Senior Analytical Scientist

Position Summary

The Analytical R&D Senior Scientist is responsible for performing analytical research and development work in the Analytical R&D Department. Analytical Senior Scientist work on method development, method transfer, method verification and method validation along with routine release and stability testing in support of clinical development and registration activities required for the regulatory submissions. The candidate will work closely with the product development and process transfer teams to provide analytical results in timely fashion and with proper data interpretation for drug product development through feasibility/development, tech transfer, registration, and validation phases of the assigned projects.

The Role

• Perform technical review of client's documents as required including but not limited to specification/validation reports/test methods/compliance reports etc. and identify and assess for compliance and to perform any gap analysis with respect to methods/instruments/procedures etc. for completing methods transfers from client's/or their third-party labs with no guidance from supervisors/senior team members.

• Analysis of finished products, in-process materials, raw materials, according to the assigned specifications, methods, and protocols according to cGLP and cGMP. Document, process, report the data as applicable to support the team in timely fashion.

• Demonstrate strong skills/expertise in handling LC (HPLC, UPLC), KF Titrators, Dissolutions, FT IR, UV-VIS, Malvern mastersizer, GC, ICP-MS/LC-MS/XRPD used in AR&D and ability to manage/handle with no guidance from supervisors/senior team members and ability to train/coach junior team members.

• Proficient in using Empower software- creating instrument/processing/report methods and performing online empower calculations for assay/impurities etc. Knowledge of Trackwise for managing deviations and investigations and ability to manage/handle with no guidance from supervisors/senior team members and ability to train/coach junior team members.

• Ability to perform method trouble shooting as required and propose any method improvement requirements during the method feasibility work of client supplied methods and/or during compendial method evaluation for assay, impurities, dissolution etc. with no guidance from supervisors/senior team members and ability to train/coach junior team members.

• Perform method transfers, Compendial verifications or full method validations (forced degradation and calculating mass balance/peak purity to prove stability indicating nature of the method) per applicable guidances (USP <1224>, <1225>, <1226> ICH Q2 etc.)/SOPs with no guidance from supervisors/senior team members and ability to train/coach junior team members.

• Perform stability testing on developmental/registration batches as per approved test methods/stability protocols and report/document per applicable specification/stability protocols. Escalate any OOS/OOT/atypical/trending results with supervisors or concerned team members.

• Responsible for handling and updating the Trackwise records related to OOS/OOT/atypical results/deviations/investigations according to the applicable SOP’s and addressing in timely fashion with least guidance from the supervisors/senior team members.

• Able to author / review SOP’s that fall within defined area of subject matter expertise with no guidance from senior team members/supervisors. Author & Review other technical documents not limited to specification, test methods, Certificate of analysis/Report of analysis and other technical documents as needed.

• Other duties as assigned.

The Candidate

• Work Experience – 7+ years of pharmaceutical industry experience with a P.h.D degree, and with at least 7 years of analytical testing/research experience using HPLC/GC/UV, etc.

• Work Experience – 8+ years of pharmaceutical industry experience with a M.S degree, and with at least 8 years of analytical testing/research experience using HPLC/GC/UV, etc.

• Work Experience – 10+ years of pharmaceutical industry experience with a B.S degree, and with at least 10 years of analytical testing/research experience using HPLC/GC/UV, etc.

• Understand analytical chemistry calculations such as concentrations (Area%, %w/w, ppm, µg/mL, etc.), molarity, Beer’s Law, reference standard purity on as is, anhydrous, or dry basis etc.

• Inspection of products, test results, and appropriately maintaining computerized documentation of required information.

• Safely perform testing required by position.

• Knowledge of and proper use of equipment.

• Safely handling chemicals and compounds.

• Regular cleaning of lab space as required.

• Coordination with other laboratory associates for maintaining safe environment

• Assisting with other personnel with lifting of liquid containers and all objects of greater than 50 lbs.

• Maintaining clean environment for laboratory operations.

• Use of and safe handling of glass canisters, chemicals, and other required equipment.

• Operating safely in a dynamic environment which includes mobile and fixed equipment and changing conditions while completing job tasks that range from simple to complex and/or multi-tasking.

Why You Should Join Catalent

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 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.

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