Scientist II, QC

Scientist II QC

Position Summary:

• Work Schedule: Monday - Friday 8:00am to 5:00pm
• 100% on-site

The Morrisville (MSV) facility is Catalents center of excellence for nasal product development and manufacturing providing endtoend services from early formulation through clinical and commercial production. The site offers comprehensive nasal development capabilities including analytical support device selection spray characterization and both clinical and commercial scale for unitdose bidose and multidose nasal products. The Morrisville site also provides development services for dry powder (DPI) and liquid pulmonary products including formulation development and optimization methodservicesand analytical testing.

The Scientist II Quality Control - Nasal Drug Products is an advanced independent contributor responsible for execution oversight and technical problem-solving related to cGMP QC testing of nasal drug products including raw materials in-process materials stability samples and finished drug products.

The Role:

• Independently execute and lead routine to moderately complex cGMP QC testing for nasal drug products in accordance with approved test methods SOPs and regulatory expectations
• Perform and interpret analytical testing relevant to inhalation and nasal dosage forms which may include physicochemical testing (e.g. pH osmolality viscosity) compendial testing assay/impurity methods and other product-specific analyses (e.g. spray testing) as applicable
• Serve as a technical resource for inhalation and nasal product testing including troubleshooting assay performance investigating atypical results and proposing scientifically sound corrective actions
• Lead or support OOS OOT deviation and investigation activities including data evaluation root cause analysis contributions and technical documentation
• Author and support-controlled QC documents including test methods validation/transfer documentation protocols reports and investigation technical sections
• Other duties as assigned

The Candidate:

• Bachelors Degree in a scientific discipline with minimum of 6 years experience OR Masters Degree in a scientific discipline with minimum 4 years experience in a GMP laboratory environment is required
• Demonstrated experience with nasal drug products inhalation products or combination products is strongly preferred
• Strong working knowledge of GMP GDP data integrity principles and regulatory expectations for QC laboratories is required
• Ability to evaluate trends interpret complex datasets and support scientifically defensible decisions is required
• Strong technical writing skills for QC documentation investigations methods and validation deliverables is required

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Diverse inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of PTO 8 paid holidays
• Generous 401K match
• Medical dental and vision benefits
• Tuition Reimbursement- Let us help you finish your degree or start a new degree!

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.

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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.

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Required Experience:

IC