Lead Scientist, Biologics - Kansas City, MO | Biospace
Get Our FREE Industry eNewsletter

Lead Scientist, Biologics

Catalent Pharma Solutions, Inc.

Apply
Location:
Kansas City, MO
Posted Date:
8/14/2017
Position Type:
Full time
Job Code:
0021621
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biotechnology, HPLC, Pharmaceutical, Scientist,

Job Description

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.

Position Overview:
The Lead Scientist works with minimum supervision, conferring with superior on unusual matters.  He/she is usually assisted by laboratory technicians/associates.  He/she demonstrates potential for technical proficiency and scientific creativity through broad assignments.  The Lead Scientist has appreciable latitude for un reviewed action or decision.  He/she may be responsible for setting and defining technical objectives and assessing results. Comply with divisional and site Environmental Health and Safety requirements.

Essential Functions:
* 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:
HPLC/UPLC techniques/methods (e.g SEC, IEX, RP-HPLC, HIC,  peptide map, glycan analysis, etc)
Karl Fischer,
Compendial assays, (i.e appearance. pH, etc)
UV-Vis
Aggregation techniques such as MFI, AUC, SEC-MALS
Other technologies/methodologies as required by management
* In support of large molecule therapeutics, perform and/or guide method validation or transfer activities.  Perform method development activities.
* Authors and may approve 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 management
* Responsible as Project Technical Lead with responsibility for project outcome and customer interaction
* Develop and execute efficiency improvement projects
* Identify and recommend business opportunities on project specific basis
* All other duties as assigned.

Requirements

Education or Equivalent:  Degree in chemistry or closely related physical science is required.

Experience:  Bachelor's degree with 9 - 10 years related experience, OR Master's degree with 6 - 8 years related experience, OR Doctorate Degree with 2 – 4 years related experience is required.

Knowledge/Skills Requirements:  
* Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs
* Ability to learn and retain technical information
Internal expert on data interpretation, applications, instrumentation and theory in at least one area of expertise.
* Consistently provides accurate data within the framework of regulatory guidance.
* Evaluate and assess impact of proposed changes to controlled documents and/or project scope
* Able to combine and interpret data from multiple disciplines for a project
* 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
* Ability to communicate basic technical information to non-technical audiences
* Leadership development/ supervisory skills are expected.
* Can assess new technologies and their impact on Catalent offerings
* Lead by example according to Catalent's values and culture
* Can assess training needs and formulate development plans for subordinates
* Based on broad technical skills and drug development experience, anticipates and identifies unmet customer needs.
* Ability to interpret and provide a variety of instructions furnished in written, oral, diagram, or schedule form.
* Understands the elements of a regulatory CMC filing package and the analytical documentation required therein.
* Well organized with ability to multitask
* Ability to work effectively under pressure to meet deadlines
* May publish or present externally.


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.

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.