BioSpace
Overview
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 work to discover and bring life-changing medicines to those who need them, improve understanding and management of disease, and support communities through philanthropy and volunteerism. We’re looking for people who are determined to make life better for people around the world. Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The API EM Senior or Principal Scientist will join the Technical Services/Manufacturing Sciences (TS/MS) team to provide technical support and scientific expertise across Peptides and Oligonucleotides (TIDES). The Senior/Principal Scientist acts as an SME 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 external partners, process team members and site management. The candidate will be responsible for technical transfer, process stewardship, process monitoring and will demonstrate a proactive attitude to issue resolution. A strong understanding of manufacturing principles and Lilly systems is required to ensure those standards are applied to external contract manufacturers. The incumbent would preferably possess an investigative mindset and be skilled at critical thinking with a preference for collaborative working. 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. Responsibilities
Provide technical oversight and stewardship for peptide and/or oligonucleotide manufacturing processes. Lead resolution of technical issues including those related to control strategy and manufacturing. Use excellent communication skills to manage internal and external relationships, perform effective investigations and disseminate actionable outputs. Build and maintain relationships with development partners and central technical organizations. Ensure proper characterization of processes and effective documentation and justification of the process description, measures, acceptable ranges, and specifications. Experience with advanced data analytics to ensure that Proven Acceptable Ranges (PAR) and Normal Operating Ranges (NOR) align with process capability. Ensure processes are compliant, capable, in control, and maintained in a validated or qualified state through process monitoring. Identify leading signals of process weakness and proactively resolve/escalate. Justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose. Initiate deviation records and ensure on-time closure of open records with appropriate CAPAs and effectiveness checks; demonstrate a structured approach to problem solving and investigation. Support regulatory submissions with technical input as required; author and review annual reports to regulatory agencies and maintain awareness of regulatory best practices. Influence and implement the network technical agenda and drive continuous improvement with appropriate change controls in place. Maintain peptide/oligonucleotide processes in a state of compliance with US and global regulations. Understand the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment. Operate with a team mindset, including coaching and mentoring of peers and other scientists. Qualifications
Bachelors in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Chemistry or Biochemistry strongly preferred) 3+ years of demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations. Preferences
Knowledge and experience with regulatory requirements Enthusiasm for change, 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 cross-functional tasks Demonstrated Project Management skills and ability to coordinate complex projects Additional Information
Some travel may be required Some off-shift work (night/weekend) may be required to support 24/7 operations Qualified candidates must be legally authorized to work in the United States. Lilly does not anticipate providing sponsorship for employment visa status. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form for further assistance. Lilly is 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 location. The anticipated wage for this position is $66,000 - $171,600. Full-time employees are eligible for a company bonus and a comprehensive benefits program. #WeAreLilly Job specifications
Seniority level: Mid-Senior level Employment type: Full-time Job function: Research, Analyst, and Information Technology Industries: Internet News
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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 work to discover and bring life-changing medicines to those who need them, improve understanding and management of disease, and support communities through philanthropy and volunteerism. We’re looking for people who are determined to make life better for people around the world. Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The API EM Senior or Principal Scientist will join the Technical Services/Manufacturing Sciences (TS/MS) team to provide technical support and scientific expertise across Peptides and Oligonucleotides (TIDES). The Senior/Principal Scientist acts as an SME 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 external partners, process team members and site management. The candidate will be responsible for technical transfer, process stewardship, process monitoring and will demonstrate a proactive attitude to issue resolution. A strong understanding of manufacturing principles and Lilly systems is required to ensure those standards are applied to external contract manufacturers. The incumbent would preferably possess an investigative mindset and be skilled at critical thinking with a preference for collaborative working. 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. Responsibilities
Provide technical oversight and stewardship for peptide and/or oligonucleotide manufacturing processes. Lead resolution of technical issues including those related to control strategy and manufacturing. Use excellent communication skills to manage internal and external relationships, perform effective investigations and disseminate actionable outputs. Build and maintain relationships with development partners and central technical organizations. Ensure proper characterization of processes and effective documentation and justification of the process description, measures, acceptable ranges, and specifications. Experience with advanced data analytics to ensure that Proven Acceptable Ranges (PAR) and Normal Operating Ranges (NOR) align with process capability. Ensure processes are compliant, capable, in control, and maintained in a validated or qualified state through process monitoring. Identify leading signals of process weakness and proactively resolve/escalate. Justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose. Initiate deviation records and ensure on-time closure of open records with appropriate CAPAs and effectiveness checks; demonstrate a structured approach to problem solving and investigation. Support regulatory submissions with technical input as required; author and review annual reports to regulatory agencies and maintain awareness of regulatory best practices. Influence and implement the network technical agenda and drive continuous improvement with appropriate change controls in place. Maintain peptide/oligonucleotide processes in a state of compliance with US and global regulations. Understand the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment. Operate with a team mindset, including coaching and mentoring of peers and other scientists. Qualifications
Bachelors in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Chemistry or Biochemistry strongly preferred) 3+ years of demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations. Preferences
Knowledge and experience with regulatory requirements Enthusiasm for change, 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 cross-functional tasks Demonstrated Project Management skills and ability to coordinate complex projects Additional Information
Some travel may be required Some off-shift work (night/weekend) may be required to support 24/7 operations Qualified candidates must be legally authorized to work in the United States. Lilly does not anticipate providing sponsorship for employment visa status. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form for further assistance. Lilly is 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 location. The anticipated wage for this position is $66,000 - $171,600. Full-time employees are eligible for a company bonus and a comprehensive benefits program. #WeAreLilly Job specifications
Seniority level: Mid-Senior level Employment type: Full-time Job function: Research, Analyst, and Information Technology Industries: Internet News
#J-18808-Ljbffr