Jobs in Kinsale, Virginia

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Principal Chemist - Analytical

Eli Lilly and Company Kinsale, VA

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. Organization Overview At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges. The Analytical Technical Steward in API (Active Pharmaceutical Ingredient) External Manufacturing Quality Control is a technical position helping to ensure that the analytical testing of products at multiple sites meets both Lilly and external requirements and is executed consistently to predetermined standards. The Analytical Technical Steward reviews data released by contract manufacturers according to API EM Risk Based Oversight Governance to ensure it meets internal integration and data integrity expectations, reviews deviations for trends, reviews and/or releases stability data, and leads resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results. They may perform non-routine lab work in support of this. Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional internal and joint process teams. The Analytical Technical Steward works closely with development counterparts and GQL (Global Quality Laboratories) to ensure robust analytical control strategies are established for molecules they support. Responsibilities: Technical review, interpretation, and release of data including data released from CM (Contract Manufacturers), stability, process validation, and reference standard characterization. Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. Develop investigational testing protocols and perform testing as required. Contribute to APR, tech transfer, and process validation as required. Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners. Participate in internal/external audits as needed. Develop and ensure execution of quality plan projects. Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing. Performs method assessments, with deficiencies and areas for improvement noted within the assessments. Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed. Participates in method validations according to Global Quality Standards (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in practices). Review of analytical test method packages. Approval of test method protocols. Approval of new test methods or changes or deletions to existing test methods. Provides laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including: laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions). Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies. Improve assays in QC. These improvements include variability reduction, method optimization, and new method development. Local and Global Method Change Control Ownership. Oversight of reference standard evaluations per Global Quality Standards. Selection of appropriate packaging materials. Consult in the preparation of the characterization protocol for corporate reference standards. Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards. Participate in the review of the reference standard profile and associated documentation for data integrity. Method transfers to Contract Manufacturers. Oversee transfer of analytical methods for marketed products to CM laboratories or to designated third party QC labs. Monograph review and implementation. Ensures consistent practices between laboratories running the same methods. Effective management of multiple projects. Basic Requirements: Bachelor degree (4 year College) in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmacy) 5+ years of industry related experience in pharmaceuticals in a GMP lab (especially large molecule, small molecule or peptide) Additional Skills/Preferences: Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC and GC), spectroscopic, and compendial methods. Working LC-MS knowledge strongly preferred. Ability to work in a lab environment, including wearing appropriate PPE and following safety guidelines. Deep understanding of compliance requirements and regulatory expectations. Demonstrated accuracy and proficiency in analytical skills. Demonstrated strong problem-solving skills. Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology. Strong oral and written communication skills demonstrated through documentation and presentations. Demonstrated strong interpersonal interaction skills. Ability to work in cross functional teams as well as across networks. Demonstrated analytical skills. Demonstrated experience with method qualification, validation, and transfer. Proven ability to provide QC support for contract manufacturers of starting materials, intermediates, and APIs to include small molecules, monoclonal antibodies, synthetic peptides, and E. coli platform large molecules. Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV). Proven ability to support maintenance of Corporate Reference Standards and manage testing and reporting of results from contract manufacturers. #J-18808-Ljbffr

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Maintenance Planner-Large Molecule

TN Ireland Kinsale, VA

Social network you want to login/join with: Maintenance Planner-Large Molecule, Kinsale Client: Lilly Location: Kinsale, Ireland Job Category: Other EU work permit required: Yes Job Reference: 6dacfe7c14db Job Views: 160 Posted: 25.01.2025 Job Description: We’re looking for people who are determined to make life better for people around the world. Main Purpose and Objectives of Position: The maintenance planner is responsible for technically planning, scheduling (where applicable), coordinating and overseeing all aspects of maintenance activities within their area of responsibility. The maintenance planner will be the link between the different workstreams in the area relating to maintenance activities. The maintenance planner is the Lilly point of contact for the individual crews assigned to those areas. Lilly has a requirement for people with both electrical and instrumentation (E&I) and mechanical disciplines. In addition, the planner is responsible for controlling the maintenance work within the Computerized Maintenance Management System (CMMS) and ensuring activities are carried out, recorded and ready for inspection by external and internal regulatory auditors always. Key Responsibilities: Ensure all maintenance activities are carried out in a safe, timely and compliant manner in line with the Lilly LOTO system utilizing TOF. Participate in continuous improvement & lean 5S initiatives. Be the Point of contact for Safety & Quality related questions from craft. Troubleshoot maintenance issues within area of responsibility. Own the planning and scheduling (where applicable) of preventive and corrective maintenance activities to ensure that all preventive & corrective maintenance activities are completed as scheduled in GMARS (the CMMS) to meet Maintenance metrics requirements. Planning and documenting how work is to be completed. Ensuring spare parts are available & liaise with engineering stores. Co-ordinate the various craft disciplines and vendors to execute Maintenance activities to the highest standards & per site SOP’s. Ensure all work is documented appropriately following ALCOA+ principles. Updating of job plans to ensure accuracy. Schedule, chair & attend meetings to ensure maintenance activities are appropriately scheduled. Be the technical adviser for area of responsibility and escalate issues appropriately. Flexibility to support other areas within the Maintenance team & participate in Project and best practice initiatives within the Maintenance team. Investigate failures and propose solutions to prevent reoccurrence. First point of contact for craft personnel to troubleshoot issues/queries on the CMMS. Manage craft allocation to respond to changing priorities. Minimum Requirements: 2+ years pharmaceutical/biotech industry experience in a maintenance role or equivalent experience. Educational Requirements: FETAC level 6 or equivalent in either an E&I or mechanical discipline. Key Attributes: Strong interpersonal skills Recent maintenance planning experience is an advantage. Any further education in an engineering related discipline is an advantage. Knowledge of Pharmaceutical manufacturing processes is an advantage. Strong written and verbal communication skills Ability to work on own initiative Ability to work as part of a team ‘Follow the work’ Ability to respond quickly and proactively to changing priorities. Lilly 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. #J-18808-Ljbffr

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Analytical Technical Steward-Small Molecule

Eli Lilly and Company Kinsale, VA

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. Job Description Organization Overview At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges. The Analytical Technical Steward in API (Active Pharmaceutical Ingredient) External Manufacturing Quality Control is a technical position helping to ensure that the analytical testing of products at multiple sites meets both Lilly and external requirements and is executed consistently to predetermined standards. This position will be small molecule focused. The Analytical Technical Steward reviews data released by contract manufacturers according to API EM Risk Based Oversight Governance to ensure it meets internal integration and data integrity expectations, reviews deviations for trends, reviews and/or releases stability data, and leads resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results. They may perform non-routine lab work in support of this. Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional internal and joint process teams. The Analytical Technical Steward works closely with development counterparts and GQL (Global Quality Laboratories) to ensure robust analytical control strategies are established for molecules they support. Responsibilities: Technical review, interpretation, and release of data including data released from CM (Contract Manufacturers), stability, process validation, and reference standard characterization. Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. Develop investigational testing protocols and perform testing as required. Contribute to APR, tech transfer, and process validation as required. Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners. Participate in internal/external audits as needed. Develop and ensure execution of quality plan projects. Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing. Performs method assessments, with deficiencies and areas for improvement noted within the assessments. Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed. Participates in method validations according to Global Quality Standards (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in practices). Review of analytical test method packages. Approval of test method protocols. Approval of new test methods or changes or deletions to existing test methods. Provides laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including: laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions). Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies. Improve assays in QC. These improvements include variability reduction, method optimization, and new method development. Local and Global Method Change Control Ownership. Oversight of reference standard evaluations per Global Quality Standards. Selection of appropriate packaging materials. Consult in the preparation of the characterization protocol for corporate reference standards. Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards. Participate in the review of the reference standard profile and associated documentation for data integrity. Method transfers to Contract Manufacturers. Oversee transfer of analytical methods for marketed products to CM laboratories or to designated third party QC labs. Monograph review and implementation. Ensures consistent practices between laboratories running the same methods. Effective management of multiple projects. Basic Requirements: Bachelor degree in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmacy) 5+ years of industry related experience in pharmaceuticals in a GMP lab Additional Skills/Preferences: Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC and GC), spectroscopic, KF, particle size, LOD, appearance, compendial tests, etc. Ability to work in a lab environment, including wearing appropriate PPE and following safety guidelines. Deep understanding of compliance requirements and regulatory expectations. Demonstrated accuracy and proficiency in analytical skills. Demonstrated strong problem-solving skills. Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology. Strong oral and written communication skills demonstrated through documentation and presentations. Demonstrated strong interpersonal interaction skills. Ability to work in cross functional teams as well as across networks. Demonstrated analytical skills. Demonstrated experience with method qualification, validation, and transfer. Proven ability to provide QC support for contract manufacturers of starting materials, intermediates, and APIs to include small molecules, monoclonal antibodies, synthetic peptides, and E. coli platform large molecules. Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV). Proven ability to support maintenance of Corporate Reference Standards and manage testing and reporting of results from contract manufacturers. Additional Information: Position will be day shift, but may require some shift to support global operations May require up to approximately 20% of travel overseas, passport required #J-18808-Ljbffr

Subway - Sandwich Artist (Store # 1804)

E & C Mid-Atlantic Ventures, LLC Kinsale, VA

Job Description Job Description Summary: The Sandwich Artist greets and serves guests, prepares food, maintains food safety and sanitation standards, and handles or processes light paperwork. Exceptional customer service is a major component of this position. Essential duties and Responsibilities: Exhibits a cheerful and helpful manner while greeting guests and preparing their orders. Demonstrates a complete understanding of menu items and explains them to guests accurately. Uses Point of Sale system/cash register to record the order and compute the amount of the bill. Collects payment from guests and makes change. Performs Cash-In Procedure- accounting for all forms of money, bread, etc., during the shift. Prepares food neatly, according to formula, and in a timely manner. Checks products in sandwich unit area and restocks items to ensure a sufficient supply throughout the shift. Understands and adheres to proper food handling, safety and sanitation standards during food preparation, service and clean up. Cleans and maintains all areas of the restaurant to promote a clean image. Understands and adheres to the 3-step method for cleaning. Understands and adheres to all quality standards, formulas and procedures as outlined in the SUBWAY Operations Manual . Maintains a professional appearance and grooming standards as outlined in the SUBWAY Operations Manual . Performs light paperwork duties as assigned. Completes University of SUBWAYcourses as directed Supervisory Responsibilities: This job has no supervisory responsibilities. E&C Mid-Atlantic Ventures, is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.