The Principal Scientist provides sales support, presents to clients, participates in technical meeting. This position is a highly visible, client-facing position.
Daily supervision of manufacturing associates including
prioritizing and directing daily activities as necessary
resolution of problems/issues
equipment and personnel scheduling
Conduct appropriate performance management processes, including goal setting and biannual performance assessments. Provide appropriate feedback to employees in both oral and written form.
Lead author on manufacturing compliance documents (deviations, investigations, CAPA's, formulation/manufacturing history reports, annual product technical reports, SxP's).
Participate in interviewing and hiring process of new associates
Train and mentor new associates and scientist
Represent Catalent as manufacturing SME on project team
Author Batch Production Records for clinical manufacture of Phase I through Phase III clinical supplies
Design and execute experiments and processes necessary for developing formulations of pharmaceuticals oral solid dosage forms.
Ordering supplies, materials and scheduling of equipment and rooms for manufacturing clinical supplies.
Create formulation development/manufacturing scope of work document and assist in pricing new work.
Provide support for sales activities including presenting site capabilities to potential clients, attending technical meetings, sales ride-a-longs with account managers, etc.
Identify need and submit capital requests for manufacturing equipment and instruments as necessary; generate and perform IQ/OQ/PQ for onboarding equipment.
Work with Manager or Director to determine appropriate timing for completion of work.
Work with Manager or Director to determine resource allocation.
Clear understanding of related SOPs and cGMPs (in appropriate geographies) as necessary to accomplish daily tasks.
Adheres to all company policies.
- Attend assigned Operation's department meetings.
Communication Responsibilities/Organizational Relationships
Open and clear communication with direct reports.
Communicates clearly with internal and external clients, both verbal and written.
Listens carefully to others and responds appropriately
Facilitates employee engagement by cooperating with co-workers in a team environment. Willingness to contribute to team activities.
Demonstrates ability to multi-task when organizing work and setting priorities
Good time management skills when managing associates in their daily activities.
United States-MO-Kansas City
Development & Clinical Services
PhD is required.
PhD in a science-related discipline (pharmaceutics, pharmacokinetics, chemical engineering) is preferred.
At least five years' experience with formulation development of solid oral dosage forms is required.
At least 5 years post-doc work experience in a science-related discipline (pharmaceutics, pharmacokinetics, chemical engineering) is required.
Outstanding communication skills are required.
Experience working in a GMP regulated environment is required.
Experience working with roller-compaction is preferred.
Experience working with sustained-release is preferred.
Experience with pharmaceutical techniques such as granulation, compression, encapsulation is preferred.
Experience working in a contract manufacturing setting is preferred.
Experience managing/supervising /or mentoring others is preferred.
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 employs approximately 8,500 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and in Fiscal 2013 generated more than $1.8 billion in annual revenue. 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 [email protected]. 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.