Senior Scientist Iii - Lead Investigator

Senior Scientist III - Lead Investigator
Position Summary:
Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.
Catalent Pharma Solutions is hiring a Senior Scientist III - Lead Investigator. This position requires a variety of skills necessary for biotech company operations. The Senior Scientist III - Lead Investigator will support the QC laboratory OOS investigation and deviation processes. Root cause analysis tools, technical writing, thorough communication and management of records are the primary focus for this role.
This is a full-time, salaried position: Monday - Friday, 8:00am - 5:00pm
Catalent Biologics in Madison is based in our new, state of the art, 100,000 square foot facility, with expanded mammalian cell line engineering and biomanufacturing capabilities utilizing single-use systems, Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer's and more.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
The Role

• Independently executes and properly documents cGMP Quality Control testing
• Authors technical documents such as SOPs and reports
• Independently operates basic, moderately complex, and complex cGMP Quality Control equipment
• Leads continuous process improvement initiatives.
• initiates and leads investigations or deviations in Trackwise
• Performs general lab housekeeping in adherence to 5S standards.
• Performs self-review of analytical data for accuracy and consistency with SOP.
• Actively participates in team meetings and/or training sessions.
• Other duties as assigned.

The Candidate

• PhD Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 6 years of industry experience
• Master's Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 8 years of industry experience.
• Bachelor's Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 10 years of industry experience
• Associate Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 14 years of industry experience
• Excellent written and oral communication skills are essential
• Investigative experience a must.
• cGMP, Good Documentation Practices (GDP) or Good Laboratory Practices (GLP) knowledge a must.
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.

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.
• Cross-functional exposure to other areas within the organization.
• Competitive salary with quarterly bonus potential
• 152 hours of paid time off annually + 8 paid holidays.
• Medical, dental, vision and 401K benefits effective day one of employment.
• Tuition Reimbursement.

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.
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 spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.