Catalent
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Work Schedule: Monday-Friday, core hours 8am-5pm
100% on-site (San Diego)
Position Summary 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 supports oral and injectable dosage forms, including preformulation testing, formulation and analytical development, cGMP manufacturing, clinical packaging, labeling, and worldwide distribution. Our San Diego location is the home of Catalent Spray Drying technologies with downstream roller compaction capabilities to support challenging compounds.
As the Quality Control (QC) Chemist I, you will perform various analytical techniques and standard lab practices to assess the quality of pharmaceutical products under Good Manufacturing Practices (cGMPs) with limited supervision. This role offers opportunities to broaden analytical understanding and learn common operations in a fast‑paced, early‑phase‑focused 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 patients.
The Role
Independent execution of standard laboratory techniques, including H/UPLC (high‑performance liquid chromatography), dissolution per USP, water‑content analysis per USP, appearance assessment, and water‑activity per USP.
Execution of advanced analytical techniques with assistance such as PXRD (X‑ray diffraction), DSC (Differential Scanning Calorimetry), FT‑IR (infrared spectroscopy), TGA (thermogravimetric analysis), and SEM (scanning electron microscopy).
Independent preparation of samples, solutions, instrument set‑up and breakdown; preparation of data packets and creation of stability data sheets and Certificates of Analysis.
Assisted participation in Out‑of‑Specification investigations and documentation of analytical deviations with Qualified Investigators and management.
Understanding of cGMPs, Catalent SOPs, and Catalent systems; application of ICH and FDA guidance; proactive request for assistance to prevent deviations and investigations.
Participation in technical discussions with supervisor and peers; communication with clients and intra‑company personnel, including delivery of data and notification of OOS/OOT (out‑of‑spec/trend).
Staying current with analytical technology industry standards and equipment; developing skills to interpret data and propose follow‑up actions for investigations and deviations; reviewing data packets for technical and compliance errors.
Other duties as assigned.
The Candidate
Bachelor’s Degree in Chemistry or Biochemistry highly preferred; minimum of a High School Diploma/GED with at least three years of applicable laboratory experience (GMP exposure preferred).
With a Bachelor’s degree, no experience is required; however preference for theoretical understanding of HPLC and other instrumentation listed.
Physical requirements: ability to sit, stand, walk regularly and occasionally lift up to 20 pounds; oral communication skills, use of telephone/email; normal hearing, vision, speaking; good manual dexterity; reasoning ability.
Pay
The anticipated salary range for this role in San Diego, CA is $66,000 – $73,000 annually. Final salary depends on experience, education, and business needs.
Why you should join Catalent
Employee activities and health & wellness programs.
Environmentally friendly green initiatives and community engagement.
Defined career path with annual performance review and feedback.
Employee Resource Groups focusing on Diversity and Inclusion.
Competitive salary with bonus potential; generous 401(k) match and paid time off.
Health benefits effective day one.
152 hours of PTO + 10 paid holidays.
Positive, fast‑paced working environment focused on continuous improvement.
Tuition reimbursement and WellHub program.
Perkspot discounts.
Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation due to a disability, please email DisabilityAccommodations@catalent.com with the job number, title and location.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions does not accept unsolicited resumes from agencies and/or search firms without a valid written & signed search agreement. Resumes submitted to any Catalent employee by a third party become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
Important Security Notice to U.S. Job Seekers: Catalent NEVER requests candidates provide payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process. Please forward fraudulent requests to spam@catalent.com.
California Job Seekers can find our California Job Applicant Notice HERE.
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Get AI-powered advice on this job and more exclusive features.
Work Schedule: Monday-Friday, core hours 8am-5pm
100% on-site (San Diego)
Position Summary 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 supports oral and injectable dosage forms, including preformulation testing, formulation and analytical development, cGMP manufacturing, clinical packaging, labeling, and worldwide distribution. Our San Diego location is the home of Catalent Spray Drying technologies with downstream roller compaction capabilities to support challenging compounds.
As the Quality Control (QC) Chemist I, you will perform various analytical techniques and standard lab practices to assess the quality of pharmaceutical products under Good Manufacturing Practices (cGMPs) with limited supervision. This role offers opportunities to broaden analytical understanding and learn common operations in a fast‑paced, early‑phase‑focused 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 patients.
The Role
Independent execution of standard laboratory techniques, including H/UPLC (high‑performance liquid chromatography), dissolution per USP, water‑content analysis per USP, appearance assessment, and water‑activity per USP.
Execution of advanced analytical techniques with assistance such as PXRD (X‑ray diffraction), DSC (Differential Scanning Calorimetry), FT‑IR (infrared spectroscopy), TGA (thermogravimetric analysis), and SEM (scanning electron microscopy).
Independent preparation of samples, solutions, instrument set‑up and breakdown; preparation of data packets and creation of stability data sheets and Certificates of Analysis.
Assisted participation in Out‑of‑Specification investigations and documentation of analytical deviations with Qualified Investigators and management.
Understanding of cGMPs, Catalent SOPs, and Catalent systems; application of ICH and FDA guidance; proactive request for assistance to prevent deviations and investigations.
Participation in technical discussions with supervisor and peers; communication with clients and intra‑company personnel, including delivery of data and notification of OOS/OOT (out‑of‑spec/trend).
Staying current with analytical technology industry standards and equipment; developing skills to interpret data and propose follow‑up actions for investigations and deviations; reviewing data packets for technical and compliance errors.
Other duties as assigned.
The Candidate
Bachelor’s Degree in Chemistry or Biochemistry highly preferred; minimum of a High School Diploma/GED with at least three years of applicable laboratory experience (GMP exposure preferred).
With a Bachelor’s degree, no experience is required; however preference for theoretical understanding of HPLC and other instrumentation listed.
Physical requirements: ability to sit, stand, walk regularly and occasionally lift up to 20 pounds; oral communication skills, use of telephone/email; normal hearing, vision, speaking; good manual dexterity; reasoning ability.
Pay
The anticipated salary range for this role in San Diego, CA is $66,000 – $73,000 annually. Final salary depends on experience, education, and business needs.
Why you should join Catalent
Employee activities and health & wellness programs.
Environmentally friendly green initiatives and community engagement.
Defined career path with annual performance review and feedback.
Employee Resource Groups focusing on Diversity and Inclusion.
Competitive salary with bonus potential; generous 401(k) match and paid time off.
Health benefits effective day one.
152 hours of PTO + 10 paid holidays.
Positive, fast‑paced working environment focused on continuous improvement.
Tuition reimbursement and WellHub program.
Perkspot discounts.
Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation due to a disability, please email DisabilityAccommodations@catalent.com with the job number, title and location.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions does not accept unsolicited resumes from agencies and/or search firms without a valid written & signed search agreement. Resumes submitted to any Catalent employee by a third party become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
Important Security Notice to U.S. Job Seekers: Catalent NEVER requests candidates provide payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process. Please forward fraudulent requests to spam@catalent.com.
California Job Seekers can find our California Job Applicant Notice HERE.
#J-18808-Ljbffr