Senior/Lead Manufacturing Associate - Downstream

Baltimore, Maryland
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Type: Direct-Hire

Category: Scientific & Clinical

Job ID: 152914

Date Posted: 12/17/2020


Job Title: :Lead/Senior r Manufacturing Associate - Downstream
Location: Baltimore, MD
Schedule: Flexible,  4 or 5, 8-10 hour shifts/week
Type: Full time, direct hire with competitive compensation +bonus


Responsibilities:

  • Operates pharmaceutical manufacturing equipment such as: depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment
  • Demonstrates, understands and adheres to policies, GMP standards and safety procedures
  • Informs Supervisor on progress of projects, transfer of data, process details, etc.
  • Executes batch records according to GMP and site quality standards
  • Generates Batch Records, SOPs and Protocols as required
  • Responds to off-hour alarms as assigned by the Manager Manufacturing
  • Executes manufacturing cleanroom changeover and activation
  • Supports Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment
  • Supports QA during audits and regulatory inspections
  • Supports other manufacturing process teams and other groups as necessary to achieve Manufacturing team goals

 

Requirements:

  • High School diploma required, BS preferred
  • Minimum 2 years of GMP aseptic bio-pharmaceutical experience (Prior experience in downstream biologics GMP manufacturing, operation of GMP process equipment and aseptic technique are prerequisites.)
  • GMP Protein purification and column chromatography experience (AKTA experience preferred)
  • Hands-on experience with the installation, operation, cleaning and maintenance of biological GMP equipment
  • Computer literate (Word, Excel and PowerPoint


Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.


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