Aseptic Manufacturing Technician II/Sr./Lead

MUST HAVES:

• Minimum B.S. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience
• 1-5 years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream processing

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 B.S. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
• 0-5 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.