Position Summary:

Catalent Pharma Solutions in Kansas City, MO is hiring a Lead Scientist I who is primarily responsible for assay generation, design, development, and validation efforts for Biopharma product development under cGMP regulatory guidance for Large Molecules/Biologics product development and related stability studies. Also responsible for drafting, reviewing, and approving technical documents such as SOPs, methods, method forms, validation protocols and reports.

This is a full-time role position: Monday – Friday, daytime hours. Flexible with hours worked (7AM-3PM, 8AM-4PM, 9AM-5PM)

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 and compliance, 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: Capillary and Gel Electrophoresis (e.g., CE-SDS, SDS-PAGE, icIEF, IEF, western blot, etc.), Mass Spectrometry (LC and GC), Metals testing by ICP-MS, FTIR, CD, Intrinsic Fluorescence, DSC, Osmolality, Particulate measurements, Viscosity, Other technologies, or methodologies as required by management.
• Become a SME on 4-6 techniques mentioned above and perform sample testing activities.
• Provide leadership of assay generation, design, development, and validation efforts for Biopharma product development under cGMP regulations.
• Mentor, coach and train peers on cGMP compliance, methods and laboratory instruments and equipment. Lead CSV activities within the group.
• Follow cGMP requirements for legible, accurate and thorough documentation to meet regulatory compliance. Mentor junior colleagues in good documentation practices.
• Lead in drafting, review and approve technical documents such as SOPs, methods, method forms, validation protocols and reports with minimal guidance.
• Perform and co-ordinate peer review of Laboratory notebooks, logbooks, methods, method forms, reports and protocols
• Instruct colleague on policies, processes, and procedures for operating laboratory equipment in a safe and compliant manner. Becoming familiar with drug development milestones and their context
• All other duties as assigned;

The Candidate

• Required: Bachelor’s Degree in Life Sciences or Physical Science field with minimum of 11 years relevant experience in department specific techniques; OR Master’s degree in related life science or physical science field required with a minimum of 9 years relevant experience in department specific techniques; OR Doctorate degree in related life science or physical science field required with a minimum of 5 years relevant experience in department specific techniques.
• Previous experience working in GMP or cGMP environment required.
• Well organized with ability to multitask and execute multiple tasks within a given timeframe efficiently. Coaching skills are expected to train junior scientists
• In-depth knowledge in instrumentation, theory, data interpretation and applications in at least one technical area.
• Based on broad technical skills and drug development experience, anticipates, and identifies unmet customer needs.
• Be able to strategy and focus on personal time management and efficiency. Ability to work effectively under pressure to meet deadlines and exhibit critical thinking and offer solutions.
• Able to evaluate and assess impact of proposed changes to GMP documents and/or project scope

• 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 match and 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.

California Job Seekers can find our California Job Applicant Notice HERE.