9 days old

Associate Director of Downstream - Process Development (Biologics & Virals)

Kelly Services
Durham, NC 27722
**_Referrals Welcome! $500 Referral Bonus! Must be able to relocate to Florida with Assistance. Direct Hire Opportunity w/Bonus._**

Kelly Services is currently hiring an **Associate Director of Downstream Process Development** for a **DIRECT HIRE** position outside of Gainesville, FL. **This is a full-time role with benefits and relocation assistance** .

The Associate Director of Downstream Process Development will ensure we produce the highest quality therapies for clinical and toxicological study use and will direct downstream development functions including process design and transfer, process optimization, process scale up, planning, statistical and data analyses, adherence to PD and cGMP standards, preparation, design of related documents (SOPs, batch records, etc.), supervising, hiring and training unit personnel, and leading hands-on, in critical upstream development activities and effectively communication with clients.

**The ideal candidate MUST HAVE:**

+ Experience working with a CDMO a plus (not required)

+ Work experience in a cGMP environment

+ Knowledge of at-scale downstream processes as well as applicable modern analytics

+ Excellent technical writing and oral communication skills are required

+ Applicants with clean room experience and/or work experience in an FDA regulated cGMP environment (preferred not required)

+ Strong interpersonal and communications skills; written and oral.

+ Solid understanding of applicable regulatory requirements.

**Job Responsibilities:**

+ Will be responsible for preparing robust processes for viral vector production using chromatography, centrifugation and filtration systems and development of new technologies that support this platform.

+ Will work closely with technical transfer, process engineering, manufacturing units, quality assurance, quality control, CAM MS&T, and business development to complete these responsibilities.

+ This includes support for operations and other process support teams providing scientifically and regulatory sound recommendations, improving efficiency, meet timelines and development successful processes while operating in compliance with cGMP regulations, and SOPs

+ Design and transfer, optimize, scale up, plan, statistical and data analyses of robust viral vector purification processes

+ develop and evaluate column chromatography, centrifugal, filtration and other separation-based methods for viral vectors

+ Technical lead for specific client projects

+ Design and executing experiments to expand and optimize vector manufacturing processes.

+ Provide on-the-floor technical support.

+ Provide technical leadership in developing new technologies in viral vector purification.

+ Define relevant operational/technical standards and practices for the site.

+ Identify and drive implementation of improvements to maximize throughput and capacity utilization.

+ Responsible for providing development plans and reports

+ Selecting, developing and leading a highly effective PD team to achieve these goals

+ Will work closely with Process Development, Quality Assurance and Operations to transfer new processes into the GMP environment including, batch record development, material sourcing, buffer planning and identifying and configuring new equipment and process rooms, as needed.

+ Work with project management team to set the production schedule and communicate with existing clients.

**Job Requirements:**

+ Bachelor degree with 8+years of experience, Masters degree with 5+ years of experience, or PhD with 4+ years of experience


+ A Ph.D. degree in biochemical engineering, chemical engineering, molecular biology, virology, biochemistry and ten plus years of appropriate experience.


+ Medical, dental, and vision coverage

+ Company paid Disability and Life Insurance benefits

+ 401(k) Plan with a generous company match

+ All full-time employees are also provided with paid time off, paid company holidays, share appreciation rights, and an incentive bonus plan.

Apply Today for Immediate Consideration!

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll 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 careerconnect 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 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.


Posted: 2018-12-05 Expires: 2019-01-05

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Associate Director of Downstream - Process Development (Biologics & Virals)

Kelly Services
Durham, NC 27722

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast