Manufacturing Associate III

3 months ago

Philadelphia, United States WuXi AppTec Full time

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)

Our Values:

Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.

Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.

WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

  • Manufacturing Associate III

    1 week ago

    Philadelphia, Pennsylvania, United States WuXi AppTec Full time

    Job SummaryWe are seeking a highly skilled and experienced Manufacturing Associate III to join our team at WuXi AppTec. As a key member of our production team, you will be responsible for the manufacture of Master and Working Cell Banks and performing activities within production facilities to support the manufacture of Cell & Gene Therapy products, and...

  • Aseptic Manufacturing Technician I/II/III

    1 month ago

    Philadelphia, United States Planet Pharma Full time

    CONTRACT MUST HAVES:Bachelor's degree or some post-secondary education and 1 year of GMP cell or gene therapy manufacturing experienceOverview:The Aseptic Manufacturing Technician I/II/III role is crucial for the autologous cell therapy manufacturing program. This position requires a broad understanding of theories, techniques, and principles to support...

  • Aseptic Manufacturing Technician I/II/III

    1 week ago

    Philadelphia, United States Planet Pharma Full time

    CONTRACT MUST HAVES:Bachelor's degree or some post-secondary education and 1 year of GMP cell or gene therapy manufacturing experienceOverview:The Aseptic Manufacturing Technician I/II/III role is crucial for the autologous cell therapy manufacturing program. This position requires a broad understanding of theories, techniques, and principles to support...

  • Manufacturing Associate

    1 week ago

    Philadelphia, United States WuXi AppTec Full time

    The Manufacturing Associate I is 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• Able to...

  • Manufacturing Associate

    1 week ago

    Philadelphia, United States WuXi AppTec Full time

    The Manufacturing Associate I is 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• Able to...

  • Manufacturing Engineer III

    3 months ago

    Philadelphia, United States Cardone Industries Full time

    Company Overview Since 1970, we here at CARDONE have been fixing what fails in the automotive industry. Our success has been fueled by our commitment to building better parts—and better partnerships.  We’re more than just an auto parts manufacturer: we rethink and remanufacture parts to outperform OE standards for reliability. This not only means...

  • Manufacturing Associate II

    1 month ago

    Philadelphia, Pennsylvania, United States Actalent Full time

    Job Title: Manufacturing Associate IIJob DescriptionResponsible for manufacturing Master and Working Cell Banks and performing activities within production facilities to support the manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).Hard Skills Cell Culture Aseptic Technique GMP...

  • Manufacturing Associate, Cell

    6 days ago

    Philadelphia, United States Proclinical Full time

    Manufacturing Associate, Cell and Gene Therapy - Contract - Philadelphia PA Proclinical is seeking a dedicated Manufacturing Associate for Cell and Gene Therapy. Primary Responsibilities:This role focuses on the manufacturing of Master and Working Cell Banks and performing activities within production facilities to support the manufacture of Cell & Gene...

  • Manufacturing Associate, Cell

    4 weeks ago

    Philadelphia, United States Proclinical Staffing Full time

    Manufacturing Associate, Cell and Gene Therapy - Contract - Philadelphia PA Proclinical is seeking a dedicated Manufacturing Associate for Cell and Gene Therapy. Primary Responsibilities:This role focuses on the manufacturing of Master and Working Cell Banks and performing activities within production facilities to support the manufacture of Cell & Gene...

  • Manufacturing Associate, Cell

    4 weeks ago

    Philadelphia, United States Proclinical Staffing Full time

    Manufacturing Associate, Cell and Gene Therapy - Contract - Philadelphia PA Proclinical is seeking a dedicated Manufacturing Associate for Cell and Gene Therapy. Primary Responsibilities:This role focuses on the manufacturing of Master and Working Cell Banks and performing activities within production facilities to support the manufacture of Cell & Gene...

  • Senior Manufacturing Associate

    7 days ago

    Philadelphia, Pennsylvania, United States WuXi AppTec Full time

    Job Summary:We are seeking a highly skilled Manufacturing Technician to join our team at WuXi AppTec. As a key member of our production team, you will be responsible for the manufacture of Master and Working Cell Banks, supporting the production of Cell & Gene Therapy products, and final product fills in accordance with cGMPs.Key Responsibilities:Apply...

  • Aseptic Manufacturing Technician

    1 week ago

    Philadelphia, United States Planet Pharma Full time

    Titles: Aseptic Manufacturing Technician II/III/Sr./LeadsShifts: 1st, 2nd, & 3rd shift openings (Sunday to Wednesday or Wednesday to Saturday schedule)Type: 6 month contract to hire Pay: $31 to $40 per (depending on years of experience) Specific ResponsibilitiesDevelop a comprehensive understanding of and be able to proficiently execute Iovance’s current...

  • Aseptic Manufacturing Technician

    1 week ago

    Philadelphia, United States Planet Pharma Full time

    Titles: Aseptic Manufacturing Technician II/III/Sr./LeadsShifts: 1st, 2nd, & 3rd shift openings (Sunday to Wednesday or Wednesday to Saturday schedule)Type: 6 month contract to hire Pay: $31 to $40 per (depending on years of experience) Specific ResponsibilitiesDevelop a comprehensive understanding of and be able to proficiently execute Iovance’s current...

  • Maintenance Director

    2 months ago

    Philadelphia, United States Vestal Manufacturing Full time

    Job DescriptionJob DescriptionLocated in Sweetwater, TN - Relocation Package AvailableFor over 65 years, Vestal Manufacturing has provided quality USA-made gray iron castings to our customers. American craftsmanship and technology, backed by a focus on quality, are integral parts of any Vestal casting. Our goal is to produce superior products on a timely...

  • Associate Director, External Manufacturing

    7 days ago

    Philadelphia, Pennsylvania, United States InsideHigherEd Full time

    About the Role:The Gene Therapy Program at InsideHigherEd is seeking a highly experienced Associate Director, External Manufacturing to lead the development of external Chemistry Manufacturing Control (CMC) project plans for our programs. As a key member of our team, you will be responsible for developing and implementing strategies to ensure the successful...

  • Lead Cell

    2 months ago

    Philadelphia, United States Proclinical Staffing Full time

    Proclinical is seeking a Lead Manufacturing Associate who will be responsible for the production of M&W Cell Banks. The role also involves supporting the manufacturing of Cell & Gene Therapy products and final product fills in accordance with current Good Manufacturing Practices (cGMPs).Please note that to be considered for this role you must have the right...

  • Manufacturers Outside Sales Representative

    2 months ago

    Philadelphia, United States Bruske Products Full time

    Job DescriptionJob DescriptionManufacturers Outside Sales RepresentativeSUMMARY:This position is responsible for opening new accounts while maintaining strong relationships with existing customers in Philadelphia. As we transition our benefits and technology stack, you will receive support from our management team, including guidance from a former top sales...

  • Associate Aseptic Manufacturing Technician

    3 months ago

    Philadelphia, United States Iovance Biotherapeutics Inc Full time

    Job DescriptionJob DescriptionSalary:  OverviewThe Associate Aseptic Manufacturing Technician is an entry-level position for our autologous cell therapy manufacturing program. As an Associate Aseptic Manufacturing Technician, you will be responsible for learning and completing various tasks, such as cleaning, sanitization, preparation, and the process for...

  • Manufacturing Instructor

    2 weeks ago

    Philadelphia, United States Philadelphia Technician Training Institute Full time

    Job DescriptionJob DescriptionPhiladelphia Technician Training Institute (PTTII) seeks an individual to serve as a Manufacturing Instructor at our Berean campus. Successful applicants will be tasked with must ensuring program graduates are professionally prepared as manufacturing technicians. PTTI's graduates must be capable of making significant...

  • Manufacturing Instructor

    3 months ago

    Philadelphia, United States Philadelphia Technician Training Institute Full time

    Job DescriptionJob DescriptionPhiladelphia Technician Training Institute (PTTII) seeks an individual to serve as a Manufacturing Instructor at our Berean campus. Successful applicants will be tasked with must ensuring program graduates are professionally prepared as manufacturing technicians. PTTI's graduates must be capable of making significant...