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Director, Microbiology and Environmental Monitoring - Hayward

Company: Intarcia Therapeutics, Inc.
Location: Hayward
Posted on: September 15, 2019

Job Description:

Intarcia is rethinking medicine with the potential to unlock significant change in the way serious chronic diseases or conditions are treated - starting first with Type 2 Diabetes, and then, obesity and HIV. To date, the company has raised more than $1.8B in capital through creative financing and partnerships - including our collaboration with the Bill and Melinda Gates Foundation for HIV prevention in Sub-Saharan Africa. Intarcia headquarters are in Boston, MA with manufacturing and R&D locations respectively in Hayward, CA and Durham, NC.Intarcia is committed to developing innovative therapies utilizing the Medici Drug Delivery System which is designed to bridge technology and medicine to transform therapeutic categories. The matchstick-sized osmotic mini-pump is subdermally placed and delivers a continuous flow of medication over the course of months, working with the patient's own body. This approach is designed to support adherence and allow individuals to focus on more fully living their lives.Your Opportunity:As a key member of the Quality Assurance Team, the Director, Microbiology and Environmental Monitoring is responsible for leading, and managing microbiology testing sterility assurance including surveillance of Environmental Monitoring (EM) activities (site and personnel) in accordance with FDA, Intarcia procedures and other global regulations (21CFR4, 210/211, 820, IS0 13485, and ICH Q10). This candidate will have direct oversight for all activities associated with microbiology, sterility assurance, and EM Program including; gowning and gown qualifications, process simulation testing (PST), water sampling, viable and non-viable sampling, management of Intarcia vendors, and generation of quarterly EM reports.Duties and Responsibilities:Oversight of EM program and microbial analysis of utilities (for e.g., water, clean dry air, nitrogen) ensuring compliance with regulatory requirements and Intarcia standard operating procedures.Oversight of Contract Test Laboratories and Service Providers as it relates to microbiology testing sterility assurance, EM activities and regulatory compliance.Schedule, coordinate and oversee all activities related to the EM Program.Review, track and trend EM results and generate quarterly EM reports for Senior Management review.Oversee Intarcia's gowning program including periodic gown qualifications.Act as single point of contact for all EM investigations, out of levels, out of alert/action limits, out of trends, and Corrective and Preventive Actions.Review and approve SOPs, Specifications, PST protocols and reports associated with microbiology and EM as necessary.Monitor/Audit of aseptic techniques within the aseptic manufacturing environment.Train the manufacturing personnel in environmental monitoring sampling and other aseptic processing techniques (as required).Monitor, track/trend all KPI and periodically provide an EM summary report to Sr. management including participation in Management Review meetings.Prepare and review documents related to microbiology and EM in support of regulatory filings (IND, IMPD, BLA, NDA)Promptly escalating compliance issues to QA management.Conduct internal and supplier audits as required.Coach Intarcia personnel on Quality Systems and regulatory compliance requirements and Identify and implement continuous improvements to QA operations to improve compliance and efficiency of operationsRepresent QA/QC operations during regulatory inspections (PAI, General) including ISO notified body inspection, internal and partner audits.Manage other QA/QC responsibilities as assigned by the supervisor.Qualifications/Experience:Bachelor of Science degree in Biology, Microbiology or Industrial Microbiology is required.A minimum of 12 years of experience in the aseptic, bio-pharmaceutical, or combination products industry managing microbiology laboratory and Environmental Monitoring program.Experience managing contract staff and external contracted testing facilitiesExperience authoring and implementing EM procedures, reviewing protocols and reports.Strong working knowledge of cGMP, QSR, ICH guidance, and ISO 13485.Proactive in identifying opportunities for improvement along with strong problem-solving skillsLeads by example and highly collaborative with a proven ability to work in the cross-functional team environment.Strong verbal, written communication skills are required.Strong computer skills required including Microsoft Excel, Word, and PowerPoint.Able to travel (10-20%)About Intarcia:Intarcia Therapeutics, Inc. is a biotechnology company dedicated to redesigning the prevention, treatment and experience of chronic diseases including diabetes, obesity and HIV. As an organization, we are driven by a desire to create meaningful change in both business and health, rethinking how prescription medicine is delivered. Our dedicated team operates with a "No Analog" mindset-continually pushing boundaries, navigating new terrain and unleashing fresh thinking. It's all part of Intarcia's commitment to enable better outcomes and create impact.The Intarcia Medici Drug Delivery System was developed over a 20-year span in collaboration with a diverse, forward-thinking team of scientists and entrepreneurs with a goal of bridging technology and medicine to transform therapeutic categories. Based on human behavior, the Medici System is intended to relieve the burden and adherence concerns of chronic therapy by delivering prescribed medicines for six months at a time - or potentially longer. Intarcia is also investigating multiple new therapies, including combination therapies for chronic diseases leveraging the convergence of novel medicines from Intarcia's pipeline with the proprietary Medici System.For more information visit www.intarcia.com.No relocation / Local candidates only

Keywords: Intarcia Therapeutics, Inc., San Francisco , Director, Microbiology and Environmental Monitoring - Hayward, Executive , Hayward, California

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