Senior Scientist, Analytical Development

Senior Scientist 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 in San Diego CA is hiring a Senior Scientist in Analytical Development. An individual at the level of Senior Scientist Analytical Development will be expected to either lead projects independently or build a team focused on the development of analytical methods for small molecule peptide drug products and amorphous intermediates. This individual may be required to have direct reports depending on growth and ability. The focus of this role will be HPLC/UPLC-UV stability-indicating methods using various separation chemistries including but not limited to reversed phase ion-exchange and addition the individual may be responsible for overseeing development of assay dissolution water content and physical characterization methods for oral and injectable drug products. The Senior Scientist Analytical Development will be required to assist QC/QA in investigations as an SME. All duties will be performed in compliance with company standard operating procedures (SOPs) and GMP (Good Manufacturing Practices) regulations as appropriate.

This is a full-time salaried position Monday-Friday on 1st shift (day shift) with flexibility.

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

The Role:

• Develop stability-indicating methods for peptide and small molecule API (Active Pharmaceutical Ingredient) amorphous intermediates and drug products from scratch. Develop cleaning verification methods.
• 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 diss PXRD (X-ray diffraction) DSC (Differential scanning calorimetry) FT-IR (infrared spectroscopy) TGA (thermogravimetric) and SEM (scanning electron microscopy) hardness and friability testing.
• Troubleshoot and optimize analytical methods for characterization of drug products and intermediates. Clear and accurate record keeping in laboratory notebooks and secondary review of other colleagues work for scientific accuracy and compliance. Responsible for transfer of analytical methods to other sites as required. Collaboration with other departments to troubleshoot technical issues.
• Communicate results both internally and externally through oral and written updates and formal 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-wide procedures and company 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 Catalents services. 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 analytical group members as necessary. Develop junior personnel for advancement within the team. Suggest and lead continuous improvement projects.
• Other duties as assigned.

The Candidate:

• A Bachelors (BS) degree is required in a physical chemical biological or pharmaceutical science with a minimum of six years of experience in analytical development for small molecules/peptides. We will also accept a Masters (MS) with five years experience or a PhD with three years of 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 reverse-phase ion and chiral) UV/Vis spectroscopy GC (gas chromatography) USP dissolution testing apparatus moisture analysis by Karl Fischer disintegration Pion diss PXRD (X-ray diffraction) DSC (Differential scanning calorimetry) FT-IR (infrared spectroscopy) TGA (thermogravimetric) and SEM (scanning electron microscopy) hardness and friability testing.
• 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 starting salary range for this role in San Diego CA is $120000 to $130000 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 7000 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.