Scientist I

Catalent

San Diego,CA  

2019-10-17 2019-11-16
pharma

At Catalent, we recognize talent is our most important asset. Propelled by the passion to excel, we are committed to attracting, developing, and retaining talented and dedicated professionals who can help us deliver on our promise of more products, better treatments, reliably supplied.

From helping our customers produce world-class pharmaceutical products to identifying future technologies that will improve drug delivery, we achieve our amazing breakthroughs and innovations because of our talent!



Job Description

Position Overview:



Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here











Job Title: Analytical Development Scientist







City: San Diego



State: California









+ Lead projects as an individual contributor or to build and lead a team focused on the development of analytical methods for small molecule and/or peptide drug products.



+ Use HPLC/UPLC-UV stability-indicating methods using various separation chemistries including but not limited to reversed phase, ion-exchange, size exclusion, and chiral, using Empower chromatography software and Waters hardware; alternate detection methods including ELSD.



+ Oversee development of assay, dissolution, water content, and physical characterization methods for oral and injectable drug products.



+ Assist in the research and introduction of new analytical technology to characterize drug products and act as primary point of customer contact for analytical strategy, compliance, and troubleshooting.



+ Perform direct hands-on laboratory work and/or supervision of multiple direct reports and mentoring/training of other colleagues as needed.







+ Perform and train others on a variety of analytical techniques including, but not 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, particle size by Malvern Mastersizer or zetasizer, disintegration, DSC, TGA, PXRD, SEM, hardness, and friability testing.



+ Troubleshoot existing HPLC or UPLC methods internalized to company 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.



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



+ Communicate strategy to clients and provide initial review of new proposals and addendums to contracts as appropriate.



+ Support business aspects by taking responsibility for the execution and billing communication for all work proposals under supervision.







+ Work on a cross-functional project team with formulation scientists, process engineers, and project managers.



+ Provide technical and professional training to analytical development chemists.







+ Develop drug product testing methods (HPLC, UPLC, discriminating dissolution, water content, residual solvents, particle size by light diffraction per USP <429>, SEC) for oral and injectable dosage forms.



+ Develop and qualify cleaning verification methods (surfactant screening, chromatographic verification)



+ Develop peptide and protein quality and physical stability methods (HPLC or SEC)



+ Apply GMP requirements and IND-enabling analytical method development strategies for preclinical through Phase 2 programs



+ Use Empower data collection software.



+ Manage entry level chemists, including conducting performance reviews.









EDUCATION AND EXPERIENCE REQUIREMENT: Requires a Master’s degree in Chemistry or Pharmaceutical Sciences and 3 years of experience in job offered or 3 years of experience in the Related Occupation







RELATED OCCUPATION:







Sr. Associate Scientist or any other job title performing the following job duties:









+ Leading projects as an individual contributor or to build and lead a team focused on the development of analytical methods for small molecule and/or peptide drug products.



+ Using HPLC/UPLC-UV stability-indicating methods using various separation chemistries including but not limited to reversed phase, ion-exchange, size exclusion, and chiral, using Empower chromatography software and Waters hardware; alternate detection methods including ELSD.



+ Overseeing development of assay, dissolution, and physical characterization methods for injectable drug products.



+ Assisting in the research and introduction of new analytical technology to characterize drug products and act as primary point of customer contact for analytical strategy, compliance, and troubleshooting.



+ Performing direct hands-on laboratory work and/or supervision of multiple direct reports and mentoring/training of other colleagues as needed.







+ Performing and training others on a variety of analytical techniques including, but not limited to: analytical balances, pH meters, high performance liquid chromatography (HPLC/UPLC), UV/Vis spectroscopy, GC, USP dissolution testing apparatus, moisture analysis, and particle size by Malvern Mastersizer or zetasizer.



+ Troubleshooting existing HPLC or UPLC methods internalized to company from other vendors.



+ Performing qualification studies per ICH guidelines to determine if methods are suitable for transfer to Quality Control.



+ Communicating results both internally and externally through oral and written updates and formal technical reports as necessary. Organizing meetings and monitoring all client interactions independently.



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



+ Communicating strategy to clients and provide initial review of new proposals/additions to project scope for analytical specific tasks/ideas.



+ Supporting business aspects by taking responsibility for the execution and billing communication for all work proposals under supervision.







+ Working on a cross-functional project team with formulation scientists, process engineers, and project managers.



+ Providing technical and professional training to analytical development chemists.







+ Developing drug product testing methods (HPLC, discriminating dissolution, water content, particle size by light diffraction per USP <429>, SEC) for injectable dosage forms.



+ Developing peptide and protein quality and physical stability methods (HPLC or SEC)



+ Applying GMP requirements and IND-enabling analytical method development strategies for preclinical through Phase 2 programs



+ Using Empower data collection software.



+ Demonstrating ability to guide and train entry level chemists, including providing goals and feedback on performance.









JOB TIME: Full Time







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 www.catalent.com/careers to explore career opportunities.











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, 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.





Paragon Gene Therapy, a unit of Catalent Biologics, in Baltimore, Maryland is a leading viral vector development and manufacturing partner in the rapidly expanding gene therapy market. To browse career opportunities in Maryland, click here.





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!







personal initiative. dynamic pace. meaningful work.







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.
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