Scientist 2, Analytical Development Jobs

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 HPLC stability indicating assays, dissolution methods, product specific cleaning methods, and water content methods for one or more drug product dosage form. The individual should also have proficiency in physical characterization techniques such as TGA, DSC, PXRD, GVS, and SEM. The individual may be required to assist in the creation and/or revision of company 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 QC/QA in investigations as an SME. The individual may supervise lab assistants and/or 1 FTE. All duties will be performed in compliance with company standard operating procedures (SOPs) and GMP regulations, as appropriate.

This is a full-time position: Monday – Friday, days.

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

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 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 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 (other duties as assigned):

• Individuals should have a good general foundation of scientific principles, chemistry concepts, and be proficient in core analytical scientific techniques, GMPs, and technical writing.
• Develop strategic experimental plans and timelines as well as cleaning verification methods
• Complex experimental design and execution will be performed independently with minimal supervisor assistance.
• Prepare update documents and technical reports for clients; Individuals will contribute to discussions with clients and peers on strategic matters.
• May be invited to supervise laboratory assistant(s) and/or a full time employee; Collaboration with other departments to troubleshoot technical issues.
• 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, USP dissolution testing apparatus, moisture analysis by Karl Fischer, disintegration, Pion µdiss, DSC, TGA, PSD, PXRD, SEM, hardness, and friability testing.
• 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
• 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.

The Candidate (requirements)

• Must demonstrate excellent communication, critical thinking, and organizational skills.
• Demonstrated proficiency in the development and qualification of analytical test methods for API, intermediates, and final drug products, particularly HPLC and UPLC stability-indicating assays, GC, dissolution methods, and water content methods.
• 4-year degree in a physical, chemical, biological, or pharmaceutical science required
• Candidate must also be highly detail-oriented and organized, able to work both independently and as a team player with a positive attitude.
• MS with 2+ years of experience in analytical development
• BS with 3+ years of experience in analytical development
• Physical requirements: must be able to lift up to 25lbs, walk/sit/stand on regular basis, and regular use of computers
• PhD with 0+ years of experience in analytical development
• Demonstrated experience in physical characterization techniques such as TGA, DSC, PXRD, GVS, and SEM.

Pay:

The anticipated salary range for this role in San Diego, CA is $90,000 to $110,160 annually. The final salary offered to a successful candidate may vary or fall outside of the range provided, 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:

• Several Employee Resource Groups focusing on D&I
• Community engagement and green initiatives
• On-site fitness center and wellness programs
• 19 days of PTO + 10 paid holidays
• Environmentally friendly with on-site practices as well as regularly participating in Beach Clean-up activities
• Positive working environment focusing on continually improving processes to remain innovative
• Defined career path and annual performance review and feedback process
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Generous 401K match and Paid Time Off accrual
• 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
• Dynamic, fast-paced work environment
• Tuition Reimbursement – Let us help you finish your degree or earn a new one!
• Diverse, inclusive culture
• Competitive salary with bonus potential
• Tuition Reimbursement – Let us help you finish your degree or earn a new one!
• GymPass program to promote overall physical wellness
• Medical, dental and vision benefits effective day one of employment

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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 [email protected]. 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 [email protected] for us to investigate with local authorities.

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