Scientist 2, Product Development

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 manufacture for clinical manufacturing projects with minimal supervision

• Review manufacturing batch records with minimal supervision. Understand the basics of GMP and IND-enabling formulation strategies

• 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. Clear and accurate record keeping in laboratory notebooks and 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.  Supervisor may not need to attend all meetings

• Other duties as assigned

The Candidate:

• Bachelor’s of Science degree is required plus a minimum of three (3) years of drug product development experience

• We will also accept a Master’s of Science with a minimum of two (2) years of experience in drug product development OR a PhD without any formal industry experience

• Preferred experience with a variety of formulation types: solution, suspension, tablet, capsule, or amorphous intermediate. Spray dried dispersion experience is a plus

• Preferred experience with 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

• 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 $100,000 to $125,000 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, wh