Senior Scientist, Biologics

Organization
Catalent Pharma Solutions
Job Location
Kansas City, MO
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. 
About Catalent Biologics: 
Catalent Biologics is a fast growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients.  The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI., and our market leading biologics analytical services in Kansas City and Research Triangle Park, NC.  With the recent acquisition of Redwood Bioscience in Emeryville, CA, we have added the SMARTag Antibody Drug Conjugate technology, providing a next-generation ADC platform to our biologics customers.  Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent. 
  
Working for Catalent Biologics is an opportunity to join an entrepreneurial team that is building a new business.  Catalent is aggressively growing in biologics, and is making significant investments in people and capabilities in this area.  This is a unique opportunity to join a small, fast growing business, backed by a global public company.  People joining our team will also have significant career development/progression opportunities as our business continues to grow and expand. 
  
This position is relocation eligible. 
Kansas City is a community that has a small town mentality with large city culture and amenities. A place where the cost of living is low, schools in the metro are among the best in the nation, and family includes your coworkers and neighbors.



Requirements: 

In support of large molecule therapeutics, develop and execute laboratory work plans/schedules for self and junior members of team, using customer milestones and Division/site performance standards and metrics. Sample types include in-process, release or stability.  Techniques may include any or all of the following: 
• Mammalian cell culture 
• Sterile technique 
• In vitro cell based assays (e.g. reporter gene bioassay, cell titer glo proliferation bioassay, etc.) 
• ELISA assays, quantitative and potency (fluorescence, luminescence, colorimetric, MSD) 
• Molecular biology (e.g. qPCR, PCR, etc.) 
• Kinetic binding assessment (e.g. BLI or SPR) 
• Flow cytometry 
• Other technologies/methodologies as required by management 
In support of large molecule therapeutics, perform and/or guide method validation or transfer activities.  Perform and/or guide method development activities 
Perform activities under cGMP as appropriate. 
Independently authors and approves technical documents, such as protocols, test methods, text reports, certificates of analysis, and operating procedures. 
Review technical documents for accuracy, thoroughness and regulatory compliance 
Trains, coaches or mentors others on technical, personal development or business issues 
Supervises technical staff, including work assignments and performance and development management 
Responsible as project technical lead on multiple projects, with responsibility for project outcome and customer interaction, including developing customer relationship to grow the business 
Drives improvement projects at the department level.  Identifies opportunities for improvement projects. 
Support development of business strategies across the business units. 
All other duties as assigned. 
Qualifications: 
Bachelor's degree with >10 years related experience, or equivalent education, experience and training; Master's degree with >8 years related experience; Doctorate Degree with  >4 years related experience. 
Experience: 
 • Good project management/coordination skills; Scientific background in GMP analytical and/or business background desirable; experience with S&OP; Good organizational skills; Significant experience with excel and powerpoint. 
• Actual position will be commiserate with experience 
• Advanced project management skills are routinely practiced for multiple concurrent projects of moderate complexity 
• Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs 
• Ability to learn and retain technical information 
• Advanced project management skills are routinely practiced for multiple concurrent projects of moderate 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 and can understand their application in context of pharmaceutical services offerings 
• Can provide reliable/defendable interpretations of regulatory guidances for the customer 
• Mathematical and scientific reasoning ability 
• Capable of rapid learning of unfamiliar principles or techniques with minimum training 
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form 
• Ability to work effectively under pressure to meet deadlines 
• Well organized with ability to handle multiple activities simultaneously 
• Excellent written and verbal communications skills with internal and external customers 
• Ability to communicate moderately complex technical information to non-technical audiences 
• Leadership development/ supervisory skills are expected. 
• Recommends and assists in implementation of new technologies and understands their impact on Catalent offerings 
• High personal credibility with peers and subordinates 
• Excellent motivator, well versed in team development 
• Lead by example according to Catalent's values and culture 
• Can assess training needs and formulate development plans for direct reports 
• Based on broad technical skills and drug development experience, anticipates and identifies unmet customer needs 
• Ability to interpret, provide and manage a variety of instructions furnished in written, oral, diagram, or schedule form across multiple work groups 
• Understands the details of regulatory CMC filing package and the analytical documentation required therein 
• Ability to work effectively under pressure to meet deadlines 
• May publish or present externally 
Physical Requirements: 
 • On an average 8 hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds 
• Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently 
• May require the use of a respirator 
  
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 worlds 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 [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.  If you would like to partner with Catalent to help us achieve our goals of hiring the best and the brightest talent, please email [email protected] 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.

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