Manufacturing Associate III

The Manufacturing Associate 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.

Shift work and/or weekend work is required at times.

Key Responsibilities include but are not limited to:

• 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
• Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines

Downstream:

• Leverages knowledge and application of the theories and principles utilized to solve operational, as well as routine tasks in the purification of proteins, antibodies, etc. for Phase I/II GMP manufacturing
• Works closely with purification management to initiate new manufacturing projects and helps develop processes/techniques to meet contract objectives
• Perform buffer preparations, in-process sampling, formulation of bulk drug substance
• Conducts changeover and activation procedures for clean room suites and equipment
• Submits in-process and cleaning samples to Quality Control with required documentation
• Has excellent understanding and knowledge of isolating and purifying proteins from microbial and cell culture processes
• Extensive experience with chromatography equipment, columns, TFF, CIP procedures and of processes to purify bulk proteins, antibodies, etc. (HIC, IEX, Affinity)

Upstream:

• Leverages knowledge and application of the theories and principals utilized to solve operational, as well as routine tasks in the operation of microbial or cell culture processes (media/buffer prep, cell passaging, bioreactor production, harvesting operations)
• Have excellent understanding and knowledge of mammalian, insect, viral and microbial processes
• Experienced with suspension and adherent cell cultures
• Experienced in using stainless and disposable single-use bioreactors (WAVE, Sartorius, Xcellerex)
• Extensive experience in producing Master and Working banks (mammalian, insect, viral and microbial)

Experience & Education:

• HS or GED with 7-10 years’ experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance

OR

• Associate degree in a Scientific, Engineering or Biotech field with 4-7 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 3-5 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