Job Overview
Ascend Advanced Therapies is seeking a Manufacturing Specialist III to plan and execute manufacturing operations for upstream and downstream unit operations. These operations may include cell culture expansion in both adherent and suspension platforms, process scale-up (bioreactors), and hands on work with column chromatography and filtration techniques.
Key Responsibilities:
· Plan and execute manufacturing operations for upstream and downstream unit operations. These operations may include cell culture expansion in both adherent and suspension platforms, process scale-up (bioreactors), and hands on work with column chromatography and filtration techniques.
· Perform upstream/downstream unit operations in support of GMP manufacturing campaigns.
· Support filling operations as needed
· Collect, record, analyze and summarize data in the course of biologics production and processing.
· Trend in-process manufacturing data to monitor process control and support campaign summary reports.
· Familiarity with modern protein, viral or vaccine production/purification methods.
· Support process development and in-house manufacturing activities for generation of viral vectors for non-GLP and GLP study protocols.
· Assist in maintaining laboratory/manufacturing supplies and equipment.
· Author and revise relevant documentation such as standard operation procedures (SOP's), work instructions (WIS), specifications (SPC), protocols (PRO), reports (RPT), forms (FRM) including production/batch records in support of bioprocessing unit operations associated with biomanufacturing campaigns and process development activities.
· Maintain documents in accordance with GDP and other relevant Quality standards.
· Documents manufacturing process deviations, conduct impact analyses, risk assessments and root cause analyses and drafts corrective and preventive action plans.
· Advanced proficiency in basic biological techniques, methods and guidelines relevant to a biological lab.
· Working knowledge of manufacturing industry standards in Quality cGMP.
· Other duties as assigned
Educational Qualifications
· Preferred: Bachelor’s degree in a scientific discipline.
· Required: High school diploma or GED
Additional Qualifications
· MFG Specialist III: five plus (5+) years of relevant experience or a master’s with three plus (3+) years of relevant experience.
· working knowledge of aseptic technique, cell culture and bioreactors theoretical principles preferred.
· experience with quality management systems and enterprise resource planners
· Fill/finish experience a plus · vaccine or viral vector experience a plus
· understanding/working knowledge of Microsoft word, excel and PowerPoint
· excellent communication skills, both written and verbal
Physical Requirements
medium work (< 50 lbs.) heavy work (< 100 lbs.)
repetitive motion balancing stooping lifting
climbing kneeling/crouching crawling reaching
standing typing/grasping walking pushing/pulling
hearing
· Visual acuity (preparing/analyzing data, transcribing, reading, use of measuring devices, machinery labels, color differentiation, etc.)
· Working conditions (indoor/outdoor, noise levels, hazards, working quarters)
Travel Requirements (%)
This position does not have Travel Requirements
Supervisor Responsibilities
· This position does not require previous supervisory experience.
Benefits: