Pharmaceutical Development Lead Scientist II

Catalent, Inc.; Kansas City (MO); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

Paid time off and holidays

Job summary

Catalent, Inc. in Kansas City seeks a Pharmaceutical Development Lead Scientist II to lead formulation and process design for oral solid dosage forms. You will participate in clinical trial manufacturing, ensuring GMP compliance and adherence to SOPs.

Strong communication and organizational skills are essential. Shift: Mon–Fri 8am–5pm; 100% onsite at Kansas City, MO. Responsibilities include leading junior team members, reviewing documents for regulatory acceptance, and guiding multiple projects

Qualifications

• Bachelor's degree in a related life science or physical science field with 13+ years of related work experience.
• Internal subject matter expert in at least one technical area with strong data interpretation, instrumentation, theory, regulatory guidance, and CMC filing elements.
• Provide accurate data and integrate information from multiple disciplines to support project decisions.
• Prioritize work and propose alternatives to achieve effective technical solutions with efficient resource use.
• Communicate technical information effectively to non-technical audiences and share expertise via publications or presentations as appropriate.
• Demonstrate leadership and supervisory capabilities, including assessing new technologies and staff development.

Responsibilities

• Develop and execute laboratory work plans and schedules for self and junior team members.
• Review technical documents for accuracy and regulatory compliance.
• Train, coach, mentor, and supervise technical staff, including performance management.
• Serve as the project technical lead on one or more projects with customer interaction.
• Lead intermediate-complexity projects within the department.
• Design experiments, processes, and formulations to meet objectives.
• Lead efficiency-improvement projects and identify project opportunities.
• Participate in client, team, and ad hoc meetings with minimal supervision.
• Perform all other duties as assigned.

Skills

Data interpretation

Regulatory guidance

Leadership

Cross-functional collaboration

Effective communication

CMC filing elements

Education

Bachelor's degree in related life/physical science

Master's degree in related life/physical science

Doctorate in related life/physical science

Job description

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 Lead Scientist II to join our team. In this role, you will serve as the technical lead for formulation and process design of oral solid dosage forms. You will participate in clinical trial manufacturing and ensure compliance with regulatory requirements, good manufacturing practices, and standard operating procedures. This position requires strong communication skills, the ability to work under pressure, and excellent organizational capabilities.

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, aligned with customer milestones and site performance standards.
• Review technical documents for accuracy, thoroughness, and regulatory compliance.
• Train, coach, mentor, and supervise technical staff, including work assignments and performance management.
• Serve as the project technical lead on one or more projects, with responsibility for project outcomes and customer interaction.
• Apply comprehensive knowledge to lead intermediate-complexity projects within the department.
• Design experiments, processes, and formulations that contribute to group objectives.
• Develop and execute efficiency improvement projects and identify or recommend project-specific business opportunities.
• Participate in client, team, and ad hoc meetings with no supervision.
• Perform all other duties as assigned.

Minimum Requirements

• Bachelor's degree in a related life science or physical science field with 13+ years of related work experience required.
• Serve as an internal subject matter expert in at least one technical area, with strong understanding of data interpretation, applications, instrumentation, theory, regulatory guidance, CMC filing elements, and supporting documentation.
• Provide accurate data and combine or interpret information from multiple disciplines to support project decisions and technical recommendations.
• Prioritize work and recommend alternatives or contingencies to achieve effective technical solutions with efficient resource utilization.
• Communicate technical information effectively to non-technical audiences, with ability to share expertise through external publications or presentations as appropriate.
• Demonstrate leadership and supervisory capabilities, including assessing new technologies, evaluating training needs, and developing plans for subordinates.

Preferred Skills & Background

• Master's degree in a related life science or physical science field with 11+ years of related work experience preferred.
• Doctorate degree in a related life science or physical science field with 7+ 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.

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 [e-mail]. 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.

Catalent is an Equal Opportunity Employer, including disability and veterans.