Latitude, Inc. Downstream Manufacturing Associate in Bethesda, Maryland
The Downstream Manufacturing Associate is responsible for assisting with organizing, running, and sustaining the manufacturing operations process at the plant/site. This individual will work on the manufacturing floor to produce product, media/buffer preparation, learn to troubleshoot equipment, participate in interviews on deviations, stocking of items in supply/ production / warehouse area, standardizing equipment and cleaning production area.
Assist in manufacturing led investigations through partnerships with Quality and other business units at the site.
Assist BPEs to determine root cause, implement a solution and a verification check to ensure the fix was effective.
Assist with creation and on-going maintenance of all pertinent equipment, policies, and procedures.
Be flexible in rotations between upstream and downstream to learn aseptic techniques, cell culture, recovery, purification, aseptic fill/finish.
Assist in producing clinical and commercial material on an annual basis that meets the site?s strategic objectives and is compliant with cGMPs.
Support the product requirements to ensure that all products are produced according to plan. Learn cGMP and cGDP and ensure cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed.
Responsible for maintaining quality standards to meet cGMP requirements, CFR?s, and internal company policies directly related to the manufacturing process.
Partner with Quality to ensure a quality and compliant manufacturing environment.
Assist the technical operations team to resolve any issues related to production.
1+ years? experience in GMP environment with Bachelors of Science Degree in Biology, Chemistry, Biotechnology or applicable field or equivalent experience.
Excellent oral and written communication skills.
Experienced in downstream manufacturing processes.