Maria Wik Email and Phone Number
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Technical Leader with 20+ Years in CMC Pharma Development With over 20 years in the pharmaceutical industry, I specialize in leading teams through the complexities of CMC activities during early-stage drug development through commercial supply. I’ve been involved with projects starting from cell line development and process development to technology transfer and scaling up for clinical and commercial supply. My experience spans both Drug Substance and Drug Product.I’ve held leadership roles across Process Development, MSAT, and Manufacturing, working closely with cross-functional teams to ensure the seamless transition from early-stage development through to clinical and commercial production. My experience includes working with both microbial and mammalian systems, leveraging both single-use technologies and traditional stainless-steel equipment to optimize processes and ensure that we meet regulatory and quality standards for early-phase clinical trials through commercial supply.I’m known for being proactive, organized, and able to see ahead to prevent issues before they become problems—traits that have helped me build strong teams and deliver results.Key Areas of Expertise:• Phase 1 through Commercial supply• CMC Strategy & Execution• Technology Transfer & Process Scale-up• cGMP, Clinical & Commercial Production• Process Characterization & Validation• Regulatory Inspections & Filings• Microbial & Mammalian Processes• Multi-host & Multi-product FacilitiesI’m passionate about what I do and love being part of a team that’s working to bring life-changing medicines to patients.
Rmc Pharmaceutical Solutions
View- Website:
- rmcpharma.com
- Employees:
- 11
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Rmc Pharmaceutical SolutionsBoulder, Co, Us
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Vice President CmcSyner-G Biopharma Group Jan 2023 - PresentFramingham, Ma, Us -
Vice President Technical Operations | Sr ConsultantRmc Pharmaceutical Solutions Aug 2021 - Jan 2023Longmont, Co, UsDevelop new and existing client interactions to enhance technical project efficiency and outputs. Evaluate and expand technical resources and systems to support client needs. Provide full-range CMC assistance to clients in biopharmaceutical industry.
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Sr Director, Head Of Manufacturing ColoradoNovartis Gene Therapies Apr 2019 - Jul 2021Basel, Baselstadt, ChMember of Site Leadership Team. Established and lead the Manufacturing team through site start-up, enabling of manufacturing capabilities in the facility, and successful execution of Process Qualification and Commercial Manufacturing batches. • Hired and trained a highly skilled team of 130 Manufacturing staff• Provided Manufacturing oversight of project to retrofit facility, purchase process equipment, and qualification of facility and equipment• Started GMP production within 10 months of site purchase• During COVID... delivered 100% success rate on 100+ batches within first year of production• Successfully increased production rate by 300% in 1st year of production -
Director Ms&TAstrazeneca Dec 2017 - Mar 2019Cambridge, Cambridgeshire, GbMember of the site leadership team. Hired a team of 220+ staff at the site, supported capital project to retrofit the facility, started-up and qualified facility, and delivered successful execution of tech transfer and process performance qualification (PPQ) batches of internal product. The experience of hiring and developing a high performing organization from scratch for an entire site was an incredibly rewarding experience and I was challenged to grow and stretch as a leader.• Technology Transfer that resulted in Process Performance Qualification Runs with 100% success rates and no failed Process Validation parameters -
Associate Director Ms&TMedimmune Mar 2016 - Dec 2017Gaithersburg, Maryland, UsEstablished and lead MS&T group supporting facility start-up and tech transfer of internal products. -
Senior ConsultantRmc Pharmaceutical Solutions Feb 2015 - Feb 2016Longmont, Co, UsProvided Chemistry, Manufacturing and Controls (CMC) expertise to small and virtual biotechnology companies to help them advance their programs towards commercial products. Supported Drug Substance and Drug Product projects. International client basis. The opportunity to work with small companies and earlier stage commercialization than I had previously supported, offered me a different perspective on risk taking and challenged me to develop a more entrepreneurial mindset. • Technology Transfer lead on behalf of clients transferring to a CMO• Led planning and execution of viral clearance studies; coordinating between client's CMO and contract viral clearance lab• Feasibility evaluations for using cGMP facilities for multiple cell lines and product types
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Senior Manager ManufacturingAmgen 2012 - 2015Thousand Oaks, Ca, Us• Member of Plant Leadership operating a 160,000 square foot multi-host cGMP facility• Led team of seven technical specialists responsible for product lifecycle management of five products• Product campaigns started on target schedule, had a 100% success rate, and delivered up to 25% yield increase compared to prior campaigns• Worked to advance Operational Excellence within facility, leading to qualification of plant in Amgen’s initial stages of lean six sigma -
Process Development Facility Lead, Principal Engineer, Process DevelopmentAmgen 2010 - 2012Thousand Oaks, Ca, Us• Single point of contact to Plant Manager for Process Development support in multi-product/multi-host facility • Provided technical oversight and managed team of 10 Process Development staff that supported clinical and commercial production of three products. All campaigns had a 95%+ success rate, were within yield targets and dispositioned on-time• Supported multiple inspections (FDA, EMEA, ANVISA, Turkey MOH)
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Technology Transfer Lead, Principal Engineer, Process DevelopmentAmgen 2009 - 2010Thousand Oaks, Ca, Us• Led Technology Transfer of large-scale microbial process into a commercial multi-host facility • Drove process design decision that delivered required product throughput with reduced operational risk, leading to successful first engineering run which generated material for comparability studies two months ahead of schedule• Implemented a 5-fold process scale-up that achieved 100% success rate during production runs • Received company Operational Excellence award for successful refold process scale-up to an unprecedented scale
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Senior Engineer, Process DevelopmentAmgen 2005 - 2009Thousand Oaks, Ca, Us• Executed Technology Transfer for upstream process into commercial facility • Organized and executed process characterization of harvest steps at pilot scale• Developed equipment design requirements that resulted in equipment fit for use• Provided technical support during engineering and commercial runs• Authored Process Description section of Marketing Application
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Engineer, Process DevelopmentAmgen 2002 - 2005Thousand Oaks, Ca, Us• Provided commercial support for large-scale mammalian process• Evaluated impact from process excursions• Provided detailed review and approval of Manufacturing Procedures and Process Validation documents
Maria Wik Skills
Maria Wik Education Details
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University Of Colorado BoulderChemical Engineering -
Hogskolan Dalarna, SwedenAnalytical Chemistry
Frequently Asked Questions about Maria Wik
What company does Maria Wik work for?
Maria Wik works for Rmc Pharmaceutical Solutions
What is Maria Wik's role at the current company?
Maria Wik's current role is CMC expert | VP Technical Operations.
What is Maria Wik's email address?
Maria Wik's email address is ma****@****inc.com
What is Maria Wik's direct phone number?
Maria Wik's direct phone number is +130324*****
What schools did Maria Wik attend?
Maria Wik attended University Of Colorado Boulder, Hogskolan Dalarna, Sweden.
What skills is Maria Wik known for?
Maria Wik has skills like Biopharmaceuticals, Biotechnology, Technology Transfer, Gmp, Validation, Fda, Process Simulation, Fermentation, V&v, Purification, Commercialization, Aseptic Processing.
Who are Maria Wik's colleagues?
Maria Wik's colleagues are Amy Slaymaker, Sheri Glaub, Emily Stites, Rehan Ud Din, Duane Bonam.
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