Aseptic Manufacturing Technician II

Planet Pharma; Philadelphia (Philadelphia County); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading company in immune-oncology is seeking an Aseptic Manufacturing Technician to join their Operations team. The role involves executing cell therapy manufacturing processes while adhering to GMP standards. Candidates should have experience in biopharmaceutical manufacturing and a strong quality mindset. This position offers the opportunity to contribute to innovative cancer therapies and work in a fast-paced team environment.

Benefits

Medical insurance

Vision insurance

Qualifications

• 2+ years of biopharmaceutical GMP industry experience.
• Experience in cell culture and downstream processing.

Responsibilities

• Execute cell therapy manufacturing process.
• Ensure compliance with GMP and SOPs.
• Support documentation and training.

Skills

Cell Culture

Aseptic Processing

Quality Mindset

Education

A.S. degree in biology

B.S. degree

Tools

Microsoft Excel

Microsoft Word

Microsoft Outlook

Job description

1 week ago Be among the first 25 applicants

• Minimum A.S. degree in biology, biochemistry, bioengineering, or related technical field with 2+ years of biopharmaceutical GMP industry experience OR B.S. degree with 1+ years GMP industry experience
• Experience with cell culture and associate downstream processing

Schedule:

• Week 1: Sunday-Tuesday, 7:30am-8:00pm

Job Overview:

We are seeking an Aseptic Manufacturing Technician to join the Operations team for our new manufacturing site. We are an immune-oncology company focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL). The companies lead candidate is an autologous, ready-to-infuse cell therapy, that has demonstrated distinctive efficacy in the treatment of metastatic melanoma. The company has Phase 2 clinical trials in progress for squamous cell carcinoma of the head and neck, cervical carcinoma, non-small cell lung cancer, and immunotherapy for solid tumors. The company currently is developing its commercial manufacturing capacity to support development and launch of these assets.

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 required.

Specific Responsibilities

• Develop a comprehensive understanding of and be able to proficiently execute Iovance’s current cell therapy manufacturing process.
• Complete training sessions and ensure training documentation is maintained.
• Understands and complies with quality standards and requirements as documented.
• Provides operational support functions including materials stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance.
• Supports technical transfer and additional research level testing activities.
• Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
• Support documentation needs, which may including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
• Attends the daily lab 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.

Qualifications

• Minimum A.S. degree in biology, biochemistry, bioengineering, or related technical field with 2+ years of biopharmaceutical GMP industry experience OR B.S. degree with 1+ years GMP industry experience
• Minimum 1+ years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
• Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
• Ability to mentor and provide best practices to other members of the team.
• Ability to build relationships quickly and credibly.
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• Proactive, results oriented, self-starter with experience in a complex manufacturing environment.
• Ability to work successfully in a fast-paced team-oriented environment.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Must adhere to companys core values, policies, procedures and business ethics.
• Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).
• May require up to 5% travel, based on business need.

Physical Requirements

• Must be able to work in environment with variable noise levels
• Must be able to work in Lab setting with Biohazards /various Chemicals
• Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors.
• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
• Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards and strong odors.
• Ability to stand/sit/walk for long periods of time
• Ability to crouch, bend, twist, reach, and perform activities with repetitive motions
• Ability to lift 20 lbs.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Science, and Manufacturing

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

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