Biopharmaceutical Manufacturing Associate Job at 24HRPO in Philadelphia

Overview:

Responsible for manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).

Responsibilities:

• Understands aseptic technique concepts
• Has performed aseptic technique, is able to identify unacceptable practices and make spot corrections to performance
• Understands and is able to explain ‘why’ of acceptable and unacceptable aseptic technique practices
• Trains others on basic aseptic operational techniques such as media preparation, thaw, passage and harvesting
• Able to operate and maintain equipment
• Understands the maintenance of equipment
• Understands most operations and functions of equipment and is able to perform major troubleshooting
• Identifies needs for corrective maintenance
• Assists with sourcing and purchasing of standard equipment
• Performs solution and material preparation
• Possesses basic technical knowledge and background in the pharmaceutical and biotechnology industry
• Possesses basic and fundamental engineering and mechanical knowledge and is able to apply in the manufacturing area
• Possesses basic and fundamental facility start-up experience
• Has participated in facility start-ups and may participate on a subteam to support
• Participates on and performs technical transfer activities
• Provides feedback for facility fit
• Helps with application of GMP concepts and is able to recommend and identify improvements as the process develops during phases of technical transfer
• Executes validation activities
• Provides input and reviews validation documentation
• Scheduled, receives and organizes materials
• Performs material procurement activities
• Creates and revises material documents
• Creates CS forms
• Identifies, communicates and resolves material discrepancies
• Uses all support systems (e.g. LIMS) with demonstrated proficiency and able to act as an subject matter expert (SME) on a system
• Understands the concept of and has performed or experience with manufacturing processes and methods
• Trains others on basic operations such as media preparation, thaw, passage and harvesting
• Identifies, understands and able to explain the ‘why’ of acceptable and unacceptable practices, is able to make on the spot corrections to performance
• Collects, records, reviews, performs analysis, interprets, identifies trends of scientific and process data per good document practices
• Communicates with internal and external stakeholders scientific and process data and recommends path for forward processing
• Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and understands ‘why’ behind the regulations. Able to coach and mentor others to do the same
• Identifies, communicates, addresses and improves simple cGMP compliance and regulatory gaps and issues
• Follows, executes, authors, and improves the efficiency and execution of Standard Operating Procedures (SOPs) and Batch Records (BRs)
• Trains others on SOPs, equipment and all unit operations
• Participates, provides information in the development of and authors basic technical documents such as non-conforming events and deviations
• Possess basic computer skills and able to efficiently use basic Microsoft applications
• Suggests, participates and implements continuous improvement ideas
• Identifies, participates and suggests solutions to technical problems
• Identifies, suggests with options and seeks out for decision making
• Starts to delegate work assignments
• Participates, supports and assists as an SME during regulatory inspections and client audits
• Interacts on an occasional basis with groups that support manufacturing
• Starts to coordinate internally and deal with problems with groups that support manufacturing
• Performs well under direct supervision and works independently on basic tasks and processes

Qualifications:

• High School diploma and over 6 years of relevant experience or
• Associates’/Bachelor’s (science preferred) degree with over 3 years of relevant or equivalent experience

Knowledge / Skills / Abilities:
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• Based on work assignment, may be recommended to have medical testing in accordance with the company’s Occupational Health Program.
• Holiday and shift work often required based on manufacturing schedule as determined by Management.
• Proficient in Oral & Written communication skills
• Need to be able to read, write and understand English
• Proficient in Microsoft (Excel, Word, Outlook)