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Melanie Herrmann, Ms, Pmp personal email
• Program Management professional with 18+ years of international experience in the biopharmaceutical industry, specializing in CMC, strategic business development and Alliance management roles spanning microbial, mammalian, RNA therapeutics, autologous and allogeneic cell therapy products from pre-clinical through commercial stage. Driven by a strong passion for science, technology, and sustainability, striving to add and integrate new modalities in the RNA therapeutics and cell and gene therapy space. • Demonstrated ability to successfully build and lead cross functional teams, programs and projects with strong technical and business qualifications in: technology transfers, contract manufacturing operations, vendor management, Alliance management, business development including long range planning, commercialization process, process improvement, clinical and commercial manufacturing operations, recruiting/retaining high quality PMs.
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Cmc ConsultantAvidity Biosciences, Inc. Apr 2023 - PresentSan Diego, California, Us -
Senior Director, Program Management - Tech OpsInstil Bio Mar 2022 - Oct 2022• Served as the Head of Tech Ops Program Management responsible for ensuring cross-functional operational readiness to enable clinical studies of tumor-infiltrating lymphocyte (TIL) cell therapy products. Scope of Program Management activities included GMP operational readiness of global facilities (US, UK), EMPQ, Tech Transfer, CMC Module 3 deliverable readiness (IND and pivotal stage), and external manufacturing for plasmid and LVV suppliers. • Provided program management leadership and facilitation for cross-functional Tech Ops/Clin Ops senior leadership team/meetings.• Established, implemented and ensured effective change management for several key department processes/initiatives including internal governance structure, external manufacturing engagement model, risk management plan including risk register, dashboards, Lessons Learned/After Action review methodology, decision making model, PM tools and templates.• Recruited, trained, and mentored 3 program managers supporting Tech Ops. -
Director Program Management - Tech OpsInstil Bio Aug 2020 - Feb 2022
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Associate Director, Cmc Program ManagementKite Pharma Apr 2018 - Aug 2020Santa Monica, California, Us• Served as cross-functional technical operations team program manager for pre-IND stage allogeneic CAR T-cell therapy program. • Developed integrated cross-functional project plans, timelines, risk register, monthly reports and managed/tracked activities. Developed CMC commercialization road map with phase gates and change management plans.• Worked with Operations Team lead, Tech Ops leadership and external Alliance partners to develop and refine operations strategies pertaining to AAV and ZFN mRNA supply.• Provided program management leadership and facilitation for internal and external project team meetings and communicated updates to executive management.• Recruited, trained, and mentored 1 program manager. -
Associate Director, Cmc Project Leader BiologicsBoehringer Ingelheim Feb 2017 - Apr 2018Ingelheim Am Rhein, Rhineland-Palatinate, De• Led global team of subject matter experts across various disciplines/functions for post-launch monoclonal antibody tech transfer of KEYTRUDA®. Scope spanned cell banking through BDS disposition, including facility expansion in the contract manufacturing business.• Oversaw setting and achieving of project goals, including timelines, budget, and scope. • Acted as the primary contact person for the clients, coordinated the flow of information to/from the client and communicated to the steering committee. -
VolunteerRoze Room Hospice Oct 2016 - Feb 2017Los Angeles, Ca, Us -
Senior Manager, Operations Strategic Planning And RiskAmgen Inc Sep 2015 - Oct 2016Thousand Oaks, Ca, Us• Advised leaders in strategic, mission-critical issues to generate, capture and preserve value across the Operations network. Led cross functional team to assess business development opportunities for operations specific aspects.• Planned Drug Substance network strategy, commercial manufacturing site selections and long range planning capacity/utilization modeling. Spearheaded next generation biomanufacturing facility master planning and implementation of new technologies. -
Contract Manufacturing Senior ManagerAmgen Inc Mar 2013 - Sep 2015Thousand Oaks, Ca, Us• Managed external Contract Manufacturing site and led Amgen’s cross functional team for Blincyto® (blinatumomab) Drug Substance, a bispecific CD19-directed CD3 T-cell engager (BiTE®), from Phase I CTM through launch as a Project Lead and Project Manager. • Led cross-functional teams (Quality, Process Development, Analytical Sciences, Supply Chain) with clear accountability for performance, ensuring the quality, supply and cost of product are consistently met and communicated updates to executive management and steering committees. • Managed budget development, monitoring and reporting, POs and invoice payments, and ensured cost of production targets are met. Negotiated supply agreements, commercial agreements, and amendments.
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Contract Manufacturing ManagerAmgen Research Munich (Formerly Micromet) Mar 2012 - Mar 2013
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Senior Project Manager CmcMicromet Jan 2011 - Mar 2012Us• Managed the end to end supply chain from cell banking through drug substance manufacturing, drug product fill/finish and distribution of biopharmaceuticals at Micromet. -
Process Engineering Specialist-Tech Transfer FermentationBoehringer Ingelheim Rcv Mar 2006 - Jan 2011Ingelheim Am Rhein, Rhineland-Palatinate, De• Led the Tech Transfer team and Process Validation team for contract manufacturing microbial fermentation processes (200 L – 4,500 L scale) of 11 products for international clients ensuring clinical and commercial supply.• Served as key contact for customer tech transfer counterparts via e-mail, presentations during face-to-face Joint Project Team meetings and phone- and video conferences.• Compiled master batch records, SOPs, technical protocols and reports, sampling plans, FMEAs, process validation and comparability documentation, filing documentation. Facilitated operator training on manufacturing processes, escorted customer Person in the Plant and customer auditors.
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ScientistResearch Centre Applied Biocatalysis Jun 2005 - Feb 2006Fermentation and application of enzymes for synthetic polymer surface modification
Melanie Herrmann, Ms, Pmp Skills
Melanie Herrmann, Ms, Pmp Education Details
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University Of GrazMicrobiology
Frequently Asked Questions about Melanie Herrmann, Ms, Pmp
What company does Melanie Herrmann, Ms, Pmp work for?
Melanie Herrmann, Ms, Pmp works for Avidity Biosciences, Inc.
What is Melanie Herrmann, Ms, Pmp's role at the current company?
Melanie Herrmann, Ms, Pmp's current role is CMC Consultant.
What is Melanie Herrmann, Ms, Pmp's email address?
Melanie Herrmann, Ms, Pmp's email address is me****@****bio.com
What schools did Melanie Herrmann, Ms, Pmp attend?
Melanie Herrmann, Ms, Pmp attended University Of Graz.
What are some of Melanie Herrmann, Ms, Pmp's interests?
Melanie Herrmann, Ms, Pmp has interest in Travelling, Ornithology, Sports.
What skills is Melanie Herrmann, Ms, Pmp known for?
Melanie Herrmann, Ms, Pmp has skills like Biotechnology, Technology Transfer, Biopharmaceuticals, Pharmaceutical Industry, Gmp, Fermentation, Microbiology, Life Sciences, Contract Manufacturing, Process Engineering, Fda, Validation.
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