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.