Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com

In support of manufacturing and support areas, the Assistant Scientist, QC conducts routine general chemical, microbial and/or biological testing of materials and product for release or in-process purposes, in compliance with all applicable procedures and regulations. Performs stability testing and cross testing across group, as required. Validates methods and equipment. Performs a variety of duties related to the efficient and effective functioning of the Quality Control lab.

Conducts routine and non-routine testing of materials and product using a variety of equipment and test methods. Promptly communicates status. Accurately and timely captures data. Promptly enters data into respective system (e.g., LIMS, etc.). Maintains detailed records in compliance with applicable cGMP, safety and environmental requirements. Participates in writing, reviewing and modifying SOPs, protocols and other lab documents as necessary. Maintains routine equipment and instruments. May calibrate equipment as required, ensuring compliance. Performs housekeeping to ensure lab area is continuously maintained in a safe, orderly and compliant condition. Maintains inventory and order materials as required.

Demonstrates ability in testing and methods as required.

May write reports and/or present information to groups, as requested. Demonstrates ability in testing and methods related to department objectives. Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA. Complies with all company and site policies and procedures. Successfully completes regulatory and job training requirements. Makes a positive contribution as demonstrated by: making suggestions for improvement; providing overtime as needed; learning new skills, procedures and processes. Remains current in skills and industry trends. Is available for other duties as required.

Qualifications

Associates Degree in Biology, Biochemistry, Microbiology, Chemistry or other Life Science with 0 – 3 years related experience in biopharmaceutical or pharmaceutical industry is required. Ability to read and interpret documents such as SOPs, operating and maintenance instructions and procedure manuals is required. Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, governmental regulations, common scientific and technical journals and legal documents is required. Ability to write reports, business correspondence and procedure manuals is required. Ability to effectively present information and respond to questions from groups of employees, managers and internal customers is required.

Ability to interpret and carry out an extensive variety of technical instructions in written, oral, mathematical, diagram or schedule form is required. Ability to deal with non-verbal symbolism in its most difficult phases is required. Ability to define problems, collect data, establish facts and draw valid conclusions is required. Ability to deal with problems involving several abstract and concrete variables in standardized situations and in situations where only limited standardization exists is required. Ability to utilize software and customized programs to meet laboratory and business needs is required. Ability to utilize and customize software and troubleshoot to resolve minor software and hardware problems is required.

Ability to calculate figures and amounts such as proportions, percentages, area, circumference, and/or volume and to apply concepts of basic algebra and geometry is required. Must possess solid knowledge of routine and non-routine testing and sampling methods, techniques and related equipment. Excellent knowledge of cGMPs, CFRs is preferred. Advanced knowledge of scientific principles for a wide range of analytical techniques is strongly preferred. This position requires gowning to enter sterile areas. This position is based in Malvern, PA.

Primary Location: North America-United States-Pennsylvania-Malvern
Organization: Janssen Biotech, Inc. (6014)
Job Function: Quality Control

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