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20 days old

Associate Director of Manufacturing Science & Technology - BioPharma

Kelly Services
Durham, NC 27722
Kelly Scientific is seeking a **Senior Manager or Associate Director of Manufacturing Science & Technology** for a **DIRECT HIRE** opportunity in **Durham, NC** who will be responsible for establishing and directing the execution, resources, business processes and tech transfer for both the upstream or downstream tech transfer groups, process validation and pilot lab operations at a Commercial Manufacturing site.



The MS&T Sr. Manager / Associate Director will manage a team of Engineers and Scientists that lead tech transfer projects and will introduce new commercial programs to ensure projects are executed efficiently and in a timely manner.



**The ideal candidate will have:**




+ **Experience leading or starting up a new facility**

+ **Experience with Life Cycle Management**

+ **Experience with or an understanding of Mammalian Cell Culture and Purification processes**

+ **Commercial/Clinical Manufacturing Experience is highly preferred**

+ **Experience within a CDMO environment or similar**

+ **Ability to collaborate with other teams to successfully fulfil company objectives**



The MS&T Sr. Manager / Associate Director should demonstrate proven technical expertise in upstream or downstream biologics and demonstrate of industry leading best practices and guidance around process validation and the pilot lab. The scope of this role includes:




+ Oversee new commercial product introduction from Stage 2 PPQ through Stage 3 CPV Process Validation and Pre-Approval Inspection (PAI)

+ Establish and maintain the procedures, business processes and tools/systems for tech transfer, process validation and laboratory activities

+ Establish plans and strategies to ensure successful cGMP production by actively collaborating with manufacturing operations, quality and supply chain

+ Manage scheduling and resources and lead staff meetings.

+ Recruit and retain talent within organization. Develop plans for contractor support of short-term projects

+ Represent the department during audits, client meetings and multi-disciplinary meetings with boards of health and upper management.

+ Lead multi-disciplinary projects to improve manufacturing operations, adopt new technologies, increase production revenues, reduce cost of goods, streamline practices.

+ Perform a wide range of managerial duties pertaining to employees including hiring, on-the-job training, career development, appraising performance, promotion and disciplinary effort. Identify opportunities and provide the means for employees to pursue career growth.



**Job Responsibilities:**




+ Establishes and maintains the procedures, business processes and tools for tech transfer, process validation and pilot lab operations

+ Leads multi-disciplinary cross-functional projects

+ Manages and facilitates resources to ensure execution success

+ Represents department in various technical and projects team meetings with client , board of health and upper management

+ Provides technical guidance to tech transfer, process validation and laboratory activities as required based on industry best practices



**Minimum Requirements:**




+ BS in Science or Engineering with minimum of 13 years industry experience, Masters with 11 years industry experience or PhD with 9 years industry experience.

+ Industry leader in biologics tech transfer, processing and operations

+ Expertise in cGMP production operations is required

+ Industry leading technical transfer and scale up is required

+ Experience with process validation and GMP compliance requirements is required

+ Experience working in a cGMP manufacturing environment is a plus



**Apply Today for Immediate Consideration!**




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



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-11-13 Expires: 2020-12-19

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Associate Director of Manufacturing Science & Technology - BioPharma

Kelly Services
Durham, NC 27722

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