Pharmaceutical Development Senior Scientist I

Catalent Pharma Solutions • Kansas City, MO

1d • Onsite

About The Position

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.

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

Nice To Haves

• 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

Responsibilities

• 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

Benefits

• Competitive paid time off plus 8 paid holidays
• Medical, dental, and vision benefits effective day one of employment
• Tuition reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Senior