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Scientist 1, Analytical Development - San Diego California
Company: Catalent Pharma Solutions
Location: San Diego, California
Posted On: 11/17/2024
Scientist 1, Analytical DevelopmentPosition Summary:Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.Catalent Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best.Catalent Pharma Solutions is hiring a Scientist 1, Analytical Development for our San Diego, CA team. This is a great opportunity to gain hands-on industry experience and learn a variety of lab techniques. The Scientist 1 will be expected to understand and execute basic analytical procedures in order to assess the quality of pharmaceutical API (active pharmaceutical ingredient), intermediates, and final drug products under limited supervision. Duties may include the preparation of simple aqueous and organic buffered solutions, volumetric dilution of samples and standards using good laboratory techniques, clear and accurate record keeping in laboratory notebooks, use of analytical instrumentation to acquire raw data, calculation and reporting of final results. The Scientist 1 will begin to develop product-specific cleaning methods to support use of GMP (Good Manufacturing Practices) manufacturing equipment. All duties will be performed in compliance with company standard operating procedures (SOPs) and GMP regulations, as appropriate.This is a full-time position: Monday - Friday, 8am-5pm on-site.The Role: - Perform and train others on a variety of analytical techniques including, but not necessarily limited to: analytical balances, pH meters, high performance liquid chromatography (HPLC/UPLC), GC (gas chromatography), DSC (Differential scanning calorimetry), TGA (thermogravimetric), PXRD (X-ray diffraction), SEM (scanning electron microscopy), GVS, UV/Vis spectroscopy, USP dissolution testing apparatus, disintegration, hardness, friability, and moisture analysis by Karl Fischer.
- Develop cleaning verification methods, execution of excipient compatibility and forced degradation studies, under supervision.
- Troubleshoot and optimize analytical methods for characterization of drug products and intermediates. Perform qualification studies to determine if methods are suitable for transfer to Quality Control. Simple experimental design and execution will be performed independently.
- Data interpretation should be conducted with limited guidance. Individuals will be able to identify key factors from data and understand the importance of the findings.
- Clear and accurate record keeping in laboratory notebooks and some secondary review of other colleagues' work for scientific accuracy and compliance. Comply with good housekeeping and safety practices.
- Increase in client interaction will be a focus. Individuals may lead discussions with clients on technical topics relating to their project. Individuals should have a good general foundation of scientific principles, chemistry concepts, and be proficient in core analytical scientific techniques, GMPs, and technical writing.
- Individuals will propose solutions to supervisor for most scientific problems and may be invited to supervise laboratory assistant(s).
- Other duties as assigned.The Candidate:
- Bachelor's degree in a scientific discipline is required plus a minimum of one year of experience in analytical development. We will also accept a Master's degree with no formal industry experience, although you must have a detailed theoretical understanding of drug development.
- Must become proficient in a variety of analytical techniques including, but not necessarily limited to, analytical balances, pH meters, high performance liquid chromatography (HPLC/UPLC), GC (gas chromatography), DSC (Differential scanning calorimetry), TGA (thermogravimetric), PXRD (X-ray diffraction), SEM (scanning electron microscopy), GVS, UV/Vis spectroscopy, USP dissolution testing apparatus, disintegration, hardness, friability, and moisture analysis by Karl Fischer.
- Candidate must also be highly detail-oriented and organized, able to work both independently and as a team player with a positive attitude. Must demonstrate excellent communication, critical thinking, and organizational skills.
- Physical Requirements: On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds. Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently.Pay:
- The anticipated salary range for this role in San Diego, CA is $74,000 - $78,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.Why you should join Catalent:
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