Quality Control Chemist I

Catalent Pharma Solutions•San Diego, CA

12d•$66,000 - $73,000•Onsite

About The Position

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

Requirements

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

Responsibilities

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

Benefits

Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, 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 array of categories.
Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.
Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.
Join us in making a difference. personal initiative. dynamic pace. meaningful work.