Lilly is known for its clinical depression drugs Prozac (fluoxetine) (1986), Cymbalta (duloxetine) (2004), and its antipsychotic medication Zyprexa (olanzapine) (1996). The company’s primary revenue drivers are the diabetes drugs Humalog (insulin lispro) (1996) and Trulicity (dulaglutide) (2014).

Operator – Formulation (Night Shift)

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$16.82 – $38.46

Responsabilities:

Clinical Research Physician

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$213,000 – $312,400

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 35,000 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.

As Clinical Research Physician (CRP), you will provide medical and scientific leadership to the business and/or therapeutic area. The CRP also provides scientific expertise and consultative support to product teams, internal Lilly partners, external organizations, regulatory agencies and external partners on medical and scientific issues. This role will include medical monitoring for one or more large, multicenter, multinational trials, as well as authoring of regulatory documents.

You will act as a scientific and medical resource for study teams, departments, and others as needed. The CRP must be aware of novel ideas, be willing to interact and learn from diverse teams. The CRP must also be mindful of and ensure that all activities of the team are in compliance with current local and international regulations, laws, guidance (for example, FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the business area’s vision.

We are looking for intellectually curious people to join our science and clinical team. You will be a dynamic innovator and problem solver whose research can improve the lives of millions. We offer outstanding opportunities to capitalize on the groundbreaking spirit that is a part of our 140+ year heritage. Although we have enjoyed many successes, our greatest legacy is the millions of lives that are impacted by our continued focus and drive.

Basic Requirements:

• Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.
• U.S. trained physicians must have achieved board eligibility or certification.
• Foreign medical graduates in U.S. based jobs, who are not U.S. board eligible or certified may be hired directly for employment in the U.S. at the discretion of the Chief Medical Officer.
• Non-U.S. trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see http://www.in.gov/pla/2799.htm
• Minimum of 2 years of clinical development experience in an industry setting, including experience with medical monitoring and/or regulatory submissions
• Fluent in English, both written and verbal communications

Additional Preferences:

• Ability to effectively function as part of a team and in a matrix environment
• Knowledge of drug development process
• Excellent communication skills, both verbal and written
• Strong experience in metabolic diseases – ideally obesity
• Comfortable with working with electronic data capture, case report forms, medical listings, Spotfire or other medical data visualization, and with interpretation of clinical trial efficacy and safety data
• Expertise in one or more areas relevant to clinical trials are strongly preferred (e.g., statistical/inferential methods, rating instruments, regulatory standards, safety assessment, investigator/site management, etc.)
• Demonstrated strong interpersonal, organizational, teamwork and negotiation skills
• Ability to influence others (both cross-functionally and within the function) to create a positive working environment
• Demonstrated success in implementing projects
• Willing to engage in limited domestic and international travel to the degree appropriate to support the business of the team
• Publication record

Additional Information:
• Location flexible but must be able to work EST standard business hours with hybrid team headquartered in Indianapolis

Clinical Research Physician Pain

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$252,000 – $369,600

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.

Responsibilities:

As Clinical Research Physician (CRP), you will provide medical and scientific leadership to the business and/or therapeutic area. The CRP also provides scientific expertise and consultative support to product teams, internal Lilly partners, external organizations, regulatory agencies and external partners on medical and scientific issues. This role will include medical monitoring for one or more large, multicenter, multinational analgesic clinical trials, phase 2 proof-of-concept and dose finding studies, as well as authoring of regulatory documents. You will act as a scientific and medical resource for study teams, departments, and others as needed. The CRP must be aware of novel ideas, be willing to interact and learn from diverse teams. The CRP must also be mindful of and ensure that all activities of the team are in compliance with current local and international regulations, laws, guidance (for example, FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the business area’s vision.

We are looking for intellectually curious people to join our clinical neuroscience team. You will be a dynamic innovator and problem solver whose research can improve the lives of millions. We offer outstanding opportunities to capitalize on the groundbreaking spirit that is a part of our 140+ year heritage. Although we have enjoyed many successes, our greatest legacy is the millions of lives that are impacted by our continued focus and drive.

Basic Requirements:

• Medical Doctor or Doctor of Osteopathy. Must be board-eligible or certified in anesthesiology, neurology, rheumatology, psychiatry, or physical medicine and rehabilitation or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.
• U.S. trained physicians must have achieved board eligibility or certification.
• Foreign medical graduates in U.S. based jobs, who are not U.S. board eligible or certified may be hired directly for employment in the U.S. at the discretion of the Chief Medical Officer.
• Non-U.S. trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see http://www.in.gov/pla/2799.htm
• Minimum of 2 years of clinical development experience in an industry setting, including experience with medical monitoring and/or regulatory submissions
• Fluent in English; both written and verbal communications

Additional Skills/Preferences:

• Ability to effectively function as part of a team and in a matrix environment
• Experience in the diagnosis and clinical management of acute and chronic pain and/or subspecialty pain medicine certification
• Clinical skills and development experience in use disorder and psychiatric populations
• Interest in early clinical development/analgesic clinical trial design
• Comfortable with working with electronic data capture, case report forms, medical listings, Spotfire or other medical data visualization, and with interpretation of clinical trial efficacy and safety data
• Knowledge of drug development process
• Excellent communication skills, both verbal and written
• Expertise in one or more areas relevant to clinical trials are strongly preferred (e.g., statistical/inferential methods, rating instruments, regulatory standards, safety assessment, investigator/site management, etc.)
• Demonstrated strong interpersonal, organizational, teamwork and negotiation skills
• Ability to influence others (both cross-functionally and within the function) to create a positive working environment
• Demonstrated success in implementing projects
• Willing to engage in limited domestic and international travel to the degree appropriate to support the business of the team
• Publication record

Quality Assurance Person in Plant – Drug Product External Manufacturing (Philadelphia, PA)

This role is responsible for providing daily quality oversight at the Contract Manufacturer (CM) site.  This role is located in person on site at the CM site the majority of the time.  Additional responsibilities include providing assistance, and guidance to issues such as deviation investigations, change control proposals, procedure/ master formula revisions, and other duties associated with daily Contract Manufacturers (CM) activities.

QA Person in Plant may be also responsible for final disposition of manufactured and/or packaged drug product batches. This role serves as DPEM QA primary contact to the CM for initial escalation and works with the JPT to ensure timely response for requests for information.  They also ensure that batches meet specifications, are manufactured/packaged in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements.

Important note: Location is at the CM manufacturing site – Philadelphia, PA

Key Objectives/Deliverables:

QA Person in Plant should understand the process and equipment for their product scope, including:

• Understanding the science behind the process and equipment so that compliance-based decisions ensure ongoing effective and efficient processes.
• Knowing how upstream/ downstream processing is affected by their process steps.
• Knowing the Operational Control Strategy (OCS) and failure modes of the process.
• Knowing the historical deviations/gaps, trends, and audit history of the process.

QA Person in Plant should provide support to the CM daily operations by:

• Levelling, reviewing, and approving of event investigations and changes.
• Ensuring implementation and effectiveness of corrective and preventative actions.
• Reviewing that practice matches procedure.
• Ensuring CM’s quality systems are compliant with applicable GMPs, Lilly quality standards and any additional local market requirement.
• Contribute to Quality culture efforts at both DPEM and CM.
• Spend time in all unit operations, including the lab.
• Provide primary oversight and guidance for minor investigations and change controls (initial notification and consult)
• Support onsite resolution of product related issues.
• Ensure compliance to data integrity (i.e. perform audit trail reviews).
• Perform trouble shooting for in process issues and escalate as needed.
• Review and provide approval for CM procedure changes.
• Write protocols for non-routine testing or validation with appropriate guidance.
• Participate on Joint Process Teams (JPT).
• Review, enter, or SPV analytical data and escalate as needed.
• Ensure batches are identified and appropriately sampled for annual stability requirements.
• Provide on-site support for GQAAC audits and Regulatory inspections.
• Review and approve complaint investigations.
• Consult on Master batch record updates; provide input based on observations and interactions on the floor.
• Metrics tracking.
• Assist in gathering data to complete the CMs Site Compliance Reports (SCR); provide review as needed.
• Perform internal notification of quality issues where needed.
• Serving as a liaison between the CM and JPT.
• Ensuring that materials and products manufactured at CMs are released in compliance with marketing authorization requirements and all applicable GMPs for the intended market.
• Participate in CM performance reviews (Ex IOPs, supply management …etc).
• Track and monitor quality metrics for trends at the CMs.

Support batch release activities by:

• Complete batch record and PPM reviews (packaging), reporting any issues.
• Determine final disposition of batches by reviewing all required documentation including but not limited to change controls and deviations.
• Originate and investigate deviations associated with batch records.
• Work with Lilly support groups to resolve product related issues.
• Create Certificates of Analysis or other similar documentation for internal and external customers as needed.
• Maintain material management (e.g. check all API restrictions in SAP and apply those restrictions to finished product).
• Provide support for Notification to Management data gathering.
• Provide input for metrics reports to management.
• Provide approval of Certificate of Analysis or other similar batch release documentation for internal and external customers.

Relationships:

• Develop and maintain strong working relationships with CM primary DPEM contacts, QA/QC personnel and shop floor personnel.

• Ensure CMs are following Quality Agreement and appropriate quality systems as part of routine operations.
• Assist QA Primary loop role with providing potential topics for GQAAC audit of the CM.
• Assist CMs on the preparation of any audit from Lilly (GQAAC) or any external agency inspection that impact Lilly products.
• Follow up on Global Quality Assurance Auditing & Compliance (GQAAC) audit findings, ensuring that the CMs is taking appropriate actions in the due time.

Continuous Improvement:

• Support continuous improvement initiatives at the CM (i.e. identify vulnerabilities and inefficiencies of the process and promote improvement projects.
• Ensure quality improvements are managed through the GMP plan process. Ensure evidence of completion and completes in a timely manner.

Basic Qualifications:

• Bachelor´s Degree in Pharmacy, Chemistry, Engineering, Biological Science or related Life Science.
• Minimum 3-5 years of experience supporting quality and/or technical functions within Device Assembly/packaging operation.

Additional Skills/ Preferences:

• Regulatory related experience.
• Established technical, quality, and internal networks.
• Experience with Lilly systems (SAP, Trackwise, Q docs…etc.).
• Previous experience supporting batch release for parenteral and/or packaging products may be preferred.
• Ability to represent Eli Lilly’s mission, policies, and practices in a positive, professional, and ethical manner and to influence CMs.
• Demonstrated ability to work independently.
• A thorough understanding of cGMPs and Global Quality Standards.
• Strong written and communication skills, especially attention to detail in written procedures and protocol development.
• High learning agility.
• Strong leadership, interpersonal and teamwork skills, able to work effectively in a cross functional team environment.
• Ability to organize, prioritize, multi-task and influence others.
• Strong decision making and problem-solving skills.
• Willingness to learn new technologies.
• Capability to work in a virtual and complex environment.
• Willingness to travel.
• Appreciation for cultural diversity.

Additional Information:

• Shift is days, but schedule flexibility and off hours may be necessary to support operations.
• Location is at the CM manufacturing site – Philadelphia, Pennsylvania.
• Some travel (~10-20%) is required primarily to Indianapolis, Indiana.