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.

• 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 and manufacturing supplies and equipment.
• Author and revise relevant documentation such as standard operating procedures (SOPs), work instructions (WIS), specifications (SPC), protocols (PRO), reports (RPT), forms (FRM) including production and 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.
• Document manufacturing process deviations, conduct impact analyses, risk assessments and root cause analyses, and draft corrective and preventive action plans.
• Advanced proficiency in basic biological techniques, methods and guidelines relevant to a biological laboratory.
• Working knowledge of manufacturing industry standards in Quality cGMP.
• Other duties as assigned.

• Preferred:
  Bachelor’s degree in a scientific discipline.
• Required:
  
  High school diploma or GED.

• 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 bioreactor 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.

• 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).

This position does not have travel requirements.

• 401(k)
• 401(k) matching
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Vision insurance