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Robert J Steininger II
Description:
Robert J. Steininger II 100 Reed Street Cambridge, MA 02140-1740 Cell 617-449-XXXX home 617-868-XXXX (email: XXXX@alum.mit.edu)SUMMARY: Consultant, senior executive, process engineer, and manager with extensive experience in the process development and project management for pharmaceuticals using biotechnology. Established and managed a variety of projects, leading to product candidates and commercially approved biopharmaceuticals. Particular strengths are in the following areas:• Process Development • CMC Regulatory filings • Project Management • Design of Pharmaceutical Production facilities • Team Building • New Technology Development and Transfer EXPERIENCE Consultant 7/21 - Surface Oncology Senior VP, CMC 5/18 – 7/21Manage the personnel focused on Quality and the process development for and the production of clinical material, which is made at numerous CMOs in five different countries. Work as part of NSF team evaluating progress related to cell and gene therapy. Voyager Therapeutics 10/15 - 4/18 Director, Manufacturing Operations (was consultant for first year) Until a CTO was hired, managed personnel focused on process development and analytical developmentQC at Voyager, including writing first IND and the design of a phase III process for the most advanced product. Assisted in the development of multiple processes and managed the transfer of three processes to CMOs tomake gene therapy products based on AAV virus production using multiple cell lines. Set up contracts with CMOs for the production of clinical trial material. Did formulation development work in lab for AAV products. Acceleron Pharmaceuticals 3/07 – 8/14 Senior VP of Manufacturing and Process Development Responsible for the development of processes, and the characterization and production of drug substance and drug product. Managed validation, process engineering, quality control (until 2009), supply operations, Process Development, Analytical Development, and Manufacturing. Coordinated the CMC Regulatory filings (until 2009) for the production of fusion proteins used in phase 1 and phase 2 clinical trials. Designed and managed the construction of Acceleron’s second production facility based on single use equipment. Managed the CMC interactions with Celgene. Helped transfer the process developed by Acceleron to their CMO in Singapore. The product, REBLOZYL® (luspatercept-aamt), was approved in the United States in 2019. Millennium Pharmaceuticals, Inc. 2/00 – 3/07 Vice President, BioProcess Development 10/06 - 3/07 Responsible for drug substance, drug product, analytical development, and outsourcing for the protein development projects at Millennium. Vice President, Process Sciences ` 12/04 - 10/06 Responsible for managing the chemists and chemical engineers developing the processes for the bulk production of both large and small molecule clinical drug candidates. Vice President, R & D Strategy and Operations 12/03 – 12/04 Directed company wide effort to collect financial and staffing information on all development projects in a common format for senior management, including the Board of Directors. Managed the individuals responsible for the systems and tools to provide the data used in portfolio evaluation and balancing personnel and finances of projects. Served as internal consultant on protein-based development projects. Responsible for shaping the long-term strategy for the development of protein products.Senior Director, Project Management, Operations 1/03 – 12/03 Program leader for the biotherapeutic products within MPI, including MLN2704, an antibody-drug conjugate drug, and MLN002, a MAb against the T-cell integrin α4β7 (first approved biopharmaceutical for MPI in 2014). Project leader of 1202, a MAb against CCR2 having the potential to be a drug used for multiple inflammation indications (product is still being pursued by Takeda). Senior Director, Protein Sciences 1/00 – 12/02 Responsible for 60 molecular biologists, cell biologists, and protein chemists who expressed, purified, and characterized the proteins required for high throughput screening and pre-clinical biology experiments. Proteins were expressed using insect, mammalian, yeast, and E. coli expression systems. Part of this group developed the cell lines and purification processes for the clinical production of Monoclonal antibodies and conjugated antibodies. Genetics Institute 1/84 – 12/99 Senior Director, DiscoverEase Production 2/97 – 12/99 Responsible for 70 molecular biology and bioinformatics individuals working on Genetics Institute’s commercial genomics project to isolate and sell, non-exclusively, full length secreted human genes and the proteins for which they code. Director, Regulatory Affairs, CMC, Facilities and Operations 2/95-2/97 Responsible for the content and strategy for all submissions related to Genetics Institute’s CMC submissions and Production facilities, including all ELA updates and presentations to the FDA. As head of the operation function, was responsible for the scheduling and completion of all major submissions to regulatory authorities. During 1996, developed and managed the process to submit Genetics Institute’s first two BLA filings, for FIX and IL-11. The latter was a completely electronic submission for which I was responsible for implementing the strategy for creating the electronic text and figures. Director, Biopharmaceutical Operations Leadership Directive 9/94-2/95 Served as facilitator for Genetics Institute’s effort to re-engineer the processes to make drug substance and drug products. Director, Manufacturing Expansion Project 12/93-9/94 Coordinated the planning effort for increasing manufacturing capacity for Genetics Institute. The effort was a three phase project, the first two focusing on creating additional capacity within the present buildings ($15MM). The third phase ($45MM) was for the design and construction of new buildings that would house additional production areas, warehouse, QC laboratory space, support offices, and production utilities. The first two phases were completed. The third phase was put on hold.Director of Production Technology and Engineering 6/92-12/92 Responsible for the development and validation of Phase III processes for protein and drug delivery systems as well as the validation of process equipment and process systems. Managed four departments: Process Engineering; Process Technology and Validation; Systems Calibration and Automation (including equipment validation); and Special Projects Director (Manager, Process Eng) of Process Technology 1/84-6/92 Responsible for large scale process development in fermentation and purification and Phase I Manufacturing of bulk clinical trial material. Managed four departments: Clinical Manufacturing; Process Engineering; Process Technology Laboratory; and Special Projects (Pilot Plant). Functioned as Project Leader for development on numerous projects: bio-erodible particle delivery system, 5/92-8/93; M-CSF, 5/89-5/92; nPA, 1/89-5-89 (responsible for transferring process to both Japanese and US clients); Factor VIII, 10/87-7/88; IL-3, 6/87-1/88; GM-CSF, 4/86-5/87. Was co-production Manager of the Cambridge facility from 9/88 through 3/89. Stone and Webster Engineering Corporation Engineer 9/80-12/84 Served as process engineer and participated in projects dealing with the conversion of numerous fuels (e.g. heavy residue, coal, wood, biomass) to gas and/or liquid products. EDUCATIONUniversity of California, Berkeley MSChE 1979 Massachusetts Institute of Technology SB Chemistry, 1976, Phi Beta Kapp
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April 25 on BarefootStudent
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