Manager, Pharmaceutical Development - Kansas City, MO | Biospace
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Manager, Pharmaceutical Development

Catalent Pharma Solutions, Inc.

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Location:
Kansas City, MO
Posted Date:
6/23/2017
Position Type:
Full time
Job Code:
22178
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Development, Manager, Pharmaceutical,

Job Description


About Catalent

Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients globally. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients around the world.

Position Overview:  

The Kansas City Development and Analytical Solutions Research Manager provides leadership to managers and professional staff; Serves as Technical formulation development/ manufacturing SME for oral solid development programs; Design and execute experiments and processes necessary for developing formulations of pharmaceuticals oral solid;  Provide strategic direction for client programs; Authoring of registration protocols, reports, QbD studies; Support for investigations and risk assessments;  Trouble shooting issues encountered with Tech Transfer Activities

Essential Functions:

•   Provides leadership to managers and professional staff
•   Is accountable for the performance and results of multiple related teams
•   Develops departmental plans, including business, production and/or organizational priorities
•   Decisions are guided by resource availability and functional objectives Uses leading-edge knowledge of principles, concepts and practices and/or techniques to lead complex projects within a department/ group/team that may involve related departments/groups/ teams.
•   Applies technical, functional, business and/or industry knowledge to design experiments/projects; provide scientific consultation to the department/ discipline/group.
•   Actively contributes to the strategic direction of the department/ group by recommending expansion or curtailment of investigations on the basis of experimental results or scientific information.

Requirements


Education or Equivalent: Bachelor’s degree in Pharmaceutics, Chemistry or closely related physical or life science from a four-year university.
Experience:  5 years of experience in pharmaceutical research and development with 5 years in a managerial position

Knowledge/Skills Requirements:

•   Substantial experience in oral solid dosage form development and manufacturing preferred
•   Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs
•   Ability to learn and retain technical information on multiple topics
•   Advanced project management skills are routinely practiced for multiple concurrent projects of moderate to high complexity
•   Experienced in most aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones
•   Has substantial breadth/depth of technical acumen in multiple techniques with significant expertise in one or more techniques and can understand their application in context of pharmaceutical services offerings
•   Provides reliable/defendable interpretations of regulatory guidance for the customer and is capable of defending these positions to regulatory agencies
•   Capable of rapid learning of multiple unfamiliar principles or techniques with minimum training
•   Ability to interpret and evaluate a variety of instructions furnished in written, oral, diagram, or schedule form
•   Ability to work effectively under pressure to meet multiple deadlines
•   Well organized with ability to handle and direct multiple activities simultaneously
•   Excellent written and verbal communications skills with internal and external customers
•   Is able to lead difficult discussions with customers and drive the conversation to an acceptable resolution
•   Accountable to meet business unit revenue targets
•   Leadership development/ supervisory skills are expected.
•   Lead by example according to Catalent's values and culture
•   Recognized by internal and external customers and direct reports as a subject matter expert with high personal credibility
•   Can assess training needs and formulate development plans for direct reports
•   Works directly with Business Development to win new business (conference calls, new customer meetings, some travel)
•   Ability to interpret, provide and manage a variety of instructions furnished in written, oral, diagram, or schedule form across multiple work groups and departments
•   Understands the details of regulatory CMC filing package and the analytical and formulation documentation required therein.   Has the ability to write and review documents for regulatory filings
•   May publish or present externally

Physical Requirements:  

•   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

Business Environment:

•   Fast-paced
•   Performance driven
•   Customer focused
•   Collaborative and inclusive
•   Professional Office setting
•   Confidential department

Individual’s primary workstation is located in the office area 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.

About Catalent

Catalyst + Talent. Our name combines these ideas. From drug and biologic development services, to delivery technologies to supply solutions, our highly skilled and dedicated global team of over 9,500 is passionate about improving health and wellness by combining their personal expertise and advanced technologies to advance science and supply products of the highest quality to customers and patients around the world.

Our VISION is to be the world’s most trusted, reliable and innovative drug development and delivery partner by upholding the highest industry standards and exceeding customer expectations while driving strong, sustained growth for the company.

Our MISSION is to develop, manufacture and supply products that help people live better, healthier lives.

OUR VALUES are at the foundation of everything we do:

•          Patient First:  We put patients at the center of our work to ensure the safety, reliable supply and optimal performance of our products
•          Customer Dedication: We strive to exceed our customers’ expectations every day
•          People: We are committed to the growth, development and engagement of our people
•          Innovation: We develop and apply innovative solutions, superior technologies and continuously improved processes
•          Integrity: We demonstrate respect, accountability and honesty in every interaction
•          Excellence: We have a passion for excellence in everything we do.

Catalent. More products. Better treatments. Reliably supplied.™

Visit www.catalent.com/careers to explore career opportunities, or contact us at +1 877 503 9493

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.  If you would like to partner with Catalent to help us achieve our goals of hiring the best and the brightest talent, please email Erica.Kanka@catalent.com to learn more about becoming an approved vendor. 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.