Manufacturing Scientist – API Manufacturing Process Support
We’re looking for people who are determined to make life better for people around the world.
Organization Overview :
The Manufacturing Scientist provides the technical support required to achieve the reliable and compliant manufacture of the Active Pharmaceutical Ingredient External Manufacturing (API EM) portfolio which includes raw materials, intermediates, enzymes and bulk drug substances.
The API EM ManufacturingScientist executes technical projects (experimental, modeling and / or production data analysis) to improve and optimize process control, yield, purity, and / or productivity.
In addition, the manufacturing scientist should be capable and technically independent in setting up and executing a variety of experiments at the laboratory scale and conduct research on manufactured product for process improvements and troubleshooting in the technical services and manufacturing sciences laboratory.
Responsibilities :
- Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment.
- Execute technical projects (experimental, modeling and / or production data analysis) to improve process control, yield, purity, and / or productivity.
- Provide technical support for preparation of relevant technical documents, as required, such as : technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs (Process Flow Documents), VMPs, etc.
- Develop and monitor established metrics in real-time to assess process variability and capability.
- Understand, justify and document the state of validation (process and cleaning) with data that evaluate the capability of the manufacturing process to meet its stated purpose.
- Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
- Provide support internal and joint process teams and to the global and local PLOT teams.
- Ability to independently set up and execute various chemical reactions.
- Ensure that experiments are well designed with clear objectives.
- Ability to analyze data and ensure appropriate documentation.
- Utilize save laboratory practice and adhere to CHP requirements.
- Write technical reports and documents.
Basic Requirements :
- Bachelors in STEM Discipline (Chemistry focus preferred) and at least 3 years of experience in cGMP manufacturing.
- Master's Degree and 1 year experience in cGMP manufacturing.
Additional Preferences :
- Relevant industrial experience in any of the following discipline such as API Manufacturing, TS / MS (Technical Services / Manufacturing Sciences), Quality Control, Quality Assurance, or Development.
- Demonstrated basic knowledge in small or large molecule API Manufacturing.
- Familiarity with cGMP manufacturing environment and terminology.
- Excellent analytical, interpersonal, written and oral communication skills.
- Ability to work independently as well as part of a team.
- Ability to prioritize activities.
- Good judgment and flexibility.
Additional Information :
- Tasks require entering manufacturing areas which require wearing appropriate PPE.
- Domestic and international Travel (variable, can approach 20%).
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.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles.
Our current groups include : Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities.
Learn more about all of our groups.
WeAreLilly
Pharmaceutical Sales - Alzheimer's Disease Consultant
We’re looking for people who are determined to make life better for people around the world.
Position Territory - MOUNT VERNON NY ADC 161852
Lilly's ongoing research and commercial efforts in Alzheimer’s Disease (AD) present one of the most exciting opportunities in the history of the company.
There is currently a significant, growing, and intense unmet need across all key players. AD is the sixth leading cause of death in the US, and of the top 10 causes of death, it is the only disease with an increasing mortality rate and the only one that cannot be prevented, cured, or even slowed.
Lilly’s goal is to make the dementia associated with the disease preventable. We are uniquely positioned to achieve this goal : following 30+ years of investment in AD research and development across both therapeutics and diagnostics, Lilly recently announced top-line results for the positive Phase 3 trial of a beta-amyloid plaque clearing therapy, which demonstrated a significant slowing of decline in a composite measure of cognition and daily function in patients with early symptomatic AD.
With this ground-breaking positive data and the possibility of launch after receiving FDA Breakthrough Therapy designation, Lilly can address this significant unmet need by launching a potential best-in-class AD therapy in tandem with an arsenal of AD diagnostics that support the timely and accurate identification of patients who may benefit from the therapy.
Advanced diagnostics to confirm Alzheimer’s disease pathology are becoming an increasingly critical component of the diagnostic pathway to identify those patients most likely to benefit from therapy.
Lilly launched the first PET amyloid imaging agent to identify evidence of amyloid pathology in the brains of living patients, in the United States in 2012.
In 2020 the first PET tau imaging agent, was approved by the FDA
The combined AD diagnostic and therapeutic ecosystem (referral dynamics, comprehensive diagnostics, treatments, and care management) must be further developed for patients to be diagnosed and treated efficiently and effectively, to support positive customer and patient experiences.
This position will be instrumental in supporting the development of the US AD ecosystem, most significantly as it relates to the utilization of and experience associated with our Alzheimer’s diagnostic portfolio.
Position Description
A variety of elements need to work effectively and in harmony for patients, information, and product to flow smoothly through the process of detecting, diagnosing, and treating people with Alzheimer’s disease.
There are multiple steps, stakeholders, and physical locations involved. These interconnected ecosystems (referral dynamics, advanced diagnostics, treatments, and care management), which vary greatly by geography and health system, must be further developed to support overall patient care, so we can facilitate the desired customer experience.
The Alzheimer’s Disease Consultant (ADC) is an HCP account specialist who will be instrumental in segmenting, developing, and supporting local healthcare ecosystems, most significantly as it relates to improving the understanding of AD pathology and utilization of Lilly’s AD portfolio.
The ADC will educate and support a diverse range of customers and care sites, such as memory care centers / Centers of Excellence, imaging centers, Neurologists, Primary Care Physicians, nursing and pharmacy staff, and key office personnel.
This individual will also compliantly work across internal functions, including Medical Affairs, Medical Diagnostics, Market Managers, and Field Reimbursement teams, as well as with external partners, such as PETNET.
Given this complex environment, the need to influence systems of care and identify referral networks these sales professionals will need significant experience in account-based selling and / or working through ambiguity.
Key Deliverables
- Help build a healthy Alzheimer’s disease care ecosystem by identifying and influencing -formal and informal referral networks across different stakeholders and health systems to ensure site readiness
- Engage with customers and key office staff by utilizing value-based selling and strategic account management and by leveraging various channels, including personal (e.
g., in-person, virtual interactions) and non-personal (e.g., digital, email, etc.)
- Successfully leverage disease state education to drive awareness and buy-in on the role Alzheimer’s disease biomarkers play in AD pathology
- Support positive imaging experiences by ensuring all stakeholders are trained and equipped to scan, read, interpret, report results
- Serve as a peer leader among overlapping field partners to enable a coordinated effort ensuring each customer has a consistent, positive experience
Job Responsibilities Include
- Create exceptional customer and patient experiences by building strong partnerships across a myriad of customers in multiple care settings
- Develop a strong understanding of customer / practice dynamics, priorities, stakeholders, and goals for the brand target patient
- Develop a strong working partnership with PETNET Radiopharmacy Territory Managers to build market-level business plans and to ensure imaging center and dementia specialist needs are met
- Welcome innovative thinking, differing perspectives, and external information
- Demonstrate Lilly values and TEAM LILLY behaviors, positively influencing team culture
- Collaborate effectively and compliantly with internal cross-functional partners and across the district team
Innovate
- Earn a reputation as a subject-matter expert and valued resource both internally and externally
- Engage with world-leading key thought leaders and clinical experts
- Develop compliant and innovative ways to influence the local AD ecosystem to ensure patients, information, and product flow smoothly from diagnosis to treatment and follow up
- As the external environment evolves, anticipate, embrace, and adapt to change
- Test, learn, and iterate new ways of approaching customers and building a sustainable infrastructure to support the Alzheimer’s disease care ecosystem
Accelerate and Deliver
- Create awareness and discuss the importance of key Alzheimer’s disease biomarkers by providing disease state education to customers
- Promote product portfolio as appropriate, to facilitate an effective and timely detection / diagnostic process
- Educate customers on the target patient, efficacy, safety, and overall treatment experience
- Leverage Strategic Account Management skills to understand patient, product, and monetary flows when a patient is referred for advanced AD diagnostic testing or an infusion
- Develop, execute, and continuously evaluate and adjust account / territory plans with business partners
- Determine needs, expectations, and pain points for HCPs, patients, and care settings in local territory
- Solve problems and address challenges for HCPs when referring a patient for a PET scan or an infusion
Basic Qualifications
- Bachelor’s degree
- At least three years of experience in a field facing role or three years of relevant experience
- Valid driver’s license and acceptable driving record is required
- Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.
g., H-1B or TN status) for this employment position.
Additional Preferences
- Strong performance in prior account-based sales experience (e.g., oncology, hospital / institution, medical device, buy and bill and / or medical benefit products)
- Customer continuity is strongly preferred, as applicable
- MBA, relevant advanced degree (e.g., Pharmacy, RN, MPH, etc.), or certification (e.g., PET / CT technologist)
- HCP marketing experience in the biotech / healthcare industry
- Alzheimer’s disease, Diagnostics, Neuroscience / Neurology, or related experience
- Clinical background in Alzheimer’s Disease or the diagnostics space
- Live inside geography or within 30 miles of geography boundaries
- Experience in a fast paced and dynamic environment with an ability to synthesize the complex and to create and execute effective action plans.
- Strong business analytics and strategic thinking skills with the ability to navigate ambiguity
- Proven ability to work well cross functionally and collaboratively.
- Exemplary ability to demonstrate resilience, grit, and appropriately self-resolve problems.
- Proven track record of success
- Self-starter who works with minimal direction
- Innovative thinker
- Curiosity to thrive in white space
- Displays resilience and tenacity necessary to overcome challenges
- Ability to comprehend and explain complex clinical studies
- Ability to comprehend, utilize, and communicate technical information
Additional Information
Lilly is an EEO / Affirmative Action Employer and does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.
Lilly currently anticipates that the base salary for this position could range from between $112,500-209,000 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience.
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k);
pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.
g., healthcare and / or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits;
and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Of course, the compensation described above is subject to change and could be higher or lower than the range described above.
Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles.
Our current groups include : Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities.
Learn more about all of our groups.
WeAreLilly
Pharmaceutical Sales - Alzheimer's Disease Consultant
We’re looking for people who are determined to make life better for people around the world.
DALLAS TX ADC 161817
Lilly's ongoing research and commercial efforts in Alzheimer’s Disease (AD) present one of the most exciting opportunities in the history of the company.
There is currently a significant, growing, and intense unmet need across all key players. AD is the sixth leading cause of death in the US, and of the top 10 causes of death, it is the only disease with an increasing mortality rate and the only one that cannot be prevented, cured, or even slowed.
Lilly’s goal is to make the dementia associated with the disease preventable. We are uniquely positioned to achieve this goal : following 30+ years of investment in AD research and development across both therapeutics and diagnostics, Lilly recently announced top-line results for the positive Phase 3 trial of a beta-amyloid plaque clearing therapy, which demonstrated a significant slowing of decline in a composite measure of cognition and daily function in patients with early symptomatic AD.
With this ground-breaking positive data and the possibility of launch after receiving FDA Breakthrough Therapy designation, Lilly can address this significant unmet need by launching a potential best-in-class AD therapy in tandem with an arsenal of AD diagnostics that support the timely and accurate identification of patients who may benefit from the therapy.
Advanced diagnostics to confirm Alzheimer’s disease pathology are becoming an increasingly critical component of the diagnostic pathway to identify those patients most likely to benefit from therapy.
Lilly launched the first PET amyloid imaging agent to identify evidence of amyloid pathology in the brains of living patients, in the United States in 2012.
In 2020 the first PET tau imaging agent, was approved by the FDA
The combined AD diagnostic and therapeutic ecosystem (referral dynamics, comprehensive diagnostics, treatments, and care management) must be further developed for patients to be diagnosed and treated efficiently and effectively, to support positive customer and patient experiences.
This position will be instrumental in supporting the development of the US AD ecosystem, most significantly as it relates to the utilization of and experience associated with our Alzheimer’s diagnostic and therapeutic (pending FDA approval) portfolio.
Position Description
A variety of elements need to work effectively and in harmony for patients, information, and product to flow smoothly through the process of detecting, diagnosing, and treating people with Alzheimer’s disease.
There are multiple steps, stakeholders, and physical locations involved. These interconnected ecosystems (referral dynamics, advanced diagnostics, treatments, and care management), which vary greatly by geography and health system, must be further developed to support overall patient care, so we can facilitate the desired customer experience.
The Alzheimer’s Disease Consultant (ADC) is an HCP account specialist who will be instrumental in segmenting, developing, and supporting local healthcare ecosystems, most significantly as it relates to improving the understanding of AD pathology and utilization of Lilly’s AD portfolio.
The ADC will educate and support a diverse range of customers and care sites, such as memory care centers / Centers of Excellence, imaging centers, Neurologists, Primary Care Physicians, nursing and pharmacy staff, and key office personnel.
This individual will also compliantly work across internal functions, including Medical Affairs, Medical Diagnostics, Market Managers, and Field Reimbursement teams, as well as with external partners, such as PETNET.
Given this complex environment, the need to influence systems of care and identify referral networks these sales professionals will need significant experience in account-based selling and / or working through ambiguity.
Key Deliverables
- Help build a healthy Alzheimer’s disease care ecosystem by identifying and influencing -formal and informal referral networks across different stakeholders and health systems to ensure site readiness
- Engage with customers and key office staff by utilizing value-based selling and strategic account management and by leveraging various channels, including personal (e.
g., in-person, virtual interactions) and non-personal (e.g., digital, email, etc.)
- Successfully leverage disease state education to drive awareness and buy-in on the role Alzheimer’s disease biomarkers play in AD pathology
- Support positive imaging experiences by ensuring all stakeholders are trained and equipped to scan, read, interpret, report results
- Serve as a peer leader among overlapping field partners to enable a coordinated effort ensuring each customer has a consistent, positive experience
Job Responsibilities Include
- Create exceptional customer and patient experiences by building strong partnerships across a myriad of customers in multiple care settings
- Develop a strong understanding of customer / practice dynamics, priorities, stakeholders, and goals for the brand target patient
- Develop a strong working partnership with PETNET Radiopharmacy Territory Managers to build market-level business plans and to ensure imaging center and dementia specialist needs are met
- Welcome innovative thinking, differing perspectives, and external information
- Demonstrate Lilly values and TEAM LILLY behaviors, positively influencing team culture
- Collaborate effectively and compliantly with internal cross-functional partners and across the district team
Innovate
- Earn a reputation as a subject-matter expert and valued resource both internally and externally
- Engage with world-leading key thought leaders and clinical experts
- Develop compliant and innovative ways to influence the local AD ecosystem to ensure patients, information, and product flow smoothly from diagnosis to treatment and follow up
- As the external environment evolves, anticipate, embrace, and adapt to change
- Test, learn, and iterate new ways of approaching customers and building a sustainable infrastructure to support the Alzheimer’s disease care ecosystem
Accelerate and Deliver
- Create awareness and discuss the importance of key Alzheimer’s disease biomarkers by providing disease state education to customers
- Promote product portfolio as appropriate, to facilitate an effective and timely detection / diagnostic process
- Educate customers on the target patient, efficacy, safety, and overall treatment experience
- Leverage Strategic Account Management skills to understand patient, product, and monetary flows when a patient is referred for advanced AD diagnostic testing or an infusion
- Develop, execute, and continuously evaluate and adjust account / territory plans with business partners
- Determine needs, expectations, and pain points for HCPs, patients, and care settings in local territory
- Solve problems and address challenges for HCPs when referring a patient for a PET scan or an infusion
Basic Qualifications
- Bachelor’s degree
- At least three years of experience in a field facing role or three years of relevant experience
- Valid driver’s license and acceptable driving record is required
Additional Preferences
- Strong performance in prior account-based sales experience (e.g., oncology, hospital / institution, medical device, buy and bill and / or medical benefit products)
- Customer continuity is strongly preferred, as applicable
- MBA, relevant advanced degree (e.g., Pharmacy, RN, MPH, etc.), or certification (e.g., PET / CT technologist)
- HCP marketing experience in the biotech / healthcare industry
- Alzheimer’s disease, Diagnostics, Neuroscience / Neurology, or related experience
- Clinical background in Alzheimer’s Disease or the diagnostics space
- Live inside geography or within 30 miles of geography boundaries
- Experience in a fast paced and dynamic environment with an ability to synthesize the complex and to create and execute effective action plans.
- Strong business analytics and strategic thinking skills with the ability to navigate ambiguity
- Proven ability to work well cross functionally and collaboratively.
- Exemplary ability to demonstrate resilience, grit, and appropriately self-resolve problems.
- Proven track record of success
- Self-starter who works with minimal direction
- Innovative thinker
- Curiosity to thrive in white space
- Displays resilience and tenacity necessary to overcome challenges
- Ability to comprehend and explain complex clinical studies
- Ability to comprehend, utilize, and communicate technical information
Additional Information
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.
g., H-1B or TN status) for this employment position.
Lilly is an EEO / Affirmative Action Employer and does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.
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.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles.
Our current groups include : Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities.
Learn more about all of our groups.
WeAreLilly
Manufacturing Logistics
We’re looking for people who are determined to make life better for people around the world.
Position Overview :
Manufacturing Logistics is defined as the storing, transfer, and systems necessary for the effective management of materials (product / components / raws) for production into, within, and between mfg (Lilly, external, supply chain nodes) sites.
This role will join the Manufacturing Logistics team members to work across the manufacturing sites to improve the overall management of materials.
The material operational and business processes can be different across the network which impacts the site efficiency as product moves from node to node.
Over the years, the systems necessary to manage materials has been customized to accommodate the different processes. More products and components are now required to move across the network to achieve capacity and production requirements thus driving the need for harmonization and optimization.
Optimizing Manufacturing Logistics will require thorough investigation of current state processes, possible future state processes and the intended / unintended impacts of any change.
Strong interpersonal and prioritization skills will be necessary as the scope is quite broad. This position will need to isolate highly inefficient processes and work across functions / sites to determine options for paths.
The options will require networking and strategic alignment at an operational and quality level.
The use and distribution of the warehouse space, planning processes, alignment and projection of the storage required for the inventory levels defined for each type of material and thus the projection of warehouse capacity and the integration with the different elements of the process will be a key focus area for this role.
This position will need to understand the role of automation and connected systems. As the plants continue their automation strategy, the harmonization of processes becomes an enabler to achieving a common platform.
The equipment (both installed and future) impact will also be a large consideration to drive efficiency. Operating within domestic guidelines and standards (pallet size, local equipment support, etc) will also impact the possible solutions.
This position will work with a cross-functional, global team to identify opportunities, develop a strategic roadmap, and gain alignment with site / network management.
This role may facilitate some global process redesigns directly and / or coordinate several projects aimed to streamline material management throughout manufacturing networks.
High-Level Responsibilities :
- Develop and facilitate cross functional team established to improve manufacturing logistics
- Establish manufacturing logistics charter that leverages existing site / functional activities but elevates the coordination to a network / global level
- Document and prioritize current state of manufacturing logistics inefficiencies (may require external consultant)
- Drive standardization for manufacturing logistics, including processes and technology
- Support on-going EWM, TMS system implementations, as required to achieve streamlined manufacturing logistics
- Provide subject matter expertise and play a coordination role on materials management processes
- Develop multi-year roadmap that incorporates manufacturing warehouse (capacity / operational), materials movement (inter / intra), and systems (internal / external)
- Support the execution of SCM-SOP-GSC-00006, External Warehousing SOP, that defines the business requirements and standard process operations related to the approval and management activities of an external (non-Lilly managed) warehouse that is contracted by Lilly to store drug product and associated materials until distribution.
Basic Qualifications
- Bachelor's in Supply Chain or related field
- 5+ years of strong Materials Movement business process knowledge, including global process exposure. Preference for API warehousing and material movement to supplement existing team experience.
Additional Preferences :
- Knowledge of systems required to store, manage and control materials through the manufacturing process including inbound, production and outbound operations.
- Automation and / or robotics experience desired
- Knowledge of systems required to store, manage and control materials through the manufacturing process including inbound, production and outbound operations.
- Automation and / or robotics experience desired
- Excellent English written and oral communication skills.
- Strong interpersonal and communication skills.
- Good problem-solving and influencing skills.
- Ability to adapt quickly to complex circumstances and situations, learn while doing, and navigate through an ambiguous situation or issue quickly.
- Ability to influence and steer people at all levels.
- Highly motivated and independent individual with a strong desire to make a positive impact to the Lilly’s business processes.
Additional Information
- Some travel (mostly international) may be required
- Due to the nature of the support activities, some overtime and / or off hours effort may be required during peak business times.
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.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles.
Our current groups include : Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities.
Learn more about all of our groups.
WeAreLilly