Manufacturing Technician

Planet Pharma; Philadelphia (Philadelphia County); On-site; USD 47,000 - 60,000; Full time

Job summary

Join a forward-thinking company as a Manufacturing Technician, pivotal to the autologous cell therapy program. This role demands expertise in cell culture and aseptic techniques, ensuring compliance with GMP standards. You'll engage in a dynamic environment, performing essential tasks like cleaning, preparation, and operational support. The ideal candidate thrives in a team setting, possesses a keen attention to detail, and is ready to tackle challenges in a fast-paced manufacturing lab. Embrace this opportunity to contribute to groundbreaking biopharmaceutical advancements while enjoying a supportive workplace culture.

Benefits

Medical Insurance

401(k)

Vision Insurance

Qualifications

• 1+ years in biopharmaceutical GMP manufacturing operations.
• 2+ years in cell culture and downstream processing.

Responsibilities

• Execute GMP and support cell therapy manufacturing processes.
• Maintain training documentation and comply with quality standards.

Skills

Cell Culture

Aseptic Gowning

GMP Compliance

Quality Standards Knowledge

Problem-Solving

Education

Bachelor's Degree

Post-Secondary Education

Tools

Cleanroom Equipment

Personal Protective Equipment (PPE)

Job description

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Manufacturing Technician needed!

Overview:

The Manufacturing Technician role is crucial for the autologous cell therapy manufacturing program. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes. The Manufacturing Specialist will be responsible for various tasks, such as cleaning, sanitization, preparation, and fulfilling products for commercial and clinical use. To excel in this role, it is strongly desired that the candidate has a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations. This position works across different shifts. Depending on your assigned shift, you may be required to work on weekends and holidays.

Shifts: A or B

Shift A-Rotation

Week 1:

• Sunday to Tuesday: 6:00PM – 6:30AM

Week 2:

• Sunday to Wednesday: 6:00PM – 5:30AM

OR

Shift B-Rotation

Week 1:

• Wednesday to Saturday: 6:00PM – 5:30AM

Week 2:

• Thursday to Saturday: 6:00PM – 6:30AM

Essential Functions and Responsibilities:

• Develop a comprehensive understanding of and execute GMP proficiently.
• 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.
• Support documentation needs, which include a review of SOPs, Batch Records, Deviations, CAPAs, etc.
• Supports technical transfer and additional research-level testing activities as needed.
• Perform basic revisions as needed to reflect current procedures accurately.
• May support training sessions as a qualified trainer, ensuring training documentation is maintained.
• Assists with identifying training needs, establishing a feedback loop to ensure continuous improvement.
• May work on moderately complex assignments, requiring judgment 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 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 the ability to recognize deviation from accepted practice is required.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.

Required Education, Skills, and Knowledge:

• Minimum 1+ years of experience in biopharmaceutical-based GMP manufacturing operations.
• Minimum 2 years experience in cell culture and associated downstream processing.
• Bachelor's degree or some post-secondary education
• Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
• Ability to mentor and provide best practices to new techniques.

Preferred Education, Skills, and Knowledge:

• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA
• Proactive, results-oriented, self-starter with experience in a complex manufacturing

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

For the Visual Inspection Program, the technician must be able to pass a Vision Exam that includes the following:

• Must not be color
• Must have 20/20 near vision in both eyes (can be corrected)
• Clarity of vision at near and mid-range, depth perception, and ability to identify and distinguish colors may be given a visual exam for visual acuity and color perception.

Physical Demands and Activities Required:

• Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
• Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.
• Must meet requirements for and be able to wear a half-face respirator
• Able to work in a cleanroom with biohazards, human blood components, and chemicals.
• Able to crouch, bend, twist, reach, and perform activities with repetitive motion
• Must be able to lift and carry objects weighing up to 45 pounds

Mental:

Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.

This position will work in both an office and a manufacturing lab setting. When in the lab, must be able to work in a Lab setting with various chemical/biochemical exposures, including latex and bleach, and potential exposure to noise and equipment hazards and strong odors.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Manufacturing

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

401(k)

Vision insurance

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