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Greg Sears is a Department Head at Lonza Cell & Gene Therapy at Lonza Cell and Gene Therapy. He possess expertise in validation, gmp, biopharmaceuticals, process validation, biotechnology and 12 more skills.
Lonza Cell And Gene Therapy
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Head Of Msat And Process Validation (Gene Therapies)Lonza Cell And Gene Therapy Jul 2021 - PresentDirect a team of up to thirty-five (35) engineers to accomplish successful technology transfers; clinical and commercial production; APS; Process Validations; and all ancillary activities related to MSAT.Create and manage departmental budgets.Drive improvements at all levels of organization and indirectly influence improvements cross-functionally to improve success rates, reduce quality issues, improve safety, and enhance the bottom line.
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Global Director, Msat - Process Validation (Biologics)Thermo Fisher Scientific Jun 2020 - Jan 2021Waltham, Ma, UsInfluence leaders across global biologics network to successfully execute projectsEnsure successful licensure by health authorities across all jurisdictions for strategic projects (100% success rate)Work with matrix teams (no direct authority) to successfully drive network-wide implementation of a holistic process validation program from Stage I through Stage IIIb and decommissioning.Work with sponsor companies to author / co-author CMC filings for various world-wide regulatory agencies and defend policies and practices in regulatory inspections; ensure clientele understand and embrace TFS PV policies as sufficient and robust to bring projects through lifecycle. -
Director, Msat And Process Validation (Biologics)Thermo Fisher Scientific Nov 2018 - Jun 2020Waltham, Ma, UsDirect up to thirty (30) full-time staff and contract personnel to ensure success technology transfers and process validations for biologics (mab) BDS.Create, monitor, and utilize correct leading and lagging KPICascade KPI and targets throughout organizational departments; create and execute project plans for the improvement of KPI.Use KPI to identify improvement needs and create corrective actions.Drive lean transformational actions (kaizen, 80/20, gemba, JDI, 6s).Cross-directional communication between site leadership and directed staff to ensure adherence to leadership intent.Utilization and analysis of disparate and complex data to identify root causes of process failuresCreate corrective and preventive actions for remediation and prevention from the root causes identifiedInitiate proactive error prevention activities and right first time initiatives to create higher likelihood of production successes.
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Site Head Of QualityThermo Fisher Scientific Jul 2017 - Nov 2018Waltham, Ma, UsDirect multiple Associate Directors for a one-hundred thirty-five (135) person Quality unit to ensure full regulatory compliance and production quality while identifying and driving the execution of improvement projects for delivery at the site.Departments included Operations, Systems, Statistics/ Engineering, and Quality Control Chemistry/ Quality Control Microbiology
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Sr. Manager Of Quality - OperationsThermo Fisher Scientific Jan 2016 - Jul 2017Waltham, Ma, Us
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Process Validation ManagerThermo Fisher Scientific Nov 2014 - Jan 2016Waltham, Ma, Us
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Associate Director Of ValidationLonza Biologics Mar 2006 - Oct 2014Various individual contributor and leadership roles from Engineer to Associate Director in equipment, computer systems, and process validation. Created and ran the first comprehensive process validation program, at Lonza and became de facto Lonza Biologics global leader of process validation. Presented to FDA on the implementation of statistics into process validation after the 2011 update the FDA's guidance on process validation. The only CMO representative asked to participate in EMA's updates to Annex 15 (of sixty-one industry contributors)
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Various Individual Contributor Engineering RolesMultiple (Biologics) Jun 1996 - Mar 2006
Greg Sears Skills
Greg Sears Education Details
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University Of Massachusetts AmherstChemistry
Frequently Asked Questions about Greg Sears
What company does Greg Sears work for?
Greg Sears works for Lonza Cell And Gene Therapy
What is Greg Sears's role at the current company?
Greg Sears's current role is Department Head at Lonza Cell & Gene Therapy.
What is Greg Sears's email address?
Greg Sears's email address is gr****@****her.com
What is Greg Sears's direct phone number?
Greg Sears's direct phone number is (919) 226*****
What schools did Greg Sears attend?
Greg Sears attended University Of Massachusetts Amherst.
What skills is Greg Sears known for?
Greg Sears has skills like Validation, Gmp, Biopharmaceuticals, Process Validation, Biotechnology, Computer System Validation, Change Control, Fda, Sop, Pharmaceutical Industry, Cleaning Validation, 21 Cfr Part 11.
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