Pharmaceutical Development Lead Scientist I

Catalent Pharma Solutions•Kansas City, MO

1d•Onsite

About The Position

We have an opportunity for a Pharmaceutical Development Lead Scientist I to join our team. In this role, you will serve as the technical lead for formulation design and development of oral solid dosage forms. You will design and execute experiments and processes for pharmaceutical formulations and lead clinical trial manufacturing activities. This position ensures compliance with regulatory requirements, good manufacturing practices and standard operating procedures.

Requirements

Bachelor's degree in a related life science or physical science field with 11+ years of related work experience preferred
Expert in data interpretation, applications, instrumentation and theory in at least one area of expertise
Ability to provide accurate data within regulatory guidance
Experience evaluating and assessing impact of changes to controlled documents or project scope
Ability to combine and interpret data from multiple disciplines for a project
Strong prioritization skills and ability to suggest alternatives or contingencies for technical solutions
Ability to propose deviations from established procedures based on sound judgment
Excellent written and verbal communication skills with internal and external customers
Ability to communicate technical information to non-technical audiences
Ability to learn and retain technical information
Leadership development and supervisory skills expected
Ability to assess new technologies and their impact on offerings
Lead by example according to company values and culture
Ability to assess training needs and create development plans for subordinates
Ability to anticipate and identify unmet customer needs based on technical skills and drug development experience
Ability to interpret and provide instructions in various formats
Understanding of regulatory CMC filing package elements and required documentation
Well organized with ability to multitask
Ability to work effectively under pressure to meet deadlines
May publish or present externally

Nice To Haves

Master’s degree in a related life science or physical science field with 9+ years of related work experience preferred
Doctorate degree in a related life science or physical science field with 5+ 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
Author and approve technical documents such as protocols, test methods, reports, certificates of analysis and operating procedures
Review technical documents for accuracy, completeness and regulatory compliance
Train, coach and mentor others on technical, personal development or business issues
Supervise technical staff, including work assignments and performance management
Act as technical lead on one or more projects, responsible for project outcomes and customer interaction
Develop and execute efficiency improvement projects
Identify and recommend business opportunities on a project-specific basis
Apply technical and functional knowledge to design experiments, processes and formulations that contribute to the group
Participate in client interactions during team and ad hoc meetings with minimal supervision
Maintain high-quality laboratory documentation in accordance with regulatory guidance and site procedures
Perform all other duties as assigned