Catalent Pharma Solutions Scientist I (Analytical Development - HPLC) in San Diego, California

Job Description

Catalent Pharma San Diego is hiring for a Scientist I in our Analytical Development department who will be expected to either lead projects as an individual contributor or to build and lead a team focused on the development of analytical methods for small molecule and peptide drug products. The main focus will be HPLC/UPLC-UV stability-indicating methods using various separation chemistries including but not limited to reversed phase, ion-exchange, and chiral, using Empower chromatography software and Waters hardware. However alternate detection methods such as ELSD may be employed. In addition, the Scientist I may be responsible overseeing development of assay, dissolution, water content, and physical characterization methods for oral and injectable drug products. The individual will assist in the researching and introduction of new analytical technology to characterize drug products and will be the primary point of customer contact for analytical strategy, compliance, and troubleshooting. There is an expectation of direct hands-on laboratory work and/or supervision of multiple direct reports and mentoring/training of other colleagues as needed.

The Role (daily responsibilities)

  • Develop stability-indicating HPLC or UPLC methods for peptide and small molecule API and drug products from scratch.

  • Develop and qualify cleaning verification methods (surfactant screening, UPLC verification)

  • 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, DSC, TGA, PSD, PXRD, hardness, and friability testing.

  • Troubleshoot existing HPLC or UPLC methods internalized to Catalent from other vendors.

  • Perform API and drug product HPLC and UPLC method qualification studies per ICH guidelines to determine if methods are suitable for transfer to Quality Control.

  • Communicate results both internally and externally through oral and written updates and formal technical reports as necessary. Organize meetings and monitor all client interactions independently. Supervisor will be notified if their assistance is needed.

  • Assist in the creation and/or revision of new department-wide and site-site procedures and company SOPs.

  • Collaboration with Quality Assurance and Quality Control on analytical method validation and compliance issues

  • Individuals will stay abreast of current scientific technologies to maintain the state of the art nature of Catalent’s services.

  • Individuals will proactively communicate strategy to clients and provide initial review of new proposals and addendums to contracts 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 1-4 analytical group members as necessary

The Candidate (requirements)

  • BS degree in a physical or biological science (Chemistry preferred) with 6 to 10 years of experience REQUIRED in analytical development. OR MS with 5 to 8 years of experience required in analytical development. OR PhD with 1 to 3 years of experience required in analytical development.

  • Small molecule and drug product method development experience is REQUIRED to be considered. HPLC/UPLC method development experience and early phase knowledge MUST HAVE.

  • Previous supervisory experience preferred as this role potentially will oversee a team of 1-3 junior level personnel. Those candidates with previous team leadership and supervisory experience will be given first consideration.

  • Strong communication skills including written and oral/presentation ability.

Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

Position Benefits

  • Potential for career growth within an expanding team

  • Defined career path and annual performance review and feedback process

  • Medical, Dental, Vision and 401k are all offered from Day One of employment

  • Generous paid time off (PTO) and holidays

About Catalent San Diego

Catalent San Diego, Inc. (Formerly Pharmatek Laboratories, Inc.) is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. Catalent San Diego focuses on bringing client drug compounds from discovery to the clinic with services that include analytical development, preformulation testing, formulation development, GMP manufacturing and stability storage and testing. 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. We provide a generous benefits package, on-site gym and fitness programs, team sports, activities and competitive compensation.

About Catalent Pharma Solutions

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals 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, for the benefit of patients globally.

Catalent. More products. Better treatments. Reliably supplied.™

Visit www.catalent.com/careers to explore career opportunities, or contact us at +1 877 503 9493.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.

Catalent = Catalyst + Talent

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

Grow with us. Be challenged. Make a personal impact.

Catalent is the perfect place to grow your career if…

  • You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).

  • You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!

  • You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.

  • You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.

  • You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!

  • See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.