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 ÄKTApilot and ÄKTAprocess, 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.
|
