Manufacturing Specialist III

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.