Catalent Pharma Solutions Scientist in Kansas City, Missouri
The Kansas City Development and Analytical Solutions Scientist serves as Technical Lead for formulation design and development of oral solid dosage forms. Design and execute experiments and processes necessary for developing formulations of pharmaceuticals oral solid. Lead clinical trial manufacturing endeavors and ensures that all work is carried out in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs).
II. Essential Functions:
Develop and execute laboratory work plans/schedules independently, using customer milestones and Division/site performance standards and metrics
Authors technical documents, such as protocols, batch records, test methods, technical reports, and operating procedures
Review technical documents for accuracy, thoroughness and regulatory compliance
Trains, coaches or mentors others on technical, personal development or business issues
Directs work of technical staff, including work assignments and performance management
Responsible as Project Technical Lead with responsibility for project outcome and customer interaction
Knowledge of high-shear granulation, fluid-bed technology, roller compaction, compression, encapsulation
Executes efficiency improvement project with guidance
Identify and recommend business opportunities on a project specific basis
Has advanced knowledge of the principles, theories and concepts applicable to a wide range of work in pharmaceutics and broad knowledge of principles and concepts in other disciplines.
Applies technical and functional knowledge to assist in experiment/project design that will enable department to meet goals.
All other duties as assigned
Education or Equivalent:Bachelor’s Degree in Pharmaceutics, Biology or Chemistry or closely related physical science or life science with 2 years of experience in pharmaceutical industry; OR Master's Degree with 0 years of experience required.
Hands on experience in oral solid dosage form development and manufacturing preferred
Knowledge of techniques in design of experiments and statistics
Maintain cGMP and Good Documentation Practices in accordance with applicable regulatory guidance and Site SOPs
Ability to learn and retain technical information
Proactively address work issues at both an individual level and a team level
Develop and execute complex procedures or methods with high quality
Becoming familiar with drug development milestones and their context
Recognizes and elevates changes in project scope or execution for review by project director
Able to prioritize and suggest alternatives or contingencies to achieve the correct technical solutions with most efficient resource utilization
Propose deviations from established procedures and methods based upon sound judgment.
Excellent written and verbal communications skills with internal and external customers
Supervisory skills are expected for Scientists with direct reports
Can organize and manage teams chartered to address resolution of manufacturing issues or special projects with general management guidance.
Lead by example according to Catalent's values and culture
Can assess training needs and formulate development plans for subordinates
Recognize unmet customer needs
Can effectively back-up supervisor to address limited technical or business issues with prior instructions
Strategy is focused on personal and team time management and efficiency
Well organized with ability to multitask
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 8 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
Collaborative and inclusive
Professional Office setting
Individual’s primary workstation is located in the office area or manufacturing areas where the noise level is low to moderate.
To perform this job successfully, an individual must be able to perform each duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description reflects the general duties of the job but is not a detailed description of all duties which may be inherent to this position. Catalent may assign reasonably related additional duties to individual employees, consistent with company policy.
Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com
More products. Better treatments. Reliably supplied.™
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.
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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.
Organization: Advanced Delivery Technologies (ADT)
Location: MO-Kansas City
Requisition ID: 0020191