinical Manufacturing (HCM) • Provided CMC support for IND filing documents from manufacturing process perspective • Matrix leader for Upstream and Downstream technology transfers; managed and supported planning, execution, and monitoring of the technology/outsourcing transfers• Collaborated and effectively communicated/engaged in proactive liaisons with strategic stakeholders within and outside BMS (BDQO, BD-MAD, PD, MS&T, DPST, IDT, GP; selected external partners)• Delivered expert guidance to establish manufacturing viability, efficiency and quality during the technology transfer process; ensured project adherence to the tech transfer procedures and assured process improvements where needed• Represented the entire clinical manufacturing function in the CMC team; partnered with representatives from key functional departments such as Process Development, Formulation Development, Quality, Regulatory, Manufacturing, Supply Chain, Global Procurement, CROs• Provided leadership for further improvement of technology tools utilized to assist in developing, assigning, tracking and analyzing workloads • Conducted meetings to understand planning, compliance needs, provided support to manufacturing processes (raw material group, daily operational meetings, sample plan review meetings, CMC meetings)• Led investigations to support Quality Assurance/Quality Control compliance for Deviation Investigations, Risk Assessments, Root Cause Analysis, Product Impact assessment within HCM
Luis Lima Education Details
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Engineering Management -
Nuclear Energy Engineering Technology
Frequently Asked Questions about Luis Lima
What company does Luis Lima work for?
Luis Lima works for Ptc Therapeutics, Inc.
What is Luis Lima's role at the current company?
Luis Lima's current role is Associate Director, Manufacturing Support.
What schools did Luis Lima attend?
Luis Lima attended Penn State University, Thomas Edison State University.
Who are Luis Lima's colleagues?
Luis Lima's colleagues are Denise Mcnairn, Janki Patel, Jaden Visaya, Michael Dooley, Julie Lavillaureix, Joann Palmieri, Catarina Madanêlo.
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