Principal Scientist, MS&T

Company: Disability Solutions
Location: Bloomington
Posted on: November 15, 2024

Job Description:

Principal Scientist MS&T 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.--Process Engineering focuses on developing processes to minimize risks to the product. The role works with industry experts/consultants to create design specifications, P&ID drawings, general arrangement drawings, user requirements, functional specifications, and automation control strategies. Provides technical solutions to complex problems by relying upon their experience and/or seeking recommendations from industry experts.The Manufacturing Sciences and Technology (MS&T) department's primary function is to serve as an agile technical team to support process & technology transfer (e.g., mAbs, fusion proteins, new modalities, etc.), raw materials and consumables, technical writing, and drug substance lifecycle management.--The MS&T organization supports the Drug Substance area of the Bloomington facility as well as the Catalent Biologic's network through client-facing support, on-the-floor or on-call technical coverage, and continuous improvement.The Principal Scientist will be responsible for the technical transfer of processes from Process Development or our clients.-- It will also involve drafting and review of documentation, compilation, and assessment of process data, and providing technical input for deviation investigations, change controls, and CAPAs. This role will provide on-call and on-the-floor technical support to manufacturing. ----This position will be client facing and should possess the ability to work collaboratively with clients and internal cross-functional stakeholders to move projects forward.This role works days; Monday - Friday Catalent Pharma Solutions in Bloomington, Indiana is a state-of-the-art, GMP manufacturing facility, providing one million sq/ft of drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients live better healthier lives.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:

• Perform as a subject matter expert (SME) for multiple Drug Substance operations (e.g., Upstream Processes (seed train, production bioreactor processes), Downstream Processes (chromatography, tangential flow filtration, etc.)), Formulations)
• Utilize Process Development and client provided process data to review proposed GMP scale process descriptions.-- Create process flow diagrams from process descriptions
• Lead efforts associated with the evaluation, alignment, and recommendation of equipment and process improvements--
• Review daily processing data from GMP manufacturing to monitor process performance and anticipate performance in subsequent steps; work closely with manufacturing to author appropriate batch documentation and provide technical and strategic oversight associated with GMP manufacturing
• Evaluate existing processes and implement process or equipment improvements to advance efficiency, consistency, and competitiveness within the market
• Act as the lead for technical support of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification
• Responsible for motivating, coaching, and developing coworkers as a subject matter expert; act as a mentor to lower-level team members and Co-ops/interns
• Other duties as assignedThe Candidate:
  • Bachelor's degree in Science and 7+ years of pharmaceutical industry experience, required
  • Master's degree in Science and 5+ years of pharmaceutical industry experience, preferred
  • 5 years GMP or regulated industry experience, required
  • Must be able to read and understand English-written job instructions and safety requirements.Why you should join Catalent:
    • Competitive medical benefits and 401K
    • 152 hours of PTO + 8 Paid Holidays
    • ---Dynamic, fast-paced work environment
    • Opportunity to work on Continuous Improvement ProcessesCatalent 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.--personal initiative. dynamic pace. meaningful work.Visit 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 . 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 .

Keywords: Disability Solutions, Louisville , Principal Scientist, MS&T, Other , Bloomington, Kentucky