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Senior Analytical Stability Expert

2 months ago

Morrisville, United States Catalent Full time

Position Overview:

Catalent Pharma Solutions is seeking a Lead Stability Specialist to join our Analytical Stability Group. This role is pivotal in facilitating pharmaceutical evaluations across various dosage forms, working closely with clients and in partnership with other Catalent facilities. The testing conducted is essential for ensuring the stability of both pre-commercial and commercial pharmaceutical products.

Employment Type: Full-time, Monday – Friday, 8:00 AM – 5:00 PM.

Catalent is a rapidly expanding, publicly traded organization and a prominent collaborator in the pharmaceutical sector, dedicated to the development and manufacturing of innovative treatments for patients globally. Your skills, insights, and enthusiasm are vital to our mission: enhancing the quality of life for individuals.

Our Research Triangle Park facility serves as Catalent's Center of Excellence for Analytical Services and is also the hub for our Inhalation franchise, encompassing product development, clinical trials, and commercial manufacturing for pMDI, DPI, and Nasal Sprays.

Commitment to Quality:

Catalent is devoted to a Patient First culture, emphasizing excellence in quality and compliance, ensuring the safety of every patient, consumer, and employee.

Key Responsibilities:

  • Design and implement laboratory work plans for yourself and junior team members, aligning with customer milestones and site standards.
  • Create and evaluate technical documents, including protocols, testing methods, reports, certificates of analysis, and operational procedures as necessary.
  • Provide training, coaching, and mentorship on technical, personal development, or business matters.
  • Assess technical documents for precision, thoroughness, and adherence to regulatory standards.
  • Act as Project Director for one or more projects, overseeing project outcomes and client interactions.
  • Initiate and execute projects aimed at enhancing efficiency.
  • Perform additional duties as assigned.

Candidate Profile:

  • A Bachelor's degree is mandatory; a Master's degree or PhD is preferred.
  • A minimum of 9 years of experience is required with a Bachelor's degree, 6 years with a Master's degree, and 2 years with a PhD.
  • Strong ability to absorb and retain technical information is essential.
  • Expertise in data interpretation, application, instrumentation, and theory in at least one technique is required.
  • Capability to synthesize and analyze data from various disciplines is necessary.
  • Proactive in identifying and addressing unmet client needs.
  • Familiarity with regulatory CMC filing packages and analytical documentation is required.
  • The role may require regular sitting, standing, walking, and occasional lifting of 0-15 pounds.

Why Choose Catalent:

  • Clear career progression and annual performance evaluations.
  • A diverse and inclusive workplace culture.
  • A supportive environment focused on continuous process improvement and innovation.
  • Opportunities for career advancement within a team dedicated to enhancing lives.
  • Generous paid time off and holiday benefits.
  • Numerous Employee Resource Groups promoting diversity and inclusion.
  • A dynamic and fast-paced work atmosphere.
  • Engagement in community service and sustainability initiatives.
  • Competitive 401K matching.
  • Company contributions to charitable organizations.
  • Comprehensive medical, dental, and vision benefits starting on the first day of employment.
  • Tuition reimbursement programs to support your educational goals.
  • Wellness programs to promote overall health.
  • Access to exclusive discounts from a wide range of merchants.

Catalent offers fulfilling career opportunities: Join a global leader in drug development and delivery, contributing to the advancement of over 7,000 life-saving and life-enhancing products for patients worldwide. Catalent is an exciting and growing international organization where employees collaborate with pharmaceutical, biopharmaceutical, and consumer health companies of all sizes to progress new medicines from early development through clinical trials to market. Catalent produces over 70 billion doses annually, each one relied upon by individuals in need. Join us in making a significant impact.

Catalent prioritizes the health and safety of its employees, visitors, and the customers and patients we serve. In response to the global pandemic, we have adapted many of our recruitment and onboarding processes to ensure everyone's safety. The Human Resources team will communicate all necessary safety protocols throughout each stage of the process.

Catalent is an Equal Opportunity Employer, including individuals with disabilities and veterans.

If you require reasonable accommodation during the application or hiring process due to a disability, please submit your request through the appropriate channels. This option is reserved for individuals needing accommodation due to a disability.

Important Security Notice to Job Seekers:

Catalent NEVER requests candidates to provide payment, bank details, identification copies, social security numbers, or other sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive such a request, DO NOT respond— it is fraudulent. Please report such requests for investigation.