Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations is strongly desired.
Shifts: A or B
Shift A-Rotation
• Week 1
o Sunday to Tuesday: 6:00PM – 6:30AM
• Week 2
o Sunday to Wednesday: 6:00PM – 5:30AM
OR
Shift B-Rotation
• Week 1
o Wednesday to Saturday: 6:00PM – 5:30AM
• Week 2
o Thursday to Saturday: 6:00PM – 6:30AM
Essential Functions and Responsibilities
• Develop a Subject Matter Expert (SME)-level understanding of and be able to skillfully execute as well as troubleshoot GMP cell therapy manufacturing process(es).
• Complete training sessions and ensure training documentation is maintained.
• Understand and comply with quality standards and requirements as documented.
• Provide operational support functions including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
• Perform document review, including executed Batch Records and Logbooks.
• Aseptic Manufacturing Technicians are required to work their assigned schedule. The first few months of onboarding training for this position will occur during regular work week hours (1st shift M-F); however, once the technician is trained, they will be assigned to a shift that may include weekends, evenings, and holidays, as needed (i.e. Shifts may be Sunday to Wednesday, Wednesday to Saturday, Thursday to Sunday, etc). May be required to work overtime.
• Support documentation needs, which may include drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
• Execute documentation Change Controls of SOPs, Batch records, etc. as needed.
• Support interdepartmental projects in a contributor capacity.
• Supports technical transfer and additional research level testing activities, as needed.
• Perform basic revisions as needed to accurately reflect current procedures.
• Support departmental projects in a contributor capacity.
• May support training sessions as a qualified trainer, ensuring training documentation is maintained.
• Assists with identification of training needs, establishing a feedback loop to ensure continuous improvement
• May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts.
• Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
• Attend or hold the daily huddle meeting and escalates issues/concerns at that forum to Area Management for further investigation.
• Ability to work in a team environment and independently as required. Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Other duties as assigned.
Basic Qualifications
• Bachelor's degree or some post-secondary education or equivalent experience.
• Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
• Ability to mentor and provide best practices to new technicians.
• Must be able deal with ambiguity – ready to change gears and plans quickly, able to manage constant change.
• Must be able to read, write and understand English especially for Good Documentation Practices, and be proficient in Microsoft (Excel, Word, Outlook).
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• Ability to build relationships quickly and credibly.
• Ability to work successfully in a fast-paced team-oriented environment.
• Must adhere to core values, policies, procedures and business ethics.
Preferred Qualifications
• Minimum 2+ years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
• Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors. May be given a visual exam for visual acuity and color perception.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Proactive, results oriented, self-starter with experience in a complex manufacturing environment.
• May require up to 5% travel, based on business need.
Sr. Aseptic Manufacturing Technician (Night Shift)
300 Rouse Boulevard Philadelphia, PA 19112 US
Posted: 01/22/2025
2025-01-22
2025-02-22
Employment Type:
Direct Hire/Perm
Job Category: Scientific
Job Number: 616271
Is job remote?: No
Country: United States
Job Description
As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations is strongly desired.
Shifts: A or B
Shift A-Rotation
• Week 1
o Sunday to Tuesday: 6:00PM – 6:30AM
• Week 2
o Sunday to Wednesday: 6:00PM – 5:30AM
OR
Shift B-Rotation
• Week 1
o Wednesday to Saturday: 6:00PM – 5:30AM
• Week 2
o Thursday to Saturday: 6:00PM – 6:30AM
Essential Functions and Responsibilities
• Develop a Subject Matter Expert (SME)-level understanding of and be able to skillfully execute as well as troubleshoot GMP cell therapy manufacturing process(es).
• Complete training sessions and ensure training documentation is maintained.
• Understand and comply with quality standards and requirements as documented.
• Provide operational support functions including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
• Perform document review, including executed Batch Records and Logbooks.
• Aseptic Manufacturing Technicians are required to work their assigned schedule. The first few months of onboarding training for this position will occur during regular work week hours (1st shift M-F); however, once the technician is trained, they will be assigned to a shift that may include weekends, evenings, and holidays, as needed (i.e. Shifts may be Sunday to Wednesday, Wednesday to Saturday, Thursday to Sunday, etc). May be required to work overtime.
• Support documentation needs, which may include drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
• Execute documentation Change Controls of SOPs, Batch records, etc. as needed.
• Support interdepartmental projects in a contributor capacity.
• Supports technical transfer and additional research level testing activities, as needed.
• Perform basic revisions as needed to accurately reflect current procedures.
• Support departmental projects in a contributor capacity.
• May support training sessions as a qualified trainer, ensuring training documentation is maintained.
• Assists with identification of training needs, establishing a feedback loop to ensure continuous improvement
• May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts.
• Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
• Attend or hold the daily huddle meeting and escalates issues/concerns at that forum to Area Management for further investigation.
• Ability to work in a team environment and independently as required. Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Other duties as assigned.
Basic Qualifications
• Bachelor's degree or some post-secondary education or equivalent experience.
• Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
• Ability to mentor and provide best practices to new technicians.
• Must be able deal with ambiguity – ready to change gears and plans quickly, able to manage constant change.
• Must be able to read, write and understand English especially for Good Documentation Practices, and be proficient in Microsoft (Excel, Word, Outlook).
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• Ability to build relationships quickly and credibly.
• Ability to work successfully in a fast-paced team-oriented environment.
• Must adhere to core values, policies, procedures and business ethics.
Preferred Qualifications
• Minimum 2+ years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
• Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors. May be given a visual exam for visual acuity and color perception.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Proactive, results oriented, self-starter with experience in a complex manufacturing environment.
• May require up to 5% travel, based on business need.
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