Upstream Manufacturing Associate ll/lll

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.

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 (SOPs, BRs), 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

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)

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

Aerotek is acting as an Employment Agency in relation to this vacancy.