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Manufacturing Associate

Harmans, MD 21077

Posted: 12/23/2024 Employment Type: Contract Job Category: Scientific Job Number: 616612 Is job remote?: No Country: United States

Job Description


The Manufacturing Associate II is responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing. Lifting to 40 lbs., unassisted may be required at times. Frequent standing and walking is required, as this role requires presence on the manufacturing floor. Shift work and weekend work is required.

KEY RESPONSIBILITIES:
  • Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps
  • Generates operational protocol(s), internal or external documents including SOPs, BPRs, deviations and summary reports
  • May work with Process Development team and collaborate with Manufacturing Sciences and Technology group to transfer new projects into GMP
  • Generate and revise internal and external documents (SOPs, BRs)
  • Support initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs.
  • Troubleshoot process and equipment problems; Work with Facilities and Validation to maintain manufacturing equipment
  • Recommend equipment and other supply purchases within the production areas
  • Develop creative solutions to operational problems by leveraging knowledge of available theories and proven solutions.
  • Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays
  • Work closely with various departments and aid other teams as necessary
  • Interact with clients during initial and subsequent manufacturing campaigns; may be responsible to oversee and escort the person-in-plant (PIP) during manufacturing campaigns
  • Participate in facility expansion and equipment validation activities

Education & Experience:
  • HS or GED with 4-7 years’ experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance

OR
  • Associate’s degree in a Scientific, Engineering or Biotech field with 2-4 years’ experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance

OR
  • Bachelor’s degree in a Scientific, Engineering or Biotech field with 1-3 years’ experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance
  • Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
  • Excellent documentation skills including comprehension, review & establishing Batch Production Records, SOP’s, deviation & summary reports
  • Thorough knowledge of current Good Manufacturing Practices (cGMP’s), and all relevant safety procedures within the company. General understanding of most areas in Manufacturing and supporting functional groups.
  • Must be team-oriented (proactively builds healthy working relationships between peers, their department and other groups).
  • Able to fluently communicate in English. Exhibits excellent written and oral communication skills.
  • Possesses a basic knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.






Pay Rate Range: $20-34/hr depending on experience 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Harmans, MD

Ready to take your career to new heights? Explore job opportunities in the vibrant area surrounding Harmans, Maryland. Nestled in Anne Arundel County, Harmans offers a perfect mix of urban convenience and small-town charm. This thriving region boasts close proximity to Baltimore and Washington D.C., providing ample networking opportunities and career growth potential. Enjoy the beauty of nearby attractions like the National Aquarium in Baltimore, the artistic displays at Maryland Hall for the Creative Arts, and the excitement of the Baltimore Ravens football team. Indulge in delicious Maryland blue crab cuisine and take in the scenic beauty of Greenbury Point Nature Area. Start your next career adventure in Harmans, MD, and discover why this region is a hidden gem for job seekers.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.