Pharmaceutical Manufacturing Specialist

2 weeks ago


Cranbury, New Jersey, United States Experic Full time
Job Overview

Experic is a premier contract development and manufacturing organization (CDMO) specializing in clinical trial supply services. Our mission is to provide innovative and scalable solutions throughout every stage of a product's life cycle, from clinical trials to commercial production. We pride ourselves on our advanced pharmaceutical manufacturing, packaging, and labeling technologies, which cater to a diverse range of dosing and packaging formats. Our commitment to precision, state-of-the-art filling equipment, and Class A regulatory compliant cGMP facilities sets us apart in the industry.


We are dedicated to cultivating a team culture rooted in trust, integrity, ethical practices, and compliance, with a steadfast focus on delivering high-quality outcomes. If you thrive in a collaborative environment and are motivated by the chance to make a significant impact, you will find a rewarding career at Experic. We are committed to fostering a respectful workplace that promotes open communication and continuous improvement, allowing you to engage in meaningful work and grow both professionally and personally.


Key Responsibilities:

  • Operate pharmaceutical manufacturing equipment within a GMP setting to produce clinical supplies and conduct development experiments.
  • Lead manufacturing operations in designated production areas.
  • Adhere to and comprehend all policies and procedures at Experic, including regulatory, safety, SOPs, and work instructions.
  • Assist in the creation of new processes and procedures under management supervision, including:
    • Becoming a subject matter expert on pharmaceutical manufacturing equipment.
    • Translating equipment knowledge into new SOPs and work instructions, and aiding in training additional staff.
    • Providing frontline troubleshooting for processes and equipment.
  • Conduct pharmaceutical manufacturing tasks such as:
    • Batch documentation and record generation.
    • Material sampling, staging, dispensing, and returns.
    • Setting up, operating, and cleaning pharmaceutical equipment and rooms.
    • Utilizing appropriate personal safety equipment and engineering controls.
    • Performing in-process inspections and sampling.
    • Engaging with the Experic IT platform.
  • Support developmental manufacturing experiments as directed by management.
  • Assist in investigational and quality systems activities.
  • Collaborate with maintenance teams on preventative maintenance, troubleshooting, and equipment repairs.
  • Participate in continuous improvement initiatives at Experic.

Additional Requirements:

  • Ensure compliance with all federal and state regulations and guidelines.
  • Adhere to all company and site policies and procedures.
  • Demonstrate mechanical aptitude and a willingness to explore complex machinery and learn new processes.
  • Maintain self-direction on tasks that are both well-defined and exploratory.
  • Stay current with professional and industry trends.
  • Contribute positively by suggesting improvements and acquiring new skills and procedures.
  • Be available for additional duties and overtime as necessary.

Qualifications:

Requires a bachelor's degree in an Engineering or Scientific field with three years of experience in the Pharmaceutical or Life Sciences sector, or a High School Diploma with seven years of experience in Pharmaceutical manufacturing, particularly in implementing new equipment and processes.

Skills:

  • Ability to read and interpret documents such as SOPs, manuals, and specifications.
  • Clear communication skills, both written and oral.
  • Proficiency in basic arithmetic and data analysis.
  • Strong reasoning abilities, including scientific and deductive reasoning.
  • Knowledge of cGMP and familiarity with Pharmaceutical Manufacturing.
  • Computer proficiency for data entry and word processing.

Physical Demands:

  • Frequent standing, walking, and using hands for various tasks.
  • Occasional sitting and reaching.
  • Ability to lift and/or move up to 50 pounds.
  • Specific vision abilities required include close vision and depth perception.


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