Quality Control Chemist I

Quality Control Chemist I

Position Summary:

• Work Schedule: Monday-Friday, core hours 8am-5pm
• 100% on-site (San Diego)

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Catalent’s San Diego facility focuses on early-stage development of small molecule and peptide drug candidates from the bench to the clinic.  This facility offers an array of services that support oral and injectable dosage forms that include preformulation testing, formulation and analytical development, cGMP manufacturing and clinical packaging, labeling, and worldwide distribution.  Our San Diego location is the home of our Catalent Spray Drying technologies with downstream roller compaction capabilities to support the needs of our client’s most challenging compounds.

The Quality Control (QC) Chemist I will be responsible for performing various analytical techniques and common standard lab practices to assess the quality of pharmaceutical products under Good Manufacturing Practices (cGMPs) and limited supervision. This position gives opportunities to broaden analytical understanding and learn the common operations in a fast-paced, early Phase-focused, dynamic Quality Control group. You will be a key member of a multi-site mission to deliver unparalleled service to our clients and quality drug products to the patients.

The Role:

• Independent execution of various standard laboratory techniques, including but not limited to H/UPLC (high performance liquid chromatography), dissolution per USP <711>, water content analysis per USP <921>, appearance assessment, water activity per USP <922>
• Execution of more advanced analytical techniques with assistance such as PXRD (X-ray diffraction), DSC (Differential scanning calorimetry), FT-IR (infrared spectroscopy), TGA (thermogravimetric), and SEM (scanning electron microscopy)
• Independent preparation of samples, solutions, instrument set-up and breakdown. independent preparation of data packets and creation of stability data sheets and Certificates of Analysis to summarize analytical testing
• Assisted participation in Out of Specification investigations and the documentation of analytical deviations along with Qualified Investigators and management
• Understanding of cGMPs, Catalent SOPs and Catalent systems applicable to work performed. Apply ICH and FDA guidance. Proactively request assistance when needed to prevent deviations and investigations
• Participate in technical discussions with supervisor and peers. Communicate with clients and intra-company personnel, including delivery of data and notification of OOS/OOT (out of spec/trend)
• Stay current with analytical technology industry standards and equipment. Begin to develop skills to interpret data and use conclusions to propose follow up actions for investigations and deviations. Begin to develop skills to review data packets for technical and compliance errors and demonstrate appropriate attention to detail
• Other duties as assigned

The Candidate:

• Bachelor’s Degree in Chemistry or Biochemistry highly preferred, but we will accept a minimum of a High School Diploma/GED with a minimum of three years of applicable laboratory experience (GMP exposure preferred)
• With a Bachelor’s degree, no experience is required. However, it is preferred to have a theoretical understanding of HPLC and other instrumentation listed in the job duties
• Physical requirements: Individual may be required to sit, stand, walk regularly and occasionally lift up to 20 pounds; ability to communicate orally with customers, vendors, and co-workers. Regular use of telephone and email. Hearing, vision, and speaking within normal ranges is essential for normal conversations, to receive ordinary information and to prepare or inspect documents. Good manual dexterity for the use of common office equipment such as computer terminals, calculator, copiers, and fax machines. Good reasoning ability is important. Able to understand and utilize management reports, memos, and other documents to conduct business

Pay:

• The anticipated salary range for this role in San Diego, CA is $66,000 - $73,000 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:

• Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel