Senior Scientist, Product Development

Senior Scientist, 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.

This is a very cross-functional position which will lead projects as an individual or build a team focused on oral formulation development for small molecules or peptide drug products and amorphous intermediates. The primary formulation platforms will include tablets, capsules, granules, beads, solutions, suspensions, immediate or extended-release dosage forms, and amorphous intermediates.  The individual will research and introduce new formulation technology to produce and characterize drug products and will be the primary point of customer contact for formulation strategy, compliance, and troubleshooting. 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:

• Creates and develops innovative drug formulations using the techniques described above. Has a thorough understanding Good Manufacturing Practice (GMP) and Investigational New Drug (IND-enabling) formulation strategies. Selects and evaluates container/closure systems and storage conditions with limited supervision
• Performs and trains others on a variety of formulation techniques including, but not necessarily limited to: blending, encapsulation, suspensions, solutions, wet/dry/fluid bed granulation, tablet compression, coating, milling, spray drying. Performs and trains others on a variety of characterization techniques (such as pH, osmolality, viscosity, particle size, DSC, PXRD, SEM, TGA, DVS, powder characterization, dissolution, disintegration, spectrophotometry, and chromatography)
• Independently responsible for the successful transfer of formulation projects to the GMP manufacturing team and for collaboration with process engineering team during technology transfer. Responsible for transfer of projects to external manufacturers, or late stage/commercial manufacturing sites within Catalent
• Communicates results both internally and externally through oral and written updates and formal reports as necessary.  Organize meetings and monitor all client interactions independently.  Participate in and lead cross-functional teams
• Performs secondary review of other colleagues' work for scientific accuracy and compliance. Creates and/or revises new department-wide and site-site procedures and company Standard Operating Procedures (SOPs)
• Individuals will proactively communicate strategy to clients and draft addendums to contracts and write and provide review of new proposals and change orders, as appropriate. Individuals will support the business aspects of their position by taking responsibility for the execution and billing communication for all work proposals under their supervision
• Hire, train, and supervise formulation group members as necessary.  Develop junior personnel for advancement within the team. Participate in Business Development and Marketing activities by generating scientific expert content, hosting new client visits or teleconferences, and attending conferences or client visits to generate new leads
• Responsible for maintaining a GMP laboratory environment and maintaining a safe, clean laboratory. Suggest and lead continuous improvement projects
• Other duties as assigned

The Candidate:

• 4-year degree (Bachelor's/B.S.) in a physical, chemical, biological, or pharmaceutical science required plus a minimum of six (6) years of drug product development experience. We will also consider candidates who have a Master of Science (M.S.) with five (5) years' experience, or PhD with three (3) years of experience in drug product development
• Preferred to have management experience; this person will immediately manage two people with the potential to manage a team of up to 6 in the future
• Preferred to have oral formulation development experience (Tablets, capsules, granulation, spray dried dispersion/amorphous dispersions)
• Strong preference for early phase development (preclinical, phase I-II with new APIs/small molecules), but will consider candidates with late stage or generics experience if they are a strong manager & communicator
• Experience in a client-facing role is a plus due to regular communication with internal/external stakeholders
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience
• Physical Requirements: On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 25 pounds. Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently

Pay:

• The anticipated salary range for this role in California is $132,000 to $140,000 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, 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.

Visit Catalent Careers to explore career opportunities.

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, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will 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. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.