Eli Lilly and Company

  • Eli Lilly and Company Global Headquarters Lilly Corporate Center Indianapolis, Indiana 46285 USA
  • https://www.lilly.com
Eli Lilly and Company Indianapolis, IN, USA
Oct 18, 2019
Full time
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 Are you seeking a career that makes a difference in the world? Are you an innovative thinker who can craft strategic solutions to deliver a continuously changing portfolio? Do you seek the opportunity to demonstrate your scientific and operational knowledge to impact clinical trial design, feasibility and implementation? Have you prepared or provided technical support for clinical and regulatory documents? Do you have extraordinary problem solving skills to support scientific needs in business? We have the role for you if you are looking for your next career move. As Clinical Trial Project Manager (CTPM) Associate, you will lead the cross-functional study team in the development and execution of clinical trials. You will be accountable both regionally and globally to deliver trial(s) with quality, on time, and within scope and budget. This role requires strong project management skills, regional operational knowledge, clinical trial process leadership and expertise, and scientific expertise to drive actions and coordinate efforts to achieve or exceed these trial deliverables. You will work with diverse teams to apply creative solutions to daily issue. This will include opportunities to work with vendors, affiliates/regions, global team members and other business partners). Other experiences you will encounter in this role include: Driving and coordinating local, regional and global, cross-functional study teams throughout study implementation, execution and closure empowering them to meet the clinical trial deliverables, including issue management, contingency planning and issue resolution. Accountability for trial/regional enrollment strategy and execution starting from country allocation through Last Patient Entered Treatment (LPET) Demonstrate understanding of drug development process. Acknowledge inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall clinical trial. Look for opportunities to expand and deepen clinical trial process expertise. Acting as a single point of accountability for the Trial Master File, working closely with functional record owners to ensure the file is current and inspection ready at all time. Networking and using your expertise to anticipate trial and regional issues, identifying areas of process breakdown, assessing situations and proposing proactive approaches that reduce and/or mitigate risks that impact ability to deliver. Demonstrate ability to lead and influence in the midst of ambiguity. Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards of operation. Liaise with affiliates and other appropriate resources to understand local regulatory requirements. 53050BR Basic Qualifications Bachelors degree (scientific or health-related field) with at least 1 year of experience in a clinical setting or an advanced degree (MS, MSN, MPH, PharmD, PhD) Additional Skills/Preferences Applied knowledge of project management methodology, processes and tools (eg: Critical Chain, ProChain Enterprise, MS Project, MS Excel, MS Powerpoint) Solid ability to work cross functional and cross-cultural with global colleagues and with TPOs with strong leadership, networking skills and ability to influence without authority. Effective and influential communication, self-management, and organizational skills Demonstrated ability to handle complex situations through problem-solving, critical thinking and navigating ambiguity Flexibility to adjust to altered priorities Clinical trial experience with a strong working understanding of the clinical research process Prior clinical trial site-level or affiliate experience Need to travel periodically to AST/ ISST and potentially other scientific/ regional meetings Additional Information Ability to travel (up to 10% is expected- varies dependent on responsibilities) EEO Statement: 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.
Eli Lilly and Company Indianapolis, IN, USA
Oct 18, 2019
Full time
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. #WeAreLilly Responsibilities Are you seeking a career that makes a difference in the world? Are you an innovative thinker who can craft strategic solutions to deliver a continuously changing portfolio? Do you seek the opportunity to demonstrate your scientific and operational knowledge to impact clinical trial design, feasibility and implementation? Have you prepared or provided technical support for clinical and regulatory documents? Do you have extraordinary problem solving skills to support scientific needs in business? We have the role for you if you are looking for your next career move. As Clinical Trial Project Manager (CTPM) Associate, you will lead the cross-functional study team in the development and execution of clinical trials. You will be accountable both regionally and globally to deliver trial(s) with quality, on time, and within scope and budget. This role requires strong project management skills, regional operational knowledge, clinical trial process leadership and expertise, and scientific expertise to drive actions and coordinate efforts to achieve or exceed these trial deliverables. You will work with diverse teams to apply creative solutions to daily issue. This will include opportunities to work with vendors, affiliates/regions, global team members and other business partners). Other experiences you will encounter in this role include: Driving and coordinating local, regional and global, cross-functional study teams throughout study implementation, execution and closure empowering them to meet the clinical trial deliverables, including issue management, contingency planning and issue resolution. Accountability for trial/regional enrollment strategy and execution starting from country allocation through Last Patient Entered Treatment (LPET) Demonstrate understanding of drug development process. Acknowledge inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall clinical trial. Look for opportunities to expand and deepen clinical trial process expertise. Acting as a single point of accountability for the Trial Master File, working closely with functional record owners to ensure the file is current and inspection ready at all time. Networking and using your expertise to anticipate trial and regional issues, identifying areas of process breakdown, assessing situations and proposing proactive approaches that reduce and/or mitigate risks that impact ability to deliver. Demonstrate ability to lead and influence in the midst of ambiguity. Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards of operation. Liaise with affiliates and other appropriate resources to understand local regulatory requirements. 53039BR Basic Qualifications Bachelors degree (scientific or health-related field) with at least 1 year of experience in a clinical setting or an advanced degree (MS, MSN, MPH, PharmD, PhD) Additional Skills/Preferences Applied knowledge of project management methodology, processes and tools (eg: Critical Chain, ProChain Enterprise, MS Project, MS Excel, MS Powerpoint) Solid ability to work cross functional and cross-cultural with global colleagues and with TPOs with strong leadership, networking skills and ability to influence without authority. Effective and influential communication, self-management, and organizational skills Demonstrated ability to handle complex situations through problem-solving, critical thinking and navigating ambiguity Flexibility to adjust to altered priorities Clinical trial experience with a strong working understanding of the clinical research process Prior clinical trial site-level or affiliate experience Need to travel periodically to AST/ ISST and potentially other scientific/ regional meetings Additional Information Ability to travel (up to 10% is expected- varies dependent on responsibilities) EEO Statement: 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.
Eli Lilly and Company Indianapolis, IN, USA
Oct 16, 2019
Full time
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. #WeAreLilly Responsibilities Lilly's Small Molecule Design and Development (SMDD) is involved in key activities for the development of synthetic active pharmaceutical ingredients from pre-clinical phases through commercialization of drug substances and drug products. Our scientists develop key technical and business solutions across the portfolio using their deep technical expertise to speed up testing of the clinical hypothesis and overall drug development. SMDD tackles this diversity of responsibilities by recognizing that an even greater diversity of talents and cultures is necessary to deliver the next generation of life changing medicines to patients. SMDD is seeking outstanding engineering candidates to work within the process design and development team. The position presents an opportunity to work side by side with chemists, analytical chemists, formulation scientists and modelers to develop new technical solutions to accelerate our portfolio. The position will be based in Indianapolis where research is conducted in a new, state of the art development facility. Candidates must demonstrate a history of strong technical depth, scientific leadership and a willingness to promote a collaborative, team-based approach to problem solving. The responsibilities and opportunities for this role include: Apply chemical engineering fundamentals towards designing and optimizing drug substance/drug product processes. Design and develop novel platforms and control systems to speed up the development of synthetic molecules including small molecules, synthetic oligonucleotides and peptides. Serve as a member of integrated commercial teams responsible for the development and demonstration of new processes. Design and execute experiments in a laboratory setting and/or mathematical models to develop robust processes capable of meeting early and late phase demands. Develop the external manufacturing network, oversee activities and install key capabilities within contract manufacturing organizations (CMOs) Communicate appropriately to other functions to enable fast commercialization of drugs and to management team to enable sound business decisions. Engage in a highly collaborative work environment across and beyond SMDD and Lilly, including external academic researchers and pre-competitive collaborations. Direct and mentor less experienced scientists and engineers to deliver the portfolio and innovation projects. Publish and present original research externally, author internal technical documents and develop and document control strategies for new product registration applications (manufacturing process and development history portions). 52395BR Basic Qualifications PhD in Chemical Engineering or related discipline Additional Skills/Preferences Experience with design, development, control and optimization of unit operations Experience with modeling and simulation tools, data analytics and predictive analytics. Experience with online and offline analytical techniques and process analytical technologies (PAT). Excellent oral communication and documentation skills. Demonstrated ability to effectively collaborate with multidisciplinary teams Additional Information Lilly is an EEO/Affirmative Action Employer, and does not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status. Travel: 0 to 10%
Eli Lilly and Company Greenfield, IN 46140, USA
Oct 15, 2019
Full time
Elanco is a global animal health company that develops products and knowledge services to prevent and treat disease in food animals and pets in more than 90 countries. With a 64-year heritage, we rigorously innovate to improve the health of animals and benefit our customers, while fostering an inclusive, cause-driven culture for more than 5,800 employees. At Elanco, we're driven by our vision of food and companionship enriching life - all to advance the health of animals, people and the planet. Learn more at Responsibilities This role has overall accountability for the US Regulatory New Product Development team. The US Regulatory Affairs, Pharmaceutical Director will provide oversight and leadership for the development and execution of global regulatory strategy for pharmaceutical products relating to Safety and Efficacy. Drive delivery of regulatory excellence for innovation projects and support geographic expansion and post approval needs globally. Facilitate development of Elanco's RA skills and effectively coordinate resources to efficiently execute regulatory submissions in collaboration across the Elanco functions; in particular, the regulatory teams, research and development teams, and commercial business units as well as external global regulatory agencies to achieve overall Elanco deliverables and to meet critical registration timelines in compliance with global regulatory standards and guidelines. Functions, Duties, Tasks: Lead the development and preparation of investigational new animal drug applications, protocols, submissions, supplemental and amended applications, general correspondence and responses to global regulatory agencies. Work in partnership with product development teams, external collaborators and commercial business units to ensure robust data packages, submissions and communications to meet internal and external stakeholder expectations. Lead the review of new product dossiers, identifying gaps and recommend submission strategies to enable timely new product registrations & speed to market Develop, maintain & negotiate directly with Regulatory Agencies and notifiable bodies, including the preparation & review of responses to questions Lead collaboration within the broader Regulatory Affairs function to maintain & acquire Pharmaceutical Marketing Authorisation Applications (MA's) Initiate, seek opportunities for, participate in and lead /contribute to RA transformational initiatives both internally and those shaping the external regulatory landscape. In collaboration with Regulatory & R&D leaders, lead and/or provide input into the regulatory strategy (pre-submission or post approval stages) for both new products; geographic expansion of existing registrations, early development projects and borderline projects Maintain an awareness of the US Regulatory landscape and changing regulatory requirements, specifically for pharmaceutical's Develop global talent to sustain local and global competitiveness. This includes identifying and / or recruiting individuals with leadership & technical leadership potential, providing mentoring and enrichment opportunities consistent with succession planning. Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies. Any other duties or projects as requested by the Line Manager commensurate with the grade and level of responsibility for this role, for which the employee has the necessary experience and/or training 53056BR Basic Qualifications Bachelor's degree 5 years exp in regulatory with 2 years in a managerial role Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position Additional Skills/Preferences Substantial experience in obtaining and maintaining product licenses, ideally within multiple markets & broad knowledge of regulatory filing strategies Substantial knowledge of current drug regulations in key markets (US, EU,) Substantial experience of dealing and negotiating directly with Health Authorities in key markets (EU, US) Demonstrated expertise of regulatory lifecycle management processes - dossier preparation, submission and monitoring of post approval commitments. Demonstrated knowledge and experience of the businesses supported including science, product lines, markets served, business strategies and business processes Demonstrated leadership skills, within a global matrix environment Experienced in interpreting regulations and policies, and responding to associated questions.with an emphasis on new molecule registrations Skilled in risk-assessment methodologies, and project organization. Ability to handle multiple tasks and appropriately manage priorities for self and organization Able to define problems, collect and review data, establish facts and draw valid conclusions. Ability to evaluate metrics and trend data to drive robust continuous improvement plans. Demonstrated ability to effectively communicate and collaborate across a matrix environment Fluent (written & verbal) in English Additional language skills would be highly valued - but not essential Desired, Masters or PhD in Physical, Chemical, or Life Sciences or Management GxP knowledge and experience, would be highly valued Additional Information Up to 25% Domestic and International travel required Elanco 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
Eli Lilly and Company Greenfield, IN 46140, USA
Oct 11, 2019
Full time
Elanco is a global animal health company that develops products and knowledge services to prevent and treat disease in food animals and pets in more than 90 countries. With a 64-year heritage, we rigorously innovate to improve the health of animals and benefit our customers, while fostering an inclusive, cause-driven culture for more than 5,800 employees. At Elanco, we're driven by our vision of food and companionship enriching life - all to advance the health of animals, people and the planet. Learn more at Responsibilities The Research Associate will use their skills and knowledge to optimize biopharmaceuticals and vaccines fermentation processes. The incumbent will participate in large molecule process development efforts (e.g., enzymes, vaccines, monoclonal antibodies etc.). S/He should be able to plan, perform, interpret and report results of scientific experiments. Design, review and make recommended changes to scientific protocols and procedures. This position will be responsible for implementing R&D strategies to optimize biological processes. This position is laboratory-based and will require routine interaction with scientists across multiple discovery and core research laboratories at Elanco. The incumbent scientist will be expected to support multiple projects at any given time. The ability to independently execute experiments, coupled with a "can do" attitude, is a must Functions, Duties, Task: Support process development group with project-related activity such as microbial fermentation, cell culture, seed creation etc. Plan, execute and coordinate daily and weekly work schedule. Design, review and make recommended changes to scientific protocols and procedures. Maintain infrastructure of laboratory and an organized, clean and safe working environment. Schedule and perform maintenance of instruments/equipment. Evaluate new laboratory equipment. Use proper safety equipment and follow appropriate safety procedures. Takes responsibility for proper handling and disposal of biohazard materials and/or hazardous chemicals. Present results during team, project or unit meetings. Write reports, prepare SOPs/working procedures. Support preparation of tech transfer and registration documents. Perform data analysis and use results for the design of next experiment. Perform troubleshooting activities. Collaborate with other associates and scientists to facilitate knowledge exchange. Train and coach peers. Participate in project teams within the function. Work according to, and eventually ensure the compliance with, external and internal guidelines (e.g. SOP's, GxP, HSE, and AW). Supporting other technical development functions (e.g. analytical, DSP and formulation). Support projects from development to tech transfer in M&Q. Keep abreast of scientific literature in the field and able to provide expertise in evaluation of new platform technologies. When required, should be able to come during night/weekend and occasionally required to stay longer hours to support project work 50344BR Basic Qualifications Bachelor of Science degree in a relevant scientific discipline (chemical or bio-chemical engineering, microbiology, chemistry or biochemistry) with minimum 5 years experience working on R&D projects in human or animal health industries preferably in fermentation process development area. Masters Degree in a relevant scientific discipline (chemical or bio-chemical engineering, microbiology, chemistry or biochemistry) with m inimum 2 years experience working on R&D projects in the human or animal health industries preferably in fermentation process development area. Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position Additional Skills/Preferences Masters of Science Degree Effective oral and written communications skills. Highly focused and detail oriented, High personal ethical and quality standards. Exceptional problem solving and decision-making skills. Must be able to work productively in an interdisciplinary team environment Knowledge and experience in using ELNs. Knowledge and experience in high throughput sample design and analysis. Experience working in a pharmaceutical R&D laboratory. Experience in writing protocols and development reports. Experience with downstream processing and/or formulations of vaccines and/or therapeutic proteins a plus Additional Information Elanco 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 #LI-POST
Eli Lilly and Company Indianapolis, IN, USA
Oct 10, 2019
Full time
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 At Lilly, we unite caring with discovery to make life better for people around the world. The Biotechnology Research/ADME group is responsible for evaluating the preclinical pharmacokinetics and disposition of therapeutic proteins/peptides and monoclonal antibodies. Due to a strategic dedication to the growth of biotechnology, we are seeking a PK/PD scientist to contribute in a team environment as we leverage diverse analytical tools to characterize factors influencing the absorption, disposition, and pharmacodynamic properties of biologic therapeutics in development as drug candidates. Do you have a passion for identifying and solving scientific issues independently and within teams? Do you have experience with PK/PD modeling of large molecules? We need your skillset on our team. You will have the opportunity to: Function as a project leader in a multidisciplinary team environment with primary responsibility for the early preclinical development of antibodies and protein molecules. Integrate pharmacokinetics and PK/PD with discovery biology to define structure activity relationships guiding protein engineering strategies and optimization of protein therapeutics. Interact across groups and teams, regulatory agencies, and functional groups within drug disposition. Responsible for the design, conduct, interpretation and reporting of study results. Written and oral communication of scientific data, both internally and in the scientific community 45805BR Basic Qualifications Ph.D. in Pharmacokinetics/Pharmacodynamics or a related discipline in Pharmaceutical Sciences Experience in PK/PD modeling preferred Additional Skills/Preferences Experience using software such as WinNonlin, NONMEM and S-Plus. Industry (pharma, biotech, CRO, etc.) experience with PK/PD modeling of monoclonal antibodies, peptides/proteins or fusion proteins. Experience with oral protein delivery strategies. Experience with immunoassay and/or LC/MS methodology. Experience with drug development and knowledge of regulatory processes. Prior experience working in an interdisciplinary team. Additional Information 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.
Eli Lilly and Company Indianapolis, IN, USA
Oct 05, 2019
Full time
Lilly is the 10th largest pharmaceutical company in the world, and has been creating medicines that help improve peoples' quality of life for more than 135 years. Across the globe, we are a leader in investing in research and development and we also invest in our employees - in competitive salaries, training and development, and health. The pharmaceutical industry is a complex, rapidly changing environment and we are looking for highly capable leaders to help us continue bringing innovation to patients. If you are interested in being considered for employment at Lilly, we encourage you to review the following opportunity Responsibilities Statistical Analysis Collaborate with other statistical colleagues and study personnel to provide input to statistical analysis plans. Assist in and/or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the analysis plan, and conducting the actual analysis once a reporting database is created. Collaborate with data management in the planning and implementation of data quality assurance plans. Maintain proficiency with respect to SAS programming and statistical methodology and in applying new and varied methods. Effectively justify methods selected and implement previously outlined analysis plans. Conduct peer-review of work products from statistical colleagues. Effectively utilize current technologies and available tools for conducting the clinical trial analysis. Communication of Results and Inferences Collaborate with other statistical colleagues to write reports and communicate results. Responsible for assisting in the communication of study results via regulatory submissions, and manuscripts, as well as for communicating one-on-one with key customers. Assist or respond to regulatory queries working in collaboration with other statistical colleagues. Therapeutic Area and Systems Knowledge: Understand relevant disease states in order to enhance the level of customer focus and collaboration. Ensure replication of tools and systems, where applicable and stay informed of technological advances. Regulatory and Quality Compliance: Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable corporate, medical, local, and departmental policies, procedures, processes, and training. 51192BR Basic Qualifications Master's degree in Statistics or Biostatistics Additional Skills/Preferences Proficiency in statistical programming languages/software such as SAS, R, Spotfire, WinBUG, etc. Interpersonal/teamwork skills for effective interactions Technical growth and application with working knowledge of statistics and statistical software Self-management skills with a focus on results for timely and accurate completion of competing deliverables Creativity and innovation Demonstrated problem solving ability and attention to detail Data analysis, technology, and systems expertise Additional Information 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
Eli Lilly and Company Greenfield, IN 46140, USA
Oct 03, 2019
Full time
Elanco is a global animal health company that develops products and knowledge services to prevent and treat disease in food animals and pets in more than 90 countries. With a 64-year heritage, we rigorously innovate to improve the health of animals and benefit our customers, while fostering an inclusive, cause-driven culture for more than 5,800 employees. At Elanco, we're driven by our vision of food and companionship enriching life - all to advance the health of animals, people and the planet. Learn more at Responsibilities Elanco is seeking a PhD level technical leader in the Pharmaceutical, Vaccine, Science and Technology (PVS&T) group for Large Molecule Process Development (Vaccines, Biotherapeutics and Nutritionals). The primary responsibility of this role will be to set the fermentation strategy in order to drive and continuously improve upon the existing/new processes and to fully characterize Elanco's early and late phase Large Molecule fermentation product related portfolio. The Fermentation scientist will lead and directly work with a team of scientists and technical staff. The ideal candidate will provide technical coaching as well as hands-on training, in-the-lab technical leadership, and assist in all of PVS&T's fermentation network. This position will work closely with the Downstream, Formulations and Analytical scientists to support the advancement of the portfolio as well as to drive new innovations and platform capabilities. They will drive a culture of innovation driven by a strong knowledge of fermentation science. Additional core responsibilities include: Ensuring completeness and technical quality of the research work to ensure integrity of data generated in the laboratory. Supporting regulatory and quality initiatives and working collaboratively with and advice internal Elanco business partners. Background in statistics: DOE designs and data analysis. Implementation of computer and lab scale modeling for the team. Setting scale up/manufacturing process strategy and identifying and evolving Elanco's future capabilities. This role primarily supports development mode activities but they may also help to build and maintain some GMP capabilities and support manufacturing when required. The ability to independently execute experiments, coupled with a "can do" attitude, is a must Functions, Duties, Task: Independently apply scientific knowledge to develop highly robust and consistent fermentation manufacturing processes for the Elanco large molecule portfolio. Organize and direct operations of the upstream processing team to satisfy multiple project requirements in a timely manner with high quality data. Apply Quality by Design (QbD), Design of Experiment and data analysis for evaluation of multiple factor interactions to optimize quality and yields in vaccine manufacturing processes to ensure maximum customer satisfaction. Serve as SME for Upstream Processing and collaborate with different functional groups PVST, ERL, TS/MS and M&Q at Elanco. Write tech transfer report and work with M&Q to implement process. Support process development group with other project-related activity, such as Downstream Processing, Formulations and Analytics. Plan, execute and coordinate daily and weekly work schedule. Design, review and make recommended changes to scientific protocols and procedures. Maintain infrastructure of laboratory and an organized, clean and safe working environment. Schedule and perform maintenance of instruments/equipment. Evaluate new laboratory equipment. Use proper safety equipment and follow appropriate safety procedures. Takes responsibility for proper handling and disposal of biohazard materials and/or hazardous chemicals. Able to organize, interpret and present results to peers, cross-functional teams and senior leadership Write reports and may write external publications. Prepare SOPs/working procedures. Support preparation of registration documents. Conceive, plan and execute technical projects to develop robust, repeatable and scalable processes. Perform data analysis and use results for the design of next experiment. Able to perform troubleshooting activities. Collaborate with other associates and scientists to facilitate knowledge exchange. Expand and strengthen the network of subject matter expertise internally and externally. Train and coach peers. Work according to, and eventually ensure the compliance with, external and internal guidelines (e.g. SOP's, GxP, and HSE). 52804BR Basic Qualifications PhD in Biotechnology, Biological sciences, Engineering or related fields. Minimum two years of postdoctoral and/or industrial experience in biotechnology working on the development of bacterial fermentation processes from bench to pilot scale. Additional Skills/Preferences Thorough knowledge in bacterial fermentation and assessment of bacterial growth and product characterization by microbiological or suitable analytical techniques. Keep abreast of scientific literature in the field and able to provide expertise in evaluation of new platform technologies. Advanced knowledge of laboratory and/or technical tools. When required, should be able to come during night/weekend and occasionally required to stay longer hours to support project work Experience in process development following QbD principles Knowledge in mammalian cell culture and assessment of growth and product characterization. Experience with downstream processing and/or formulations of vaccines and/or therapeutic proteins. Advanced knowledge of English (oral and written). Good presentation and scientific/technical writing skills. Requires ability to lift 25 pounds and ability to stand for long periods of time Additional Information Elanco 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. #LI-POST
Eli Lilly and Company Indianapolis, IN, USA
Sep 28, 2019
Full time
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 You will be responsible for asset level clinical data strategy including an in depth understanding of data sciences, data collection, data flow management, data quality & integrity, data technology, data archiving, data standards, and data submissions. You will help drive elements of clinical research from early clinical development to post launch clinical research activities. Collaborate with study partners to develop strategies and solutions to deliver data required to answer scientific questions during the drug development life cycle of the molecule. Meet current and emerging business needs (e.g. adaptive designs, tailored therapeutics, quantitative pharmacology, eCOA, connected devices, and electronic health records) through understanding and incorporating various techniques, approaches and data sources into the strategy. The Consultant role is responsible for providing clinical data strategy, leadership, and ownership for a particular set of trials, indications, assets, or programs. As the strategy is developed, you will consult and influence the application of the meaningful sourcing strategies to meet the needs of the clinical data strategy. Primary Responsibilities: 1. Portfolio Data Strategy Develop, communicate and drive implementation of a global clinical data strategy aligned with global clinical plans for an asset. Partner with the other teams to ensure clinical data strategies are understood and effectively incorporated into clinical plans, protocols, data standards and plan documents. Positive relationship with Clinical Laboratory and Data Sciences leadership. Provides input for implementing the asset strategy via the clinical plan. Develop and ensure that deep knowledge of internal, external and regulatory requirements/expectations relevant to the data domain are understood, well communicated and applied to data deliverables. Understand and influence functional sourcing strategies to meet the needs of clinical data strategies. Utilizes external benchmark data to inform the clinical plans and designs for the data strategy. Define and approve data quality and submission deliverables. Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data strategies. 2. People Development Provide mentoring within the organization that fosters inclusion and innovation, continual improvement, and an external understanding and awareness. Model the Lilly leadership behaviors. 3. Shared learning and continuous improvement Focus on asset and therapeutic area findings to identify and replicate the most effective methodologies. Continually seek and implement means of improving processes to reduce cycle time and decrease work effort Provide functional representation in cross-functional initiatives. Actively participate in shared learning across Clinical Labs and Data Sciences organization. Work with partners to increase vendor/partner efficiencies. 4. Asset Protection Understand the confidential nature of company information and takes necessary steps to ensure its protection. Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to CROs or other outside parties. Accept obligation to Lilly for compliance to the integrity of the company. Complete readings of any policy/procedure updates including global medical, functional, and local policies and procedures 51776BR Basic Qualifications Bachelor's degree 5 years of experience in clinical drug development with expertise in clinical data management or areas intersecting with clinical data management. Upper level coursework in genetics, molecular cell biology, biochemistry and cell physiology Minimum of 2 years of laboratory experience in a biological research, anatomical pathology, or molecular biology lab Proficiency in Excel and writing documents in Word Additional Skills/Preferences Masters degree in molecular biology, biochemistry or cell biology Laboratory experience performing DNA sequencing, RNA sequencing, immunohistochemistry, RT-PCR and enzyme based assays Experience in biomarker assay validation Automated data review tool experience Knowledge of cancer cell biology and common driver mutations Proven knowledge of drug development processes. Deep therapeutic and molecule knowledge in the specific area of the role. Proven capability to understand and apply clinical data flow, data quality, data interchange, data mining, and data representation principles. Proven ability to set and implement strategies and plans to improve complex drug development processes and capabilities. Society of Clinical Data Management certification. A strong understanding of the clinical drug development processes and the interdependencies of the various tasks/functions. Ability to anticipate and resolve key technical, operational, or business problems. Additional Information 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.
Eli Lilly and Company Indianapolis, IN, USA
Sep 26, 2019
Full time
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. #WeAreLilly Responsibilities Have you wanted to work in clinical research using your ability to analyze medical images? Do you have a desire to contribute to pharmaceutical research as a core member of an Imaging Research and Development team? Lilly is looking for a dynamic scientist to join our team. Do you have strong communication, interpersonal, teamwork, and organizational skills? Have you supported clinical trial research? You will use your image analysis skills to provide technical insight to support of the clinical therapeutic portfolio. You will be computationally adept and responsible for the design, image analysis and interpretation of medical imaging in clinical trials. You will apply experience in image analysis, processing, and modeling and work cross-functionally within Lilly as well as with external imaging collaborators. We are looking for an independent, flexible and innovative scientist to work collaboratively to advance clinical image analysis and research improving the lives of our patients. In this role your responsibilities will include: Provide strategic and technical input on the development, implementation and quantitative evaluation of imaging biomarker analysis techniques in various phases of clinical development across therapeutic areas such as Oncology, and, in particular, Immuno-Oncology. Design and implement customized multi-modal image analysis (segmentation, registration, abnormality characterization) pipelines, leveraging between novel strategies and standard methodologies. Assess CT, MRI and/or PET image analysis as diagnostic and treatment response biomarkers Implement emerging technologies including computer vision, neural networks, unsupervised/supervised learning Collaborate cross-functionally with internal research and clinical (medical, operations, statistics, regulatory) teams as well as external CROs to support the validation of imaging biomarkers and their application in therapeutic development. Evaluate emerging imaging technologies, capture and communicate scientific intelligence, identify key scientific developments and implement them in the image analysis pipelines Contribute to design, editing, writing and reviewing protocols and technical imaging documents (e.g., technical manuals, imaging review charters). Communicate, present and publish results of research projects and clinical trials as appropriate. Independently conduct all stages of the projects with minimal supervision. 52634BR Basic Qualifications PhD in Medical Imaging, Biophysics, Biocomputing or related discipline with applicable training or experience utilizing medical image analysis using CT, PET and/or MRI or Master's degree in Medical Imaging, Biophysics, Biocomputing or related discipline with minimum of 5 years of professional experience utilizing medical image analysis using CT, PET and/or MRI Additional Skills/Preferences Evidence of your direct role and contribution to the medical image analysis field. This may include publications in peer-reviewed scientific journals, presentations at imaging-related conferences and/or developed software codes. Participation in oncology clinical trials and implementation of CT, MRI, and/or PET/CT treatment monitoring image analysis for immuno-oncology and other therapies. Knowledge of CT, PET and MRI procedures and acquisition protocols Implementation of emerging technologies including machine learning and artificial intelligence to the advanced tumor imaging analysis. Experience working with programing languages (MATLAB, R, etc.), image processing instruments (PMOD, etc.), and deep learning tools Statistical analysis of imaging data and experience in using statistical software tools Additional Information Ability to travel 5-10 % 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
Eli Lilly and Company Greenfield, IN 46140, USA
Sep 25, 2019
Full time
Elanco is a global animal health company that develops products and knowledge services to prevent and treat disease in food animals and pets in more than 90 countries. With a 64-year heritage, we rigorously innovate to improve the health of animals and benefit our customers, while fostering an inclusive, cause-driven culture for more than 5,800 employees. At Elanco, we're driven by our vision of food and companionship enriching life - all to advance the health of animals, people and the planet. Learn more at Responsibilities This role contributes to the preclinical development of novel food and companion animal health products by planning, coordinating, and implementation of pilot formulation studies in compliance with good research practices (GRP) and guidelines. This includes authoring of study protocols, designing and conducting drug physicochemical characterization studies (e.g., stability, particle size, solubility, excipient interaction, dissolution) in-house or via CROs, and providing technical oversight preclinical formulation development activities conducted by CROs/CMOs and internal. This position will be responsible for preclinical, enabling formulation development activities based on knowledge of molecular properties of the active pharmaceutical ingredient (API), preformulation experiments, and will include implementing innovative approaches to support the preclinical development of novel products used in studies via premixes, injectables, suspensions, spray-dried coatings, and formulated material in capsule Functions, Duties, Tasks: Proactively search for solutions, challenge current default practices, and present effective alternatives for product design and development Work effectively and flexibly within and across all Elanco R&D teams and collaborate with key research partners in efficacy, pharmacology, ADME, and toxicology Represents research on core teams focused on the discovery and selection of compounds for clinical and commercial development. Create a positive work environment that is aligned with company objectives. Providing technical advice and guidance to other teams and business areas. Defines the initial product concept and works with development colleagues to estimate the cost of production Manage project timeline and budget deliverables to facilitate delivery of the Elanco pipeline. Possess a strong background in formulation development, oral drug delivery, biopharmaceutics and organic and physical chemistry. Leads the physicochemical and biopharmaceutical profiling and risk assessment of compounds advancing through the discovery flow schemes. Develop enabling formulations to facilitate preclinical pharmacokinetic, pharmacology and toxicology studies Analytical method development to enable stability testing for API Identify and select CROs, establish contract agreements, and maintain a positive business collaboration Understands compound/scaffold properties as they impact developability and uses the understanding to facilitate discovery efforts. Technical support for drug product delivery for early clinical assessment. Assess projects for design and product risks and use resources to mitigate/discharge those risks before they impact the project delivery timeline 51555BR Basic Qualifications advanced degree in organic or physical chemistry, pharmaceutical sciences or other related disciplines with knowledge of preformulation/developability. Experience: A minimum of 5 - 10 years relevant industry wi th M.S. or or academic experience with a Ph.D or BS degree in biology with 10-15 years of formulation experience. Additional Skills/Preferences Expertise in profiling and interpretation of physicochemical properties of pharmaceutical compounds. Design and development of preclinical enabling formulations. Basic understanding of pharmacokinetic principles and drug product/process design factors impacting in vivo performance of drug products. Basic understanding of drug delivery systems that are required to tailor the in vivo PK profiles for some drugs. Experience identifying the solid form and physicochemical properties of the drug substance necessary to provide acceptable drug product performance. Additional Information Domestic travel required (10-25%), and some international travel required ( Elanco 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
Eli Lilly and Company Greenfield, IN 46140, USA
Sep 25, 2019
Full time
Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 6,000 employees worldwide. Our worldwide headquarters and research facilities are in Greenfield, Indiana, and we have regional R&D hubs in Australia, Brazil and Europe. Responsibilities The Principal Research Scientist will manage safety activities in defined team projects, most normally but not exclusively, those activities related to environmental safety in farmed fish medicines. The Principal Research Scientist will ensure optimal output from associates within Elanco, and contractors, assigned to support the experimental programs and ensure that requirements for project plan timelines, budgets, risk management and GLP are met, and Standard Operating Procedures are observed. Additionally, the Principal Research Scientist is available to provide expert advice and guidance to other project teams on study design, experimental conduct, data interpretation and documentation. The Principal Research Scientist may also provide advice and guidance on marketed veterinary medicinal products and provide specialist assessments for commercial business units and their customers. The Principal Research Scientist will participate in appropriate Community of Practice groups, will mentor junior Safety scientists within the Elanco business and represent Elanco at meeting with industry and regulators Functions, Duties, Tasks: Define, plan and lead activities related to safety (most normally environmental safety) during new product development and for marketed veterinary medicinal products. Develop and maintain superior expert knowledge in the area of environmental safety. Devise, plan, monitor and coordinate safety-related studies, review reports and ensure compliance with regulatory needs in consideration of external and internal guidelines (e.g. Quality, Standard Operating Procedures, GLP, HSE and animal welfare). Interpret data and draw relevant conclusions. Prepare and maintain Environmental Safety Expert Reports or similar related documentation for international regulatory submissions. Support and defend dossiers and negotiate critical issues related to safety with regulatory authorities. Contribute to the optimization of project related scientific/technical activities and processes within the Safety function. Develop and evaluate new scientific technologies, platforms and procedures. Contribute to the planning and conduct of efficacy studies. Participate, as a technical expert, in industry groups including those mandated to write international guidelines, position papers and other related documents. Mentor junior scientists within the Elanco business. Perform other such related and reasonable duties as may be required by Elanco from time to time and that are within capabilities. 52539BR Basic Qualifications PhD or equivalent with minimum 10 years' relevant experience in environmental safety. Experience in the development of fish medicines is a plus. Additional Skills/Preferences Recognized scientific/technical expertise in a specific safety-related area and a broader scientific and strategic background. Able to understand and interpret data from relevant documents to assess environmental safety. Keep up-to-date on national and international regulatory requirements. In depth knowledge of GLP. Proven track record of creativity, problem solving and productivity in projects. Broad and in-depth understanding of research and development processes. Excellent presentation skills and scientific/technical writing skills. Demonstrated successful experience in working in interdisciplinary teams. Demonstrated scientific leadership skills in solving highly complex or high-risk project/technical issues. Demonstrated effective communication skills being able to adapt style to suit specific audiences. Demonstrated Values and Behaviors expected within Elanco Appropriate years of experience in a related research environment, and scientific and entrepreneurial thinking Additional Information Travel Percentage - Approx. 10 - 20% Elanco 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