QC Chemist I

QC Chemist I

Position Summary:

• Work Schedule: Monday-Friday, core hours 8am-4:30pm

• 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 QC Chemist I is responsible for performing various analytical techniques and common standard lab practices in order to assess the quality of pharmaceutical products under cGMPs (as applicable) and limited supervision. This entry level position gives opportunities to broaden analytical understanding and learn the common operations in a fast-paced, early Phase-focused, dynamic Quality Control group.

The Role:

• Independent execution of various standard laboratory techniques, including but not limited to H/UPLC, 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, DSC, FT-IR, TGA, and SEM.

• 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 cGMP, Catalent SOPs and Catalent systems applicable to work performed. Understand and apply ICH and FDA guidance.

• Communicate with clients and intra-company personnel, including delivery of data and notification of OOS/OOT.

• Other duties as assigned

The Candidate:

• Bachelors of Science in a scientific discipline (Chemistry or biochemistry preferred).

• Applicable laboratory experience and some GMP exposure preferred.

• Physical Requirements: Individual needs to be accessible to lab and office staff and able to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently

Pay:

• The anticipated salary range for this role in California is $68,000 - $71,000 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 Breakfast, On-site Fitness Center with machines, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment.

• Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement.

• Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.  

• Several Employee Resource Groups focusing on Diversity and Inclusion.

• Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. 

• 152 hours of PTO + 10 paid holidays.

• Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic.

• Tuition Reimbursement – Let us help you finish your degree or earn a new one!

• WellHub program to promote overall physical wellness.

• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide arr