Pharmaceutical Development Senior Scientist I

About Site

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.

Position Summary

We have an opportunity for a Pharmaceutical Development Senior Scientist I to join our team. In this role, you will lead formulation design and development of oral solid dosage forms. You will design and execute experiments, oversee clinical trial manufacturing, and ensure compliance with regulatory requirements and good manufacturing practices. You will also author and approve technical documents and play a key role in customer interactions and project outcomes.

Shift: Monday to Friday 8am-5pm Location: Kansas City, MO 100% Onsite

The Role

Develop and execute laboratory work plans and schedules for self and junior team members, using customer milestones and site performance standards

Independently author and approve technical documents such as protocols, technical reports, batch records, test methods, and operating procedures

Review technical documents for accuracy, thoroughness, and regulatory compliance

Train, coach, and mentor others on technical, personal development, or business issues

Supervise technical staff, including work assignments and performance management

Serve as project technical lead on multiple projects, ensuring project outcomes and managing customer interactions

Apply knowledge of high-shear granulation, fluid-bed technology, roller compaction, compression, encapsulation, and formulation development

Drive improvement projects at the department level and identify opportunities for improvement

Support development of business strategies across business units

Use comprehensive knowledge to lead complex projects within the pharmaceutics department

Design experiments and projects that contribute to the overall direction of the department

Perform all other duties as assigned

The Candidate

Minimum Requirements

Bachelor's degree in a related life science or physical science field with 16+ years of related work experience preferred

Knowledge of techniques in design of experiments

Ability to maintain current Good Manufacturing Practices and Good Documentation Practices in accordance with regulatory guidance and site procedures

Advanced project management skills for multiple concurrent projects of moderate complexity

Experience in most aspects of drug development and lifecycle support, with ability to develop strategies to meet regulatory milestones

Broad technical acumen in multiple techniques and understanding of their application in pharmaceutical services

Ability to provide reliable interpretations of regulatory guidance for customers

Capable of rapid learning of unfamiliar principles or techniques with minimal training

Strong organizational skills with ability to manage multiple activities simultaneously

Excellent written and verbal communication skills with internal and external customers

Ability to communicate moderately complex technical information to non-technical audiences

Leadership development and supervisory skills expected

Ability to recommend and assist in implementation of new technologies and understand their impact on offerings

High personal credibility with peers and subordinates

Strong motivational skills and team development experience

Lead by example according to company values and culture

Ability to assess training needs and create development plans for direct reports

Ability to anticipate and identify unmet customer needs based on technical skills and drug development experience

Ability to interpret and manage a variety of instructions across multiple work groups

Understanding of regulatory Chemistry, Manufacturing, and Controls (CMC) filing package and required drug product documentation

Ability to work effectively under pressure to meet deadlines

May publish or present externally

Stand, walk, sit, use hands to manipulate, and reach with hands and arms for up to 6 hours per day

Frequent sitting, standing, walking, reading of written documents, and use of computer monitor screen

Able to work with respirator (P100, PAPR, etc.)

Occasional lifting and/or moving up to 50 pounds

Preferred Skills & Background

Hands-on experience in oral solid dosage form development and manufacturing preferred

Master’s degree in a related life science or physical science field with 14+ years of related work experience preferred

Doctorate degree in a related life science or physical science field with 10+ years of related work experience preferred

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 within an organization dedicated to preserving and bettering lives

Competitive paid time off plus 8 paid holidays

Community engagement and green initiatives

Medical, dental, and vision 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.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

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.

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