Catalent, Inc.
Contract Development and Manufacturing Organization (CDMO)
Scientist2,ProductDevelopment
Neural analysis suggests this role is
optimal for Mid candidates.
“Scientist 2, Product Development at Catalent, Inc.. Skills: formulation development, analytical techniques, drug product development. support formulation development of drug candidates for preclinical and human clinical studies. develop timelines and plan series of experiments for solid oral drug products, spray dried products, injectables, and amorphous dispersions”
What You'll Achieve.
deliver unparalleled service to our clients and quality drug products to the patients
Industry & Context.
Exercise technical discretion and critical thinking in the design, execution and interpretation of experiments independently; Data interpretation should be conducted with guidance on complex issues only
100% on-site (San Diego), 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
What They're Looking For.
Must Have
Bachelor's of Science degree plus a minimum of three (3) years of drug product development experience, fundamental understanding of regulatory guidelines for the chemistry, manufacturing, and controls (CMC) of drug products, basics of GMP and IND-enabling formulation strategies
Nice to Have
Master's of Science with a minimum of two (2) years of experience in drug product development, PhD without any formal industry experience, variety of formulation types: solution, suspension, tablet, capsule, or amorphous intermediate, Spray dried dispersion experience, analytical techniques such as pH, osmolality, viscosity, particle size, DSC (Differential scanning calorimetry), PXRD (X-ray diffraction), SEM (scanning electron microscopy), TGA (thermogravimetric), DVS, powder characterization, dissolution, disintegration, spectrophotometry, and chromatography
What You'll Do.
support formulation development of drug candidates for preclinical and human clinical studies
develop timelines and plan series of experiments for solid oral drug products
and amorphous dispersions
conduct and/or supervise the execution of formulation studies for drug candidates in the form of a solution
or amorphous intermediates
perform analytical techniques
develop strategic experimental plans and timelines
collaborate with other departments to oversee scale-up and manufacture for clinical manufacturing projects with minimal supervision
review manufacturing batch records with minimal supervision
exercise technical discretion and critical thinking in the design
execution and interpretation of experiments independently
clear and accurate record keeping in laboratory notebooks
secondary review of other colleagues’ work for scientific accuracy and compliance
primary responsibility for individual client projects with strategic support from supervisor
lead discussions with clients on technical topics relating to their project
How You'll Work.
Team & Collaboration
Collaborate with other departments to oversee scale-up and manufacture for clinical manufacturing projects; secondary review of other colleagues’ work for scientific accuracy and compliance; strategic support from supervisor; lead discussions with clients on technical topics relating to their project
Communication Scope
Lead discussions with clients on technical topics relating to their project
Process & Methodology
develop timelines, plan series of experiments, strategic experimental plans and timelines, oversee scale-up and manufacture for clinical manufacturing projects, Primary responsibility for individual client projects
Full Job Description
**Scientist 2, Product Development** **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 Scientist 2 in Product Development will support formulation development of drug candidates for preclinical and human clinical studies. You will develop timelines and plan series of experiments for solid oral drug products, spray dried products, injectables, and amorphous dispersions. This individual must have a fundamental understanding of regulatory guidelines for the chemistry, manufacturing, and controls (CMC) of drug products. 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:** * Conduct and/or supervise the execution of formulation studies for drug candidates in the form of a solution, suspension, tablet, capsule, or amorphous intermediates * Perform analytical techniques such as pH, osmolality, viscosity, particle size, DSC (Differential scanning calorimetry), PXRD (X-ray diffraction), SEM (scanning electron microscopy), TGA (thermogravimetric), DVS, powder characterization, dissolution, disintegration, spectrophotometry, and chromatography * Develop strategic experimental plans and timelines. Collaborate with other departments to oversee scale-up and ma
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