Mark King Email & Phone Number

Saint Paul, Mn, Us

Roseville, Minnesota, United States

No change in my position - Rebiotix has now been fully integrated into Ferring and rebranded as Ferring Microbiome Inc.

Greater Minneapolis-St. Paul Area

Saint Paul, Mn

Early stage biologics development expert in process development, phase-appropriate Quality systems, and CMC regulatory submissions.▪ Over 25 years in biotech industry developing biologics – experience in proteins, peptides, plasmids, carbohydrates derived from biotechnology and blood-products▪ Wide range of experience in development – fermentation, purification, formulation, assay development – including ICH Q8 guidelines▪ Knowledge and experience of GMP▪ Generated numerous CMC packages for INDs and IMPD▪ Interacted extensively with internal and external Regulatory and Quality organizations▪ Established ICH compliant quality system in small scale biopharmaceutical company; transitioned from paper to cloud-based QMS; managed/executed numerous investigations▪ Supervision and management experience of up to 21 staff members in three departments - Process Development, Assay Development, and Formulation

Eagan, Mn

Senior Director of Quality (02/14 – 10/18)• Align Quality departments with ICH guidelines (Q9, Q10)• Instituted quality management review system for executive leadership• Lead the transition from a paper-based to cloud-based quality management system• Investigation of process and product related issues and implementation of solutions• Oversee stability programDirector of CMC Development (10/12 – 02/14)• Develop and maintain a comprehensive risk management plan for CMC program in accordance with current global regulatory requirements. • Direct risk mitigation in the areas of process and assay validation, BLA readiness, CMC planning and data tracking/trending.• Assist in the development of short term and long term CMC planning• Direct development and alignment of regulatory documents from a CMC perspective • Direct stability program plans in conjunction with the quality function

• Directed three groups: Formulation Research, Analytical & Assay Support, and Protein Expressiono Up to 21 staff members (including 6 Ph.D.) to support cancer vaccine (plasmids and peptides) and small molecule oncology programs• Provided biologics process manufacturing expertise for technology assessment of safflower produced insulin and a recombinant insulin production facilityo Reviewed DMFs covering production of insulin• Directed stability program on cancer vaccine components (plasmid DNA and peptides)• Generated CMC sections for four INDs, two with three active components• Primary interface with CMO and CRO to produce clinical products, delivered on-time for delivery to clinical sites• Established Analytical & Assay Support group to assume responsibilities for CMC related assays, Pharm/Tox support assays, and in vitro ADME assays• (Pre-)Formulation development of peptides and proteins for liquid, lyophilized, and Technosphere® particles• Assay development for purity and identity of allergy vaccine products• Developed process for manufacture of allergy vaccine products (bee venom, grass pollen, cat dander)• Generated GMP documentation and systems for allergy vaccine production• Managed preclinical and clinical production of allergy vaccines• Trained staff, setup and running of laboratory• Supervised laboratory staff in assay and process development activities• Investigated process and product deviations for Quality Assurance

• Troubleshoot cGMP protein purification processes• Designed and executed study protocols• Reviewed and approved validation protocols• Optimize processes• Implemented statistical process control program, including writing the SOPs, coordinating the implementation of computerization, training of staff• Investigated process and product deviations for Quality Assurance

• Responsible for the scale-up and transfer of technology to clean room, including writing documentation (batch records, worksheets and SOPs)• Training of production staff on new processes• Supervision of production staff performing new processes• Assisted in the production of the proteins under cGMPs• Member of Purification Process Validation Committee responsible for planning, reviewing, and approving validation protocols and reports• Responsible for the planning and execution of process validation protocols including multivariable methods (DOE) to validate reversed phase chromatography, refolding, and ultrafiltrations• Supervised coworkers performing validation protocols• Wrote SOPs describing assays, equipment, and other methods• Coordinated projects performed with contract laboratories for process validation• Wrote reports documenting validation as part of BLA submission to FDA• Responsible for auxiliary training for cGMP documentationProcess Development and Formulation activities• Responsible for the development and optimization of fermentation and initial processing steps for therapeutic recombinant proteinso Skills included: E. coli fermentation, basic genetic techniques, and initial recovery procedures• Responsible for the development of purification and reactivation stepso Skills included: chromatography (reversed phase, immunoaffinity, hydrophobic interaction, ion exchange), filtration: (buffer exchange, removal of endotoxins), and refolding of proteins• Responsible for the development and evaluation of formulations for lyophilized and frozen storage pharmaceuticals• Developed capillary electrophoresis methods• Developed ELISA protocol to measure therapeutic protein in the presence of neutralizing antibodies

• Directed fermentation laboratory with both research and production goals• Duties included optimizing fermentation conditions for maximum yield of cells and maximum expression of recombinant proteins, supervision of technicians for the production of material for processing, developing process documentation for cGMP• Interacted extensively with downstream processing development in scaling up numerous recombinant processes

M.S., Biochemical Engineering

B.S., Biochemistry