Scientist II, Biologics II

Company: Catalent
Location: Kansas City
Posted on: November 25, 2022

Job Description:

Position Summary:

Catalent Pharma Solutions in Kansas City, MO is hiring a Scientist II, Biologics II who is primarily responsible for method evaluation, optimization, transfer and validation activities under cGMP regulatory guidance for Large Molecules/Biologics product development and related stability studies. Also responsible for drafting technical documents such as methods, method forms, validation protocols and reports. .

This is a full-time role position: Monday - Friday, days.

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's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.

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

• In support of Large Molecules/Biologics Therapeutics, will execute laboratory testing using the following techniques as required: HPLC/UPLC techniques/methods (e.g., SEC, IEX, RP-HPLC, HIC, peptide map, glycan analysis, etc.), Karl Fischer, Compendial assays, (i.e., appearance. pH, etc.)
• UV-Vis, Aggregation techniques such as MFI, AUC, SEC-MALS
• Successfully trains on 2-4 methods and/or techniques mentioned above and perform adhoc sample testing activities and participate with minimum guidance in method development, evaluation, optimization, transfer, and validation activities under cGMP as required
• Applies complex scientific and laboratory concepts and theories related to specific testing in the group
• Train and coach peers on methods and laboratory instruments and equipment
• Follow cGMP requirements for legible, accurate and thorough documentation to meet regulatory compliance.
• Drafts and review technical documents such as methods, method forms, validation protocols and technical reports with minimal guidance.
• All other duties as assigned;
  
  The Candidate
  
  • Degree in life sciences such as chemistry, biochemistry, biology or closely related physical science.
  • Required Bachelors Degree: 8+ years of relevant experience; OR Masters Degree: 6 years of relevant experience; OR Doctorate Degree: 2 years of relevant experience
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Capable of rapid learning of unfamiliar principles or techniques with minimum training.
  • Able to prioritize and suggest alternatives or contingencies to achieve the correct technical solutions with most efficient resource utilization.
  • Ability to identify aberrant/out of spec data and limited interpretation of data expected
  • 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
    • 19 days of PTO + 8 paid holidays
    • Several Employee Resource Groups focusing on D&I
    • Dynamic, fast-paced work environment
    • Employee Stock Purchase Program
    • Positive working environment focusing on continually improving processes to remain innovative
    • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
    • Competitive salary with quarterly bonus potential
    • Community engagement and green initiatives
    • Generous 401K matchand Paid Time Off accrual
    • Medical, dental and vision benefits effective day one of employment
    • Tuition Reimbursement
    • GymPass 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 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.

Keywords: Catalent, Kansas City , Scientist II, Biologics II, Other , Kansas City, Kansas