Manufacturing Associate III

4 weeks 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.

  • Research Associate III

    2 weeks ago

    Philadelphia, United States Drexel University Full time

    Research Associate IIIJob no: 503034 Work type: Full-Time Location: Center City - Philadelphia, PA Categories: College of MedicineJob Summary The Department of Pharmacology and Physiology is looking for an experienced Research Associate to support NIH-funded research activities within the Meucci lab. Ongoing projects focus on neurocognitive disorders...

  • Manufacturing Engineer III

    3 weeks 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...

  • Senior Cell Manufacturing Associate

    3 weeks ago

    Philadelphia, Pennsylvania, United States Proclinical Full time

    Senior Cell Manufacturing Associate - Contract - OnsiteProclinical Staffing is seeking a Senior Cell Manufacturing Associate to join a cutting-edge biotech company. This is a contract role located in Philadelphia, PA.Skills & Requirements:Bachelor's degree or some post-secondary education.3+ years of experience in biopharmaceutical based GMP manufacturing...

  • Manufacturing Associate I

    3 weeks ago

    Philadelphia, Pennsylvania, United States WuXi AppTec Inc 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 • Able to operate and maintain...

  • Biopharmaceutical Manufacturing Associate

    5 days ago

    Philadelphia, United States Blue Ocean Full time

    **Overview**: 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. **Responsibilities**: - Develop a comprehensive understanding of and be able to proficiently execute current cell therapy manufacturing...

  • Additive Manufacturing Engineer

    7 days ago

    Philadelphia, United States ARCH Full time

    The Additive Manufacturing Engineer will engage in product development, manufacturing, process and system enhancement, sales support, and various activities associated with the growing business of additive manufacturing. Essential Duties and Responsi Manufacturing Engineer, Engineer, Manufacturing, Product Development

  • Manufacturing Instructor

    6 days 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 Supervisor

    13 hours ago

    Philadelphia, United States WuXi AppTec Full time

    Responsible for providing supervision in the cleaning and sanitization of GMP space and associated areas that manufacture Master and Working Cell Banks, within production facilities that manufacture Cell & Gene Therapy products and final product fills according to current Good Manufacturing Practices (cGMPs). This is a night shift opportunity.  The hours...

  • Manufacturing Instructor

    7 days ago

    Philadelphia, Pennsylvania, 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 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...

  • Director of Manufacturing

    4 weeks ago

    Philadelphia, United States AllStar Staffing Group Full time

    We have an immediate opening for a Director of Manufacturing at leading company conveniently located in Philadelphia. This is a full time direct hire opportunity.Job Duties Include:Manages all production activities for a three-shift operation. Manages union and temporary labor workforce.Writes and manages production and production schedules. Writes and...

  • Manufacturing Technician

    3 weeks ago

    Philadelphia, United States R&D Partners Full time

    Job DescriptionJob DescriptionSpecific ResponsibilitiesDevelop a comprehensive understanding of and be able to proficiently execute 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...

  • Supervisor Manufacturing Support Services

    13 minutes ago

    Philadelphia, United States WuXi AppTec Full time

    Responsible for providing supervision in the cleaning and sanitization of GMP space and associated areas that manufacture Master and Working Cell Banks, within production facilities that manufacture Cell & Gene Therapy products and final product fills according to current Good Manufacturing Practices (cGMPs). This is a night shift opportunity.  The hours...

  • Director of Manufacturing

    3 weeks ago

    Philadelphia, United States Frankford Candy Full time

    Frankford Candy is the nations largest distributor and manufacturer of licensed candy and gifting. We manufacture chocolate in our Philadelphia headquarters and partner with international factories to produce high quality and great tasting confections and gift products for everyday and seasonal occasions. Our licensors are the best in the industry including...

  • Director of Manufacturing

    4 weeks ago

    Philadelphia, United States Frankford Candy LLC Full time

    Frankford Candy is the nation’s largest distributor and manufacturer of licensed candy and gifting. We manufacture chocolate in our Philadelphia headquarters and partner with international factories to produce high quality and great tasting confections and gift products for everyday and seasonal occasions. Our licensors are the best in the industry...

  • Director of Manufacturing

    4 weeks ago

    Philadelphia, United States Frankford Candy LLC Full time

    Frankford Candy is the nation’s largest distributor and manufacturer of licensed candy and gifting. We manufacture chocolate in our Philadelphia headquarters and partner with international factories to produce high quality and great tasting confections and gift products for everyday and seasonal occasions. Our licensors are the best in the industry...

  • Operations Associate

    1 week ago

    Philadelphia, United States Sephora Full time

    Job ID: 246366 Store Name/ Number: PA-Chestnut St (0294) Address: 1714 Chestnut Street, Philadelphia, PA 19103, United States (US) Hourly/ Salaried: Hourly (Non-Exempt) Full Time/ Part Time: Part Time Position Type: Regular Operations Associate It ta Operations Associate, Operations, Associate, Operation, Manufacturing, Retail

  • Nacdd Pha-illinois Iii

    14 hours ago

    Philadelphia, United States AmeriCorps Full time

    The National Association of Chronic Disease Directors (NACDD) is a national public health non-profit agency focused on the health of the public by strengthening state and national leadership and expertise for chronic disease prevention and control. NACDD’s core membership is composed of the 58 State and Territorial Health Department Chronic Disease...

  • Manufacturing Supervisor

    14 hours ago

    Philadelphia/PA/US WuXi AppTec Full time

    Responsible for providing supervision in the cleaning and sanitization of GMP space and associated areas that manufacture Master and Working Cell Banks, within production facilities that manufacture Cell & Gene Therapy products and final product fills according to current Good Manufacturing Practices (cGMPs). This is a night shift opportunity.  The hours...

  • Manufacturing Technician

    5 days ago

    Philadelphia, United States AstraZeneca Full time

    **Essential Skills/Experience**: - High school diploma or general education degree (GED) or Biologic Technician Certification or Associate Science Degree. - Minimum 1 year of related experience or training. **Desirable Skills/Experience**: - Bachelor’s degree. - Aseptic processing experience in the bio/pharmaceutical industry. - Clean room work...