Scientist 2, Analytical Development

Scientist 2, Analytical Development

Position Summary:

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Catalent Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP (Good Manufacturing Practices) manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best.

Catalent Pharma Solutions is hiring a Scientist 2, Analytical Development for our San Diego, CA team. The individual for this position will be responsible for the analytical development for solid oral and injectable drug candidates for human clinical studies, as well as preclinical drug products. An individual at the level of Scientist 2, Analytical Development will be expected to take responsibility for the completion of projects under minimal supervision. The individual will be expected to develop timelines and plan series of experiments as required by service agreements and then coordinate and possibly delegate responsibilities to meet client's expectations. The individual must have demonstrated proficiency in the development and qualification of analytical test methods, particularly stability indicating assays, dissolution methods, product specific cleaning methods, and water content methods for one or more drug product dosage form. The individual may be required to assist in the creation and/or revision of company Standard Operating Procedures (SOPs) and to participate in continuous improvement projects. The Scientist 2, Analytical Development will be increasingly sought for training and mentoring of other colleagues and assisting Quality Control/Assurance (QC/QA) in investigations as an Subject Matter Expert (SME). The individual may supervise lab assistants and/or 1 full-time employee. All duties will be performed in compliance with company standard operating procedures (SOPs) and GMP regulations, as appropriate.

This is a full-time salaried position on-site: Monday – Friday, day shift hours (1st shift).

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role:

• Perform and train others on a variety of analytical techniques including, but not necessarily limited to: analytical balances, pH meters, high performance liquid chromatography (HPLC/UPLC), UV/Vis spectroscopy, GC (gas chromatography), USP dissolution testing apparatus, moisture analysis by Karl Fischer, disintegration, Pion µdiss, PXRD (X-ray diffraction), DSC (Differential scanning calorimetry), FT-IR (infrared spectroscopy), TGA (thermogravimetric), and SEM (scanning electron microscopy), hardness, and friability testing
• Complex experimental design and execution will be performed independently with minimal supervisor assistance. Develop strategic experimental plans and timelines as well as cleaning verification methods
• Exercise technical discretion and critical thinking in the design, execution and interpretation of experiments independently with minimal supervisor assistance. 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
• Prepare update documents and technical reports for clients; Individuals will contribute to discussions with clients and peers on strategic matters
• 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
• Individuals should have a good general foundation of scientific principles, chemistry concepts, and be proficient in core analytical scientific techniques, GMPs, and technical writing
• May be invited to supervise laboratory assistant(s) and/or a full time employee; Collaboration with other departments to troubleshoot technical issues
• Other duties as assigned

The Candidate:

• Bachelor’s (BS) degree is required in a physical, chemical, biological, or pharmaceutical science with a minimum of three years of applicable industry experience. We will also accept a Master’s (MS) with two years’ experience, or a PhD with no formal industry experience
• Applicable experience entails: analytical development and method development with instrumentation including, but not necessarily limited to: analytical balances, pH meters, high performance liquid chromatography (HPLC/UPLC), UV/Vis spectroscopy, GC (gas chromatography), USP dissolution testing apparatus, moisture analysis by Karl Fischer, disintegration, Pion µdiss, PXRD (X-ray diffraction), DSC (Differential scanning calorimetry), FT-IR (infrared spectroscopy), TGA (thermogravimetric), and SEM (scanning electron microscopy), hardness, and friability testing
• Must have demonstrated proficiency in the development and qualification of analytical test methods for Active Pharmaceutical Ingredients (API), intermediates, and final drug products, particularly HPLC and UPLC stability-indicating assays, GC, dissolution methods, and water content methods. Demonstrated experience in physical characterization techniques such as TGA, DSC, PXRD, GVS, and SEM
• Candidate must also be highly detail-oriented and organized, able to work both independently and as a team player with a positive attitude. Must demonstrate excellent communication, critical thinking, and organizational skills
• 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 San Diego, CA is $90,000 to $115,000 annually. The final salary offered to a successful candidate may, 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 DisabilityAccommodations@catalent.com. 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 spam@catalent.com for us to investigate with local authorities.

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