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A focused and top-performing leader with extensive experience in cGMP, Lean, batch, and continuous process manufacturing, as well as process safety, project/change management, multi-site operations, budgeting, technical supervision, quality control, quality assurance, regulatory compliance, consulting, client relations, and turnaround strategies. Leverages practical experience with strong technical abilities to gain understanding of new technologies and excel in fast-paced environments. A resourceful producer and team builder who possesses a proven track record of delivering profitable manufacturing strategies in challenging environments.
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Head Of Global Manufacturing OperationsAdesis, Inc. Jun 2024 - PresentNew Castle, De, UsLead the Global Adesis manufacturing and quality organization to support manufacture of organic light-emitting diodes (OLEDs) and materials to the pharmaceutical and specialty chemical industries. -
Head Of Quality & Continuous ImprovementAdesis, Inc. Nov 2022 - Jun 2024New Castle, De, UsResponsible for the development and execution of the Adesis Quality Management System (QMS) and Continuous Improvement Program. -
Head Of ManufacturingAdesis, Inc. Mar 2021 - Nov 2022New Castle, De, UsEstablish the Adesis manufacturing organization to produce intermediates used in organic light-emitting diode (OLED) devices, and a contract manufacturing & development organization (CDMO) providing materials to the pharmaceutical and specialty chemical industries. -
Director Of OperationsSiegfried Holding Ag Jan 2020 - Mar 2021Zofingen, Aargau, ChResponsible for the overall manufacturing operations of Active Pharmaceutical Ingredients (APIs) and drug product intermediates at the Pennsville facility, including Chemical Operations, Physical Operations (drying, milling & blending), Process Engineering and Supply Chain activities (planning, warehousing, and distribution). -
Operations ManagerMerck Jun 2018 - Jan 2020Manage upstream and downstream manufacturing operations for five reassortants of bulk rotavirus. Collaborate with Planning, Quality, Technology, and Maintenance groups to ensure on time in full release of all bulk reassortant viral fluids to support RotaTeq® manufacture. Ensure sterile supply for aseptic manufacturing, including machine preparation, sterilization, and decontamination, as well as maintaining Grade ABCD processing cleanrooms. Lead safety and gemba walks to ensure compliance to cGMP and applicable safety regulations, to drive culture of continuous improvement.
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Director Of OperationsBionique Testing Laboratories, Inc. Jan 2018 - Mar 2018Saranac Lake, Ny, UsManaged daily operations of a GMP mycoplasma and cell culture testing laboratory, including media manufacturing, and facilities management. -
Chemical Operations ManagerMallinckrodt Pharmaceuticals Aug 2015 - Sep 2017Dublin, Ireland, IeManaged two active pharmaceutical ingredient (API) intermediate production units. Ensured compliance to OSHA 1910.119, Process Safety Management (PSM). Collaborated with planning and customer service to meet short/long-term production schedules. Employed Lean principles to maintain equipment and facilities in audit-ready condition. Partnered with quality assurance to elevate level of cGMP compliance; developed systems to improve investigations into process deviations and out of specification (OOS) results. Helped set strategic direction of facility as member of the site leadership team. -
Operations ManagerPfanstiehl, Inc. Sep 2014 - Aug 2015Waukegan, Il, UsManaged parenteral grade excipient and high potency API (HPAPI) production units operating 24/5. Worked with planning and supervisory staff in executing production plans to meet delivery requirements. Partnered with quality control/assurance in achieving timely completion of product testing and manufacturing records to support ongoing production and product release. Managed 30 bargaining unit employees, serving as management contact in resolving grievances. -
Site DirectorSigma-Aldrich Apr 2012 - Sep 2014St. Louis, Mo, UsEntrusted with P&L responsibility for three manufacturing sites located in St. Louis and Cleveland, including two biopharmaceutical raw material sites, and one diagnostic tableting facility. Provided direct leadership for manufacturing, engineering, maintenance, R&D, and supply chain/logistics activities. Analyzed manufacturing capabilities, demands, and cost structures across portfolio of over 500 products to make strategic recommendations on insourcing, outsourcing, and capital improvements. Partnered with corporate EHS and engineering to remediate compliance issues found during acquisition due diligence. Managed relationships with strategic customers to improve company value proposition. -
Manager, Manufacturing & Corporate Asset UtilizationSigma-Aldrich Jan 2010 - Apr 2012St. Louis, Mo, UsServed in leadership role for 24/7, PSM-regulated manufacturing facility with portfolio of over 200 products and generating over $43,000,000 in annual sales. Fulfilled customer demand by scheduling production, securing raw materials, and controlling quality. Allocated $6,000,000 operating and $2,000,000 capital budgets. Analyzed manufacturing capabilities, demand, and costs across product portfolio. Managed large-scale production through supervisory teams. Directed efforts of small R&D group to develop new and optimize existing products through lab and pilot-scale activities. Led sales and operations planning team to balance short-/long-term capabilities. Interacted with customers to resolve product/supply concerns and identify new products and improved processes. -
Quality Control ManagerSigma-Aldrich Apr 2006 - Jan 2010St. Louis, Mo, UsDirected quality control for laboratory supporting three API manufacturing facilities - one synthetic, one biologic, and one producing clinical scale antibody drug conjugates (ADC) - producing 75 cGMP products, including seven commercial APIs. Led 35-member team charged with completing analytical testing of raw materials, intermediates, and finished products, including microbiology/cell culture performance testing, as well as managing the API stability program for all three units. Participated in and responded to customer audits, and two FDA audits. Served on site material review board (MRB). -
Production SupervisorSigma-Aldrich Mar 2005 - Apr 2006St. Louis, Mo, UsWorked as first-shift supervisor for API facility manufacturing 40 products, including seven commercial APIs generating $8,000,000 in sales. Directed shift chemist and four operators in daily manufacturing activities, as well as two process chemists dedicated to supporting technology transfers from process development activities. Oversaw documentation review to ensure timely product releases or campaign initiations. Represented department in corporate process improvement forum. -
Management ConsultantDewolff Boberg & Assoc Jan 2004 - Feb 2005Introduced effective performance and culture change management projects to private and public-sector clients. Collaborated across teams to assess prospective client needs, quantify operational problems, and present recommendations to senior management. Executed projects that captured over $13,000,000 in client savings. Developed reputation as expert analyst by business development team for ability to identify/articulate opportunities found during customer analysis engagements, leading to highest conversion rate among analysts during tenure. -
Production ManagerAsh Stevens Llc, A Subsidiary Of Piramal Pharma Solutions Aug 1999 - Nov 2003Lexington, Ky, UsManaged daily activities for production of six commercial, high potency, cytotoxic, and/or non-hazardous APIs at both kilo-lab and reactor-scale. Oversaw warehouse and shipping/receiving department, ensuring all shipments complied with cGMP and DOT regulations. Managed front-office staff, including accounts payable, administration, IT, and assisted with local site HR. Interacted with customers to plan and schedule production as well as coordinate tech transfer and scale-up activities with process development. -
Process ChemistAsh Stevens Llc, A Subsidiary Of Piramal Pharma Solutions May 1997 - Aug 1999Lexington, Ky, UsSynthesized APIs and intermediates for clinical trials and commercial distribution. Served as transfer chemist from process development to manufacturing scale. Maintained proper documentation and execution of documents to ensure timely release of intermediates and final APIs. Served as first-level support for IT issues.
David Baran Skills
David Baran Education Details
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Lawrence Technological UniversityIndustrial Operations Management -
Eastern Michigan UniversityChemistry
Frequently Asked Questions about David Baran
What company does David Baran work for?
David Baran works for Adesis, Inc.
What is David Baran's role at the current company?
David Baran's current role is Manufacturing Professional.
What is David Baran's email address?
David Baran's email address is db****@****inc.com
What is David Baran's direct phone number?
David Baran's direct phone number is +184762*****
What schools did David Baran attend?
David Baran attended Lawrence Technological University, Eastern Michigan University.
What are some of David Baran's interests?
David Baran has interest in Education.
What skills is David Baran known for?
David Baran has skills like Gmp, Fda, Technology Transfer, Lean Manufacturing, Site Management, Cross Functional Team Leadership, Operations Management, Change Management, Active Pharmaceutical Ingredients, Contract Manufacturing, Process Safety Management, Quality Control.
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