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Sr. Scientist mAb TSMS API EM

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Lilly

1mo ago

  • Job
    Full-time
    Mid Level
  • Science
    Healthcare
  • Cork

AI generated summary

  • You need a relevant Bachelor's degree, 3+ years in pharmaceutical manufacturing, knowledge of regulatory requirements, data management skills, project management experience, and flexibility for travel and off-shift work.
  • You will oversee mAb manufacturing processes, resolve technical issues, ensure compliance, document processes, and foster relationships while driving continuous improvement and mentoring peers.

Requirements

  • Bachelors in scientific disciplines of Biotech, Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Biotech/Biochemistry strongly preferred)
  • 3+ years of demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.
  • Knowledge and experience with Regulatory requirements
  • Knowledge of data management practices across manufacturing
  • Enthusiasm for changes, team spirit and flexibility
  • Ability to influence and communicate to diverse groups on business, or technical issues within the site and function
  • Proficiency in delivering complex tasks and/or tasks that are cross-functional
  • Demonstrated Project Management skills and ability to coordinate complex projects
  • Some travel (<25%) is required
  • Some off-shift work (night/weekend) may be required to support 24/7 operations

Responsibilities

  • Provide technical oversight for monoclonal antibody manufacturing processes.
  • Leads resolution of technical issues including those related to control strategy and manufacturing.
  • Employ excellent communication skills to manage internal and external relationships.
  • Build and maintain relationships with development and central technical organizations.
  • Ensure proper characterization of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, and specifications (and the justification of these measures, acceptable ranges, and specifications).
  • Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state.
  • Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
  • Influence and implement the network technical agenda and drive continuous improvement.
  • Maintaining mAb processes in a state of compliance with US and global regulations.
  • Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
  • Operate with ‘Team Lilly’ in mind - including coaching and mentoring of peers and other scientists.

FAQs

What is the primary focus of the Sr. Scientist mAb TSMS API EM position?

The primary focus of the Sr. Scientist mAb TSMS API EM position is to provide technical and scientific expertise in the manufacture of monoclonal antibodies at external contract manufacturing organizations, ensuring compliance with global quality standards.

What educational background is required for this role?

A Bachelor's degree in scientific disciplines such as Biotech, Chemistry, Biochemistry, Biology, Pharmacy, or Engineering is required, with a strong preference for Biotech/Biochemistry.

How many years of experience are needed for this position?

A minimum of 3 years of demonstrated experience and proficiency in pharmaceutical manufacturing and a working knowledge of regulatory expectations are required for this position.

Is travel required for this job?

Yes, some travel (less than 25%) is required for this role.

Will I need to work outside of regular hours?

Yes, some off-shift work (nights/weekends) may be required to support 24/7 operations.

What skills are preferred for this role?

Additional preferred skills include knowledge of regulatory requirements, data management practices across manufacturing, project management skills, and the ability to influence and communicate with diverse groups on business or technical issues.

Will I be working with external partners?

Yes, the role involves daily interaction with a variety of people, primarily external partners, team members, and site management.

How does Lilly promote diversity and inclusion in the workplace?

Lilly is dedicated to ensuring equal opportunities and does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

What is the team culture at Lilly?

The team culture at Lilly emphasizes collaboration with a 'Team Lilly' mindset, encouraging coaching and mentoring among peers and other scientists.

How can I request accommodation if needed during the application process?

If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form on the Lilly careers website for further assistance.

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Manufacturing & Electronics
Industry
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Employees
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Founded Year

Mission & Purpose

Eli Lilly and Company is a global pharmaceutical firm dedicated to discovering, developing, and delivering innovative medicines that improve patient outcomes worldwide. Their ultimate mission is to make life better for people around the globe through high-quality healthcare solutions. The purpose of the company is to create medicines that help people live longer, healthier, and more active lives, while maintaining a commitment to ethical standards, scientific excellence, and integrity in all their operations.