Catalent
Position Summary
Work Schedule: Monday‑Friday, core hours 8 am‑4:30 pm. 100% on‑site (San Diego).
Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). Our San Diego facility focuses on early‑stage development of small molecule and peptide drug candidates from bench to clinic. Services include pre‑formulation testing, formulation & analytical development, cGMP manufacturing, clinical packaging, labeling, and worldwide distribution. We house Catalent Spray Drying technologies with downstream roller compaction to support challenging compounds.
The Scientist 3 in the Analytical Development group will independently lead projects with minimal supervision and may supervise 1–2 team members. Responsibilities include development of analytical methods for small molecules, peptides, and amorphous intermediates with a focus on H/UPLC‑UV stability‑indicating methods, assay, dissolution, water content, and physical characterization for oral and injectable products.
The Role
Develop cleaning verification and stability‑indicating methods for peptide and small‑molecule APIs, intermediates, and drug products from scratch.
Perform and train others on analytical techniques, including analytical balances, pH meters, HPLC/UPLC, UV/Vis spectroscopy, GC, USP dissolution apparatus, Karl Fischer, disintegration, Pion µdiss, DSC, TGA, PSD, PXRD, SEM, hardness, and friability testing.
Troubleshoot and optimize methods for characterization of drug products and intermediates. Perform qualification studies to support transfer to Quality Control.
Communicate results internally and externally through oral and written updates, formal reports, and client discussions.
Exercise technical discretion and critical thinking in design, execution, and interpretation of experiments independently.
Assist in creating or revising department‑wide and site‑wide procedures and company SOPs.
Collaborate with Quality Assurance and Quality Control on method validation and compliance issues; collaborate with other departments to troubleshoot technical issues. Familiarity with current GMP regulations is required.
Stay abreast of scientific technologies to maintain state‑of‑the‑art services. Communicate strategy to clients and support business aspects of the position, including billing and proposals.
Other duties as assigned.
Qualifications
Bachelor’s of Science required with a minimum of 4 years of analytical development experience.
Or Master’s of Science with a minimum of 3 years of analytical development experience, or a PhD with at least 1 year of experience.
Familiarity with current GMP regulations.
Proficiency in qualifying analytical test methods for APIs, intermediates, and final drug products, especially HPLC/UPLC stability‑indicating assays, GC, dissolution methods, and water content methods.
Experience in physical characterization techniques such as TGA, DSC, PXRD, GVS, and SEM.
Responsible for developing product‑specific cleaning methods for GMP manufacturing equipment.
Physical requirements: accessible to lab and office staff; vision required for reading documents and computer monitor use.
Pay The anticipated salary range for this role in California is $117,000 to $130,000 annually. Final salary may vary based on experience, education, and business needs.
Benefits
Employee activities: Movie Day, monthly birthday celebrations, Friday bagel breakfast, on‑site fitness center, yoga and HIIT classes, sponsored sports teams, and other company‑sponsored events.
Environmentally friendly initiatives and beach clean‑up activities.
Defined career path, annual performance reviews, and feedback process. Potential for career growth.
Employee Resource Groups focused on Diversity and Inclusion.
Competitive salary with bonus potential; generous 401(k) match; paid time off accrual; medical, dental and vision benefits effective day one.
152 hours of PTO + 10 paid holidays.
Positive fast‑paced environment focusing on continual process improvement.
Tuition reimbursement program.
WellHub program for physical wellness.
Perkspot exclusive discounts from over 900 merchants.
Legal and Equal Opportunity Information Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, submit your request by email to DisabilityAccommodations@catalent.com, including the job number, title and location.
Visit Catalent Careers to explore career opportunities.
California Job Seekers can find our California Job Applicant Notice here.
#J-18808-Ljbffr
Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). Our San Diego facility focuses on early‑stage development of small molecule and peptide drug candidates from bench to clinic. Services include pre‑formulation testing, formulation & analytical development, cGMP manufacturing, clinical packaging, labeling, and worldwide distribution. We house Catalent Spray Drying technologies with downstream roller compaction to support challenging compounds.
The Scientist 3 in the Analytical Development group will independently lead projects with minimal supervision and may supervise 1–2 team members. Responsibilities include development of analytical methods for small molecules, peptides, and amorphous intermediates with a focus on H/UPLC‑UV stability‑indicating methods, assay, dissolution, water content, and physical characterization for oral and injectable products.
The Role
Develop cleaning verification and stability‑indicating methods for peptide and small‑molecule APIs, intermediates, and drug products from scratch.
Perform and train others on analytical techniques, including analytical balances, pH meters, HPLC/UPLC, UV/Vis spectroscopy, GC, USP dissolution apparatus, Karl Fischer, disintegration, Pion µdiss, DSC, TGA, PSD, PXRD, SEM, hardness, and friability testing.
Troubleshoot and optimize methods for characterization of drug products and intermediates. Perform qualification studies to support transfer to Quality Control.
Communicate results internally and externally through oral and written updates, formal reports, and client discussions.
Exercise technical discretion and critical thinking in design, execution, and interpretation of experiments independently.
Assist in creating or revising department‑wide and site‑wide procedures and company SOPs.
Collaborate with Quality Assurance and Quality Control on method validation and compliance issues; collaborate with other departments to troubleshoot technical issues. Familiarity with current GMP regulations is required.
Stay abreast of scientific technologies to maintain state‑of‑the‑art services. Communicate strategy to clients and support business aspects of the position, including billing and proposals.
Other duties as assigned.
Qualifications
Bachelor’s of Science required with a minimum of 4 years of analytical development experience.
Or Master’s of Science with a minimum of 3 years of analytical development experience, or a PhD with at least 1 year of experience.
Familiarity with current GMP regulations.
Proficiency in qualifying analytical test methods for APIs, intermediates, and final drug products, especially HPLC/UPLC stability‑indicating assays, GC, dissolution methods, and water content methods.
Experience in physical characterization techniques such as TGA, DSC, PXRD, GVS, and SEM.
Responsible for developing product‑specific cleaning methods for GMP manufacturing equipment.
Physical requirements: accessible to lab and office staff; vision required for reading documents and computer monitor use.
Pay The anticipated salary range for this role in California is $117,000 to $130,000 annually. Final salary may vary based on experience, education, and business needs.
Benefits
Employee activities: Movie Day, monthly birthday celebrations, Friday bagel breakfast, on‑site fitness center, yoga and HIIT classes, sponsored sports teams, and other company‑sponsored events.
Environmentally friendly initiatives and beach clean‑up activities.
Defined career path, annual performance reviews, and feedback process. Potential for career growth.
Employee Resource Groups focused on Diversity and Inclusion.
Competitive salary with bonus potential; generous 401(k) match; paid time off accrual; medical, dental and vision benefits effective day one.
152 hours of PTO + 10 paid holidays.
Positive fast‑paced environment focusing on continual process improvement.
Tuition reimbursement program.
WellHub program for physical wellness.
Perkspot exclusive discounts from over 900 merchants.
Legal and Equal Opportunity Information Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, submit your request by email to DisabilityAccommodations@catalent.com, including the job number, title and location.
Visit Catalent Careers to explore career opportunities.
California Job Seekers can find our California Job Applicant Notice here.
#J-18808-Ljbffr