Lubrizol Production Supervisor - Clinical Production in Bethlehem, Pennsylvania

Production Supervisor - Clinical Production

REQ ID: 35161

Particle Sciences, A Lubrizol Company is the leading CDMO for complex formulation development for the pharmaceutical industry, with over 20 years of successful experience and a solid base of clients ranging from the world’s largest pharmaceutical and biotech companies to small VC backed start-ups. As a member of the Particle Sciences, Inc. team, you will be working for a company that is engaged in important, exciting, and socially relevant projects. Particle Sciences is a fast-paced environment that features a variety of projects, technical challenges, and opportunities for growth. To learn more about Particle Sciences, A Lubrizol Company, visit www.particlesciences.com and https://www.lubrizol.com/Life-Sciences .

Particle Sciences, Inc. in Bethlehem, PA has an immediate opening for a Production Supervisor – Clinical Production.

Essential Duties and Responsibilities

  • Provide fundamental support and supervision for cGMP clinical pharmaceutical manufacturing (Aseptic and Non-Sterile environments), ensuring manufacturing equipment is clean, calibrated and functionally set up in the manufacturing rooms.

  • Provide technical assistance to formulators in development/scale up work for GMP process.

  • Develop and revise GMP documentation (master batch records, cleaning validation, risk assessments, etc.).

  • Execute production batch records for clinical supplies manufacturing.

  • Clean and maintain production suites and equipment.

Knowledge, Skills and Abilities

  • HS degree or higher, with education or training in a scientific field

  • At least 5 years of related experience in pharmaceutical or biopharmaceutical manufacturing or equivalent combination of education and experience with knowledge of current Good Manufacturing Practices (cGMP)

  • Supervisory experience preferred

  • Practical knowledge of cGMPs, GLP, and FDA/ICH guidelines and their application to drug development and production

  • Technical expertise in the scale up of processes from development to GMP is required

  • Aseptic production/filling experience is required

  • Experience with a broad range of dosage forms such as tablets, capsules, device/implants, solutions, suspensions, emulsions, lyophilized products, and novel formulation types is preferred

  • Proficiency with common PC based applications and specifically in the use of MS Office

  • General computer proficiency, an understanding of corporate IT networks, or familiarity with electronic data system compliance (Part 11, data integrity, etc) would be desirable skills

  • Knowledge of laboratory safety precautions and protocols for safe handling and the disposal of hazardous agents/reagents, chemicals and materials

  • Excellent organizational, communication and analytical skills

  • Ability to understand and effectively communicate technical and business information, both oral and written to others, including co-workers, supervisors, subordinates, clients, and vendors

  • Ability to define problems, collect data, establish facts, and draw valid conclusions

  • Ability to follow written and verbal directions

  • Ability to work with materials / compounds considered as high potent

  • Ability to work varied and extended hours/days, as business dictates

Particle Sciences’ headquarters is located in Bethlehem, PA, part of the Lehigh Valley region of Pennsylvania. Lehigh Valley includes the cities of Allentown at http://www.visitpa.com/cities/allentown , Bethlehem at http://www.visitpa.com/cities/bethlehem and Easton at http://www.visitpa.com/cities/easton . The region is slightly over an hour to both Philadelphia and New York City, which places you right in the action. Buzzing with business, culture, knowledge and entertainment, the Lehigh Valley is a vibrant place for people of all ages and walks of life to live, learn, work and play. This region offers a little bit of everything for everyone - ethnically-diverse communities, affordable housing, award-winning schools and universities, world-class healthcare, ski resorts, museums, casinos, shopping, restaurants, sports and nightlife. From the yearly Musikfest at http://www.musikfest.org/ festival, to skiing in the Poconos at https://www.poconomountains.com/ , to hiking or biking through the many state parks, you can make it happen right here in the Lehigh Valley at http://www.visitpa.com/regions/lehigh-valley .

Lubrizol is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.

Nearest Major Market: Allentown

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