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Associate Director of Manufacturing

Company: Kelly Services
Location: Tallahassee
Posted on: October 17, 2019

Job Description:

Kelly Services is currently seeking (2) DIRECT HIRE Associate Directors. (1) Associate Director of Upstream Manufacturing and (1) Associate Director of Downstream Manufacturing for an esteemed client located in Northern, FL. We are seeking candidates who specialize in viral vector and cell gene therapies. Ideal candidates will have extensive experience in a GMP manufacturing setting specialized in downstream manufacturing of biologics. Direct Hire + Benefits + Relocation Assistance Work Hours: Monday through Friday, 8:00 AM to 5:00 PM on a FLEX schedule.  Overtime, weekend and holidays required to meet project timelines as necessary. Downstream: Must have recent knowledge of purification and viral vectors and antibodies. This role holds direct reports. Upstream: Must have a strong technical understanding of cell culture processes, multiple platforms and multiple cell types. The Upstream Associate Director will manage up to 16 people (supervisors and techs). Position Description/Summary: Responsible for leading GMP manufacturing operations. Serve as a subject matter expert and provide strong technical and organization leadership for the GMP manufacturing organization effectively supporting multiple viral vector purification operations. Manage manufacturing operations including but not limited to planning, GMP preparation, act as receiving and sending unit for technology transfer, and day-to-day operational decision making. Work closely with a cross functional team of Process Development, Tech Transfer, Quality Assurance, Facilities, Engineering, and Project Management to ensure production operations are safe and right-first-time. Adhere to all Safety and Quality standards of the organization and contribute to continuous improvement in the areas of Safety, Quality, Delivery, Cost, and People Essential Responsibilities: Manage a production and scientific team performing cGMP manufacturing activities according to standard operating procedures (SOPs) and batch records in accordance with assigned daily tasks and production schedule Provide on the floor oversight as needed leading right-first-time production operations Act as a subject-matter-expert on cGMP and viral vector purification techniques (e.g. chromatography, centrifugation, tangential flow filtration, etc.) Ensure meticulously maintain facility records, batch records, and process/system records as required throughout the manufacturing process according to GDP standards Through strict adherence to manufacturing controls, ensure finished drug substance/drug product and all intermediates comply with applicable regulatory requirements (e.g. FDA, EMA), cGMPs, QA/QC and safety standards Adheres to the production schedule ensuring on-time delivery and efficient production logistics Ability to utilize Quality Systems (Deviations, CAPAs, Change Control, etc.) Other duties as assigned Position Requirements: degree with 8+years of experience, ’s degree with 5+ years of experience, or PhD with 4+ years of experience or advanced degree in biochemical engineering, chemical engineering, biochemistry or a related discipline. Strong interpersonal and communications skills; written and oral.  Solid understanding of applicable regulatory requirements.

Keywords: Kelly Services, Dothan , Associate Director of Manufacturing, Other , Tallahassee, Alabama

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