Lubrizol Operations Manager in Bethlehem, Pennsylvania

Operations Manager

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 Operations Manager for Commercial Manufacturing.

Essential Duties and Responsibilities

  • Manage daily operations in commercial manufacturing, including providing supervision for production personnel engaged in manufacture of commercial drug products and maintenance of commercial facility.

  • Participate in equipment and facility qualification and validations as needed.

  • Participate in process validations and commercial batch manufacturing as needed.

  • Review Master Batch Records, Standard Operating procedures, Qualification/Validation protocols and reports, calibration reports, and other essential cGMP documents.

  • Manage batch activities and review executed production batch records. Where necessary, execute production batch records during manufacture of commercial drug products.

  • Assist in production planning process, including sourcing and purchasing.

  • Provide training and ensure all subordinates have appropriate training.

  • Maintain awareness of inventory for consumable and packaging goods used in manufacturing. Develop and manage vendor relationships as needed. Provide oversight of ordering, organization and stocking in manufacturing areas, as appropriate.

  • Write and revise Standard Operating Procedures and other operational documents, as needed.

  • Assist with performance of qualification and validation studies; ensure all equipment, systems and manufacturing areas are maintained in a current qualified state.

  • Maintain and troubleshoot equipment as an equipment owner, where appropriate.

  • Other duties, as assigned by area management.

Knowledge, Skills and Abilities

  • In-depth knowledge of cGMPs and working in a regulated environment following QbD, cGMP and SOPs is required.

  • Hands-on experience with clinical and/or commercial manufacturing is required.

  • Hands-on experience with sterile dosage forms and aseptic processing is required.

  • Hand-on experience with multiple delivery forms is desired (semisolids, solids, liquids, suspensions, including sterile and non-sterile).

  • Experience writing and developing SOPs, IQ/OQ/PQ protocols, and other regulatory documentation is required.

  • BS/PharmD in Pharmacy, Engineering or related discipline, with a minimum of 10 years of experience in the pharmaceutical or related industry, with at least 5 years of experience in drug product manufacture, is required.

  • Supervisory experience is required.

  • Mechanical aptitude is preferred.

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

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

  • Excellent organization, communication and analytical skills are required.

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

  • Intermediate mathematical skills, including: algebraic functions, statistics (mean, median, standard deviation, variance, probability), basic geometry (area, volume calculations), and scientific calculators are required.

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

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 sex, race, color, national origin, citizenship, age, religion, marital status, military service, sexual orientation, genetic information, gender identity, or any other characteristic or trait protected by federal, state, or local law.

Nearest Major Market: Allentown

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