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1+ months

Biopharmaceutical Manufacturing Associate

Kelly Services
The Woodlands, TX 77381
**_Biopharmaceutical Manufacturing Associate, Houston, TX area (Direct Hire)_**



Kelly Services is currently seeking a Biopharmaceutical Manufacturing Associate for our biopharma customer in the Houston, TX area.



**Job Responsibilities**



As a Biopharmaceutical Manufacturing Associate you will actively address complex cGMP manufacturing issues. The individual is responsible for analyzing process technologies in support of new project proposals and takes responsibility for the technical transfer into the manufacturing group. This individual must work in a collaborative manner coordinating the transfer of biological drug processes from process development (internal or client) groups in a CMO environment.



**_Essential Functions:_**




+ Applies scientific and cGMP manufacturing expertise to research and resolve issues in the technology transfer and implementation of client specified manufacturing processes for biologics including viral based products and vaccines.

+ Leads multiple overlapping cross-functional technology transfer teams that include client technical staff and internal process development and manufacturing teams. Will also be responsible for assisting other teams as SME.

+ Research and recommend single-use process equipment of appropriate scale and quality for the cGMP execution of client specified manufacturing processes.

+ Responsible for the preparation of user requirements, vendor quotes, and purchasing of equipment as well as supporting capital projects by providing technical expertise.

+ Oversees and leads small complex engineering projects.

+ Assist in overseeing contractor activities, as required.

+ Provides technical information for the preparation of change controls, protocols, and new user training for the process equipment.

+ Reviews process requirements for GMP manufacturing through process specifications and batch records.

+ Identifies raw materials and consumables of appropriate quality for the cGMP execution of client specified manufacturing processes; assists in the preparation of material specifications, vendor quotes, and the purchase of the materials.

+ Responds to client and/or internal staff questions or concerns about cGMP equipment, materials, and procedures.

+ Uses key and critical process parameters and their associated critical quality attributes to assist in the preparation of product specifications.

+ Provides data analysis from each manufacturing run that will be included in intermediate and final project summary reports and other team deliverables.

+ Contributes to and ensures the achievement of goals and tech transfer milestones on multiple projects without delay in schedule or excessive use of resources.

+ Perform all other duties as assigned.



**_Qualifications:_**




+ PhD, Master or Bachelors degree in Engineering, Chemistry, Biology, Life Sciences or a related field with 5-10 years of relevant experience

+ Experience in the manufacturing environment for biologics and vaccine manufacturing.

+ Hands on laboratory or manufacturing experience with biologics projects.

+ Knowledge of single-use manufacturing equipment and materials.

+ Understanding and experience in aseptic techniques.

+ Document writing including protocols, batch records, and SOPs and summary reports.

+ Work Experience in a GMP environment.



This is a **direct hire** opportunity with a salary dependent upon education and relevant experience. Work schedule is Monday through Friday, days. If you meet the above qualifications, please submit your resume 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: 2020-08-24 Expires: 2020-10-22

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Biopharmaceutical Manufacturing Associate

Kelly Services
The Woodlands, TX 77381

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