Maria Wik Email & Phone Number

Boulder, CO, US

Framingham, MA, US

Longmont, CO, US

Develop 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.

Basel, Baselstadt, CH

• Member 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.
• 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

Cambridge, Cambridgeshire, GB

• Member 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.
• Technology Transfer that resulted in Process Performance Qualification Runs with 100% success rates and no failed Process Validation parameters

Gaithersburg, Maryland, US

Established and lead MS&T group supporting facility start-up and tech transfer of internal products.

Longmont, CO, US

• Provided 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.
• 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

Thousand 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

Thousand 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.
• Supported multiple inspections (FDA, EMEA, ANVISA, Turkey MOH)

Thousand 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.
• 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

Thousand 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

Thousand 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

M.S., Chemical Engineering

B.S., Chemical Engineering, Analytical Chemistry