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Senior Scientist - TSMS
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BioSpace 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 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. Overview
Organization Overview: Join the energetic and growing API-EM (Active Pharmaceutical Ingredient - External Manufacturing Organization) that delivers a diverse portfolio of medicines essential to patients around the world. The API EM TS/MS Sr. Scientist will provide technical and scientific expertise within a dynamic external manufacturing environment. The Sr. Scientist is responsible for providing technical support to achieve the reliable and compliant manufacture of API drug substance at external contract manufacturing groups to predetermined global quality standards. This person interacts daily with a wide variety of people, primarily external partners, team members and site management. The candidate will be responsible for process monitoring, response to issues, and improvements where necessary. A strong understanding of manufacturing principles and Lilly systems is required to ensure those same standards are applied to the external contract manufacturers. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards. The position requires working cross-functionally within the site and other functions to deliver on technical objectives. Key Objectives/Deliverables
Provide technical oversight and stewardship for peptide 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 peptide 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. Basic Requirements
Bachelors in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Chemistry/Biochemistry strongly preferred) 3+ years of demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations. Additional Preferences
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 Additional Information
Some travel Some off-shift work (night/weekend) may be required to support 24/7 operations Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status). Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Note: this is for accommodation requests as part of the application process. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE, Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble. Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600. Full-time employees are eligible for a company bonus and a comprehensive benefit program including 401(k), pension, vacation, medical/dental/vision, flexible benefits, life insurance, time off, and well-being benefits. #WeAreLilly Seniority level: Mid-Senior level Employment type: Full-time Job function: Research, Analyst, and Information Technology Industries: Internet News Referrals increase your chances of interviewing at BioSpace by 2x Get notified about new Senior Scientist jobs in Indianapolis, IN.
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Senior Scientist - TSMS
role at
BioSpace 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 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. Overview
Organization Overview: Join the energetic and growing API-EM (Active Pharmaceutical Ingredient - External Manufacturing Organization) that delivers a diverse portfolio of medicines essential to patients around the world. The API EM TS/MS Sr. Scientist will provide technical and scientific expertise within a dynamic external manufacturing environment. The Sr. Scientist is responsible for providing technical support to achieve the reliable and compliant manufacture of API drug substance at external contract manufacturing groups to predetermined global quality standards. This person interacts daily with a wide variety of people, primarily external partners, team members and site management. The candidate will be responsible for process monitoring, response to issues, and improvements where necessary. A strong understanding of manufacturing principles and Lilly systems is required to ensure those same standards are applied to the external contract manufacturers. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards. The position requires working cross-functionally within the site and other functions to deliver on technical objectives. Key Objectives/Deliverables
Provide technical oversight and stewardship for peptide 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 peptide 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. Basic Requirements
Bachelors in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Chemistry/Biochemistry strongly preferred) 3+ years of demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations. Additional Preferences
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 Additional Information
Some travel Some off-shift work (night/weekend) may be required to support 24/7 operations Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status). Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Note: this is for accommodation requests as part of the application process. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE, Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble. Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600. Full-time employees are eligible for a company bonus and a comprehensive benefit program including 401(k), pension, vacation, medical/dental/vision, flexible benefits, life insurance, time off, and well-being benefits. #WeAreLilly Seniority level: Mid-Senior level Employment type: Full-time Job function: Research, Analyst, and Information Technology Industries: Internet News Referrals increase your chances of interviewing at BioSpace by 2x Get notified about new Senior Scientist jobs in Indianapolis, IN.
#J-18808-Ljbffr