Eli Lilly and Company
Principal Scientist API External Manufacturing TSMS TIDES
Eli Lilly and Company, Indianapolis, Indiana, us, 46262
Overview
Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to patients worldwide. 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 role interacts daily with a wide variety of people, primarily 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 corporate/industry standards. The role requires cross-functional collaboration 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. Employ 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 from yield/quality perspectives and proactively resolve/escalate. Understand, 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 in place. 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 team-oriented mindset, including coaching and mentoring of peers and other scientists. Basic Requirements
Bachelors in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Chemistry or Biochemistry strongly preferred) 3+ years of demonstrated experience with pharmaceutical manufacturing and working knowledge of regulatory expectations. Additional Preferences
Knowledge and experience with Regulatory requirements 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 cross-functional tasks Demonstrated Project Management skills and ability to coordinate complex projects Additional Information
Some travel required 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 (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. This is for individuals to request accommodation 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. Actual compensation will depend on 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.
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Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to patients worldwide. 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 role interacts daily with a wide variety of people, primarily 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 corporate/industry standards. The role requires cross-functional collaboration 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. Employ 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 from yield/quality perspectives and proactively resolve/escalate. Understand, 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 in place. 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 team-oriented mindset, including coaching and mentoring of peers and other scientists. Basic Requirements
Bachelors in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Chemistry or Biochemistry strongly preferred) 3+ years of demonstrated experience with pharmaceutical manufacturing and working knowledge of regulatory expectations. Additional Preferences
Knowledge and experience with Regulatory requirements 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 cross-functional tasks Demonstrated Project Management skills and ability to coordinate complex projects Additional Information
Some travel required 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 (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. This is for individuals to request accommodation 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. Actual compensation will depend on 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.
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