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23 days old

Upstream Manufacturing Manager

Kelly Services
Rockville, MD 20851
Kelly Scientific has an exciting dire hire position as an **Upstream Manufacturing Manager** with a biomanufacturing and immunobiology company in **Rockville, MD** . The candidate in this position is to take the lead in the upstream process of proteins, viral vectors and vaccines for phase 1 and 11 clinical trial material. This will encompass service in all upstream activities within the Manufacturing department and additionally encompass assistance to the Process Development departments, as necessary.





**Responsibilities:**




+ Knowledge and experience with Stir Tank Bioreactor system and MFCS software used for upstream tasks.

+ Hands on experience with Aseptic Technique and Cell Culture process for Adherent and Suspension Cell lines

+ Maintain and foster an environment of safety in the laboratory by becoming trained in and adhering to the safety policies of the laboratory.

+ Comply with GMP regulations by strict adherence to departmental policies and procedures and timely accurate completion of records as needed.

+ Lead a team of supervisors and direct reports by providing guidance and supervision.

+ Foster team building and provide the necessary training to other staff members as required

+ Generate the applicable GMP documents for review and approval and validation.

+ Ensure smooth transition of projects from Process Development to Manufacturing

+ Ensure that all processing equipment and instruments are identified and maintained as per internal approved procedures.

+ Communicate and suggest regular process improvement to management

+ Work effectively with QA/QC, manufacturing, facilities and other support staff personnel.

+ Cross train as needed on new processes.





**Qualifications:**




+ Masters Degree in Biotechnology or related field

+ Experience with T flasks, Shaker flasks, Cell Factories, HYPERstacks, and Stirred Tank Bioreactors a plus

+ Must be proficient in cell culture techniques, systems and preparation of buffers and solutions and Bioreactor operations.

+ Must have strong experience in the transfer and production of GMP candidates

+ Experience in a GMP environment required.

+ Proven supervisory and leadership experience.

+ Demonstrated ability to evaluate new technologies, new applications of existing technologies and apply information and data from multiple scientific fields of study to create new solutions.

+ Effective written and oral communications skills (within all levels of the organization and with external colleagues and collaborators), interpersonal skills, analytical/problem solving skills, cross-functional team leadership skills, goal setting/time management skills are required.

+ Ability to perform statistical analyses and presentation of data.






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



Kelly Science 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/nontraditional 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2020-05-08 Expires: 2020-06-08

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Upstream Manufacturing Manager

Kelly Services
Rockville, MD 20851

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