Manufacturing Specialist III

Manufacturing Specialist III Ascend Advanced Therapies FL, Inc. Alachua, FL Job Details Full-time 2 days ago Benefits Health savings account Health insurance Dental insurance 401(k) Flexible spending account Paid time off Parental leave Employee assistance program Vision insurance 401(k) matching Life insurance Retirement plan Qualifications Regulatory compliance Corrective and preventive actions (CAPA) GMP High school diploma or GED Quality assurance Bachelor's degree Batch records Quality audits Root cause analysis FDA regulations Pharmaceutical manufacturing facility experience Full Job Description 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:

401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Health savings account Life insurance Paid time off Parental leave Retirement plan Vision insurance Application Question(s): Will you now or in the future require employer sponsorship for employment visa status? Do you have at least 5 years of experience in a GMP-regulated biologics, cell therapy, gene therapy, or pharmaceutical environment? Do you have experience reviewing or approving GMP quality documentation such as batch records, deviations, CAPAs, change controls, specifications, or product release documentation? Do you have experience hosting or supporting FDA, client, or regulatory inspections? Do you have experience working in a gene therapy, cell therapy, biologics, vaccine, or CDMO environment?

Education:

Bachelor's (Preferred)

Experience:

GMP biologics, cell therapy, or gene therapy quality: 5 years (Required)

Work Location:

In person