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Scientist TS/MS Purification

Branchburg Township, New Jersey

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Req ID 57887BR Title Scientist TS/MS Purification City Branchburg State / Province New Jersey Country United States

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Responsibilities :

This position is responsible for purification process troubleshooting and driving continuous improvement in the the TS/MS Branchburg laboratory.  Design, lead and execute laboratory experiments in support of manufacturing operations, continuous improvement, process validation and technology transfer.  This position will interact with Process Teams composed of engineering, manufacturing, validation, quality assurance, and quality control representatives.  Interaction may be required with other Lilly site / contract producers of Lilly products.  Knowledge of cell culture and/or purification and support systems used in the manufacturing of biotech products is required.

Responsible for supporting manufacturing operations through the performance of the following duties in the TS/MS Branchburg laboratory:

Laboratory Ongoing Capability & Continuous Improvement

  • Deploy laboratory process models for commercial and technology transfer candidate molecules.  Commission new laboratory equipment and continue to identify additional capabilities and/or new technologies to keep lab at optimal productivity.
  • Plan and schedule lab activities to ensure the successful and timely execution of various studies.

Developing and Mentoring Technical Competencies

  • Understand the purpose and science of the process; build deep technical expertise and demonstrate strong data-driven decision-making and problem-solving capabilities.  Make decisions that impact the function.
  • Work effectively and efficiently in a cross-functional, team-oriented environment; interact with Manufacturing Process Teams, development scientists and molecule stewards, within and across Lilly sites.  Influence others to adopt a different point of view on difficult concepts.
  • Help to mentor a team of laboratory scientists and engineers tasked with support of manufacturing operations, continuous improvement, process validation and technology transfer.

Process Support, Process Improvement, and Technology Transfer

  • Oversee and perform laboratory experiments in scale-down models designed to further understand and improve the process. Work with Manufacturing to resolve technical issues and implement corrective / preventative actions in the plant.  Anticipate and resolve key technical problems.  Drive solutions that impact the site.
  • Transfer from R&D and qualify laboratory models for late stage clinical and commercial manufacturing processes, for purification unit operations.
  • Work with R&D and Manufacturing to develop, transfer and implement well-understood, robust and fit-for-purpose process control strategies.
  • Lead large-scale program(s) or project(s) with greater risk and/or complexity.  Build relationships with internal and external partners.
  • Document and communicate work and learnings.  Prepare summary slides/memos/reports and present data to broader audiences.  Author documentation including SOPs, protocols, and reports.
  • Understand, and perform all job responsibilities in compliance with safety and regulatory expectations as well as cGMP

Basic Qualifications :

  • PhD in Chemistry, Micro/biology, Biochemistry, Bio/chemical engineering or related science.
  • Minimum of 10 years experience (including graduate education) in a cGMP biopharmaceutical or pharmaceutical manufacturing and/or development environment. 

Additional Skills/Preferences :

  • Lesser years of experience will be considered under extraordinary circumstances or where consistent high-level performance measures have been sustained.
  • Knowledge of cell culture and/or purification techniques used in the manufacturing of biotech products.
  • Ability to independently master assigned processes and to coordinate activities with a team of individuals.
  • Demonstrated leadership skills.
  • Excellent communication skills, both oral and written.
  • Experience in filtration and chromatography techniques used in the manufacturing of recombinantly expressed therapeutics.
  • Experience setting up methods, operating and troubleshooting the Akta chromatography system.
  • Experienced in statistical data analysis and knowledge of design of experiment (DoE) principles.
  • Have prior understanding of cGMP and regulatory requirements.

Information for Internal Employees :

If you are currently in a technical path role, but outside of the posting band, you may apply. You will be hired at your current level. For example: Current P4 (tech ladder), Posting R1-2 tech ladder, hire will occur at P4.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID 57887BR.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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