Kelly Services Downstream Manufacturing Associate Director in Alachua, Florida

Associate Director Downstream Manufacturing Gainesville, FL

Kelly Scientific Resources is seeking an experienced Associate Director of Downstream Manufacturing specializing in viral vector and cell gene therapies. This is a direct hire position. Monday-Friday on the 1st shift.

Ideal candidates will have extensive experience in a GMP manufacturing setting specialized in downstream manufacturing of biologics.

Position Description/Summary:

The Associate Director Downstream GMP is responsible for leading the downstream GMP manufacturing operations. The Associate Director will 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. The individual must 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. The incumbent will 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. The Associate Director will 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

Knowledge, Skill, and Requirements:

Required:

Bachelor degree with 8+years of experience, Master’s degree with 5+ years of experience, or PhD with 4+ years of experience

Bachelor 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.

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.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus. Ability to gown aseptically to enter cleanroom. Ability to stand for long periods and wear a respirator.

Why Kelly ® ?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—

providing you with opportunities to work on today’s most challenging, research-intensive, and relevant

projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help

advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000

scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world

a better place. Let Kelly fuel your career—connect with us today.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect

with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,

Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is

committed to employing a diverse workforce. Equal Employment Opportunity

is The Law.