Aseptic Manufacturing Technician

Proclinical is seeking an Aseptic Manufacturing Technician for a leading biotechnology company located in Philadelphia, PA. 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.

Job Responsibilities:

• Develop a comprehensive understanding of and be able to proficiently execute the company'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.

Skills and Requirements:

• 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.
• 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.
• 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

If you are having difficulty in applying or if you have any questions, please contact Sam Jankura at (+1) (617) 671-0335 or S.Jankura@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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