Manufacturing Associate II-IV, All-Stream
Company: IDT Biologika
Location: Rockville
Posted on: February 22, 2021
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Job Description:
POSITION SUMMARY: This position executes the operation of all
cGMP manufacturing (USP, DSP, and Fill) operations.
Responsibilities include conducting cGMP fermentation and/or cell
culture operations, applying scientific and mathematic principals
to the design and execution of downstream purification processes,
and performing all aspects of liquid filling operations including
formulation, media simulations, steam sterilization, CIP, batch
record execution, and following complex SOPs. ESSENTIAL DUTIES AND
RESPONSIBILITIES: * Performs all aspects of fermentation including
Media Prep, Inoculum Prep, Culturing and Harvest activities, Buffer
Prep, CIP, SIP, TFF, and Sterile filtration. * Installs and
operates process equipment including fermenters, centrifuges and
clean-in-place skids; operates and oversees operation of mechanical
equipment including --KTApilot and --KTAprocess, tangential flow
filtration (TFF) systems and buffer preparation systems, liquid
filling machines, Clean in Place (CIP) systems, lyophilizers,
autoclaves, etc. * Troubleshoots, maintains and cleans bioprocess
equipment and facilities. * Participates in all aspects of DSP
operations including buffer preparation, column packing, and filter
sanitization. * Generates batch records and SOPs. * Collects
manufacturing data. Contributes to continuous improvement and
implementation of best practices. * Performs in-process assays to
monitor process performance. * Specifies requisitions and maintains
laboratory materials required for manufacturing activities. *
Completes proper documentation of all work in laboratory notebooks,
draft batch records, QA issued batch records and forms. *
Contributes to the validation of all aspects of fermentation. *
Assists in scale up and execution of non-GMP manufacturing
procedures. * Assists in the resolution of Deviations, CAPAs,
ICARs, and lead other continuous improvement initiatives specific
to cGMP manufacturing. * Works in cleanroom and BSL-II facilities.
* Participates in QA training programs as required. * Maintains
gowning qualification as required. * Performs other duties as
assigned. QUALIFICATIONS AND REQUIREMENTS: * Bachelor's Degree in
Biological Sciences, Engineering or Chemistry required. Master's
degree preferred. * 2 or more years of cGMP manufacturing
experience. * Experience on at least three (3) relevant operational
units (e.g., filtration, cell culture, chromatography, buffer/media
production, fill finish, etc.). * Experience writing and executing
cGMP documentation including SOPs and Batch Records. * Must have
excellent oral and written communications skills, and analytical
and organizational skills. * Experience validating and
manufacturing licensed human vaccines a plus. * Willing to work
evenings and weekends to accommodate production schedules. * Good
penmanship required as per GMP guidelines. IDT offers a competitive
compensation package to include major medical/dental/vision, group
life insurance, STD/LTD plans, 401k plan with company match, and
paid vacation, sick and holidays. IDT Biologika Corporation is an
Equal Opportunity Employer: All qualified applicants will receive
consideration for employment without regard to race, color,
religion, sex, sexual orientation, gender identity, national
origin, or protected veteran status and will not be discriminated
against on the basis of disability.
Keywords: IDT Biologika, Rockville , Manufacturing Associate II-IV, All-Stream, Other , Rockville, Maryland
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