Fermentation and Purification Manufacturing Specialist (2362327)

Title: Manufacturing Specialist Salary range: $35000-40000, or low 40's depending on education and experience.

Summary:
The Manufacturing Specialist is responsible for performing all phases of operation in mammalian cell culture, microbial fermentation, and/or purification in a biopharma manufacturing facility. This work is performed under GMPs.

Essential Duties and Responsibilities:

' Will operate large scale biopharma manufacturing equipment such as: fermentors, centrifuges, TFF skids, microfluidizers, CIP skids, chromatography skids/columns, formulation equipment, etc.
' Preparation of various types of media, buffers and cleaning reagents.
' Participate in all phases of support work for GMP bulk manufacturing such as: suite changeovers/activations, light maintenance on process equipment, cleaning, supplies ordering, and maintaining suite inventory.
' Participate in ongoing development, writing and revision of SOPs and SMPs.
' Accurate and timely execution of all GMP documentation such as: batch records, SMPs and logbooks.
' Will work with the process development scientists in the tech transfer of projects from that area to manufacturing.
' Provide assistance to validation engineers in the validation of manufacturing equipment and processes.
' Will interact with the clients on the floor in a professional manner.
' Close interaction with Manufacturing Process Engineers for process trouble-shooting and/or optimization is required.
' Will demonstrate an understanding and adherence to policies, GMP standards and safety procedures.
' Provide assistance to Sr. Manufacturing Specialists and/or supervisors in the training of new employees.
' Provide support to QA for audits and regulatory inspections.
' Will be point of contact for the supervisor or manager when the Sr. Manufacturing specialist is not available.




Minimum Qualifications:

' Bachelor degree with a minimum 2 years of industrial experience in large-scale fermentation, cell culture and/or purification, HS diploma with a minimum 4 years experience or an equivalent combination of education and experience.
' Must be able to provide technical support for all phases of cGMP bulk biologics manufacturing.
' Must have a good working knowledge of mammalian cell culture, microbial fermentation and/or purification processes.
' Will be required to work flexible schedules (shiftwork) and holidays as needed.
' Must be computer literate (Word, Excel).
' Must be able to lift a minimum of 50 lbs and to work on ladders.
' Clear verbal and written communication between the immediate supervisor and/or manager and other staff is required.
' Must be able to work effectively as part of a team, in a very dynamic environment.
' Will need to develop and maintain good working relationships with the clients and other departments.

If interested please apply online and call Meredith to introduce yourself at 410-203-9588.Kelly Services is an Equal Opportunity EmployerContact?Information?:.6021 University Blvd.
Ellicott City?MD?21043