7 Jobs in Kinsale

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.
**Overview:**
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
**Outline of Role:**
Associate Director, Joint Process Team (JPT) is responsible for leading a cross functional team comprised of both Lilly and Active Pharmaceutical Ingredient (API) Contract Manufacturer representatives as part of the API External Manufacturing (API EM) site. This role is hosted at the Kinsale, Ireland site (or in LTC-N in Indianapolis, IN) and reports into the Sr. Director - External API Manufacturing Operations. The Associate Director, JPT is the key business relationship owner with the of Contract Manufacturer and is required to build & leverage relationships at all levels to ensure projects and materials are delivered on time and within downstream customer expectations. The Associate Director, JPT will partner with Lilly's Process Research & Development group on commercialization (technology transfer, process validation and regulatory approval) of Lilly's exciting leading pipeline and will be a member of the Flow Team and Extended Site Lead Team.
**Key Responsibilities:**
+ Lead cross-functional Joint Process Teams to develop and achieve strategically aligned objectives (related to safety, quality, reliable supply and technology transfer) at the Contract Manufacturer
+ Lead internal process teams (IPTs) to enable successful completion of joint Lilly- Contract Manufacturer objectives
+ Successfully facilitate and champion quality, technical, and regulatory compliance at the Contract Manufacturer
+ Oversee production, batch release and shipment/supply chain schedules to ensure reliable supply
+ Facilitate Joint Steering Committee (JSC) meeting agendas with significant issues escalating from the JPT and strategic topics that require alignment from both Lilly and the Contract Manufacturer
+ Accountable for Contract Manufacturer performance metrics in line with Lilly's Global Contract Manufacturing Standards
+ Liaise with senior management levels in Manufacturing, Quality, Development and commercial Business Units as required
+ Make regular visits to Contract Manufacturers to increase awareness of operations and maintain working relationships
+ Partner with Global Procurement and Manufacturing Strategy on due diligence and sourcing activities
Key Attributes:
+ **Business Knowledge:** Relevant experience in the business and demonstrated performance in delivery. Looks at better, simpler ways, takes initiative and will run proactively with actions. Demonstrated self-management, prioritisation and organisational skills.
+ **Learning Agility and Curiosity:** High learning agility and flexibility, and ability to deal with ambiguity and uncertainty. Demonstrated ability to identify and prioritize problems, develop and implement solutions.
+ **Positive Influence:** Demonstrated ability to address issues as they arise and take action in a positive collaborative manner. Trusted in the team to follow through on actions. Is interested in own performance and seeks feedback to improve.
+ **Relationship Builder:** Demonstrated ability to establish and maintain relationships across all levels in the organisation and externally. Demonstrated ability to listen and understand individual perspectives.
+ **Ability to Lead People:** Demonstrated ability to lead and motivate in a team environment and a strong interest and passion for leading people. Demonstrated ability to influence peers and across functions.
+ **Communication:** Demonstrated strong communication skills, written and oral in 1:1 and group situations.
+ **Decision Making:** Demonstrated ability to be decisive and make well informed decisions for the benefit of the team. Demonstrated ability to collate required information and ask the appropriate questions of peers to get to the best solution.
**Basic Requirements:**
+ Minimum Bachelor's Degree in a scientific or engineering discipline
+ 5+ Years of API Manufacturing experience supporting API production operations and/or technology transfer
**Additional skills/preferences:**
+ 2+ years of demonstrated leadership and/or mentorship experience is strongly desirable
+ Ability to externally represent Lilly in a positive, professional and ethical manner
**This position is located onsite in Indianapolis, IN or Kinsale, IE and is not approved for remote work.**
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$122,250 - $179,300
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).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.
#WeAreLilly

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.
**Purpose:**
Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Clinical Research Scientist - Clinical Development: Neuropsychologist is an integral member of the Neuroscience medical development team and participates in: the development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of the product; the implementation of global clinical trials; the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for the product; and various medical activities in support of demand realization.
The Clinical Research Scientist must be aware of and ensure that all their activities are in compliance with current local and international regulations, laws, guidance's (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 medical vision.
**Overall Responsibilities** **:**
With the expansion of the Lilly portfolio, this role will be responsible for scientific support for clinical trials across the Neuroscience platform and serves a spectrum of patients with neurological and psychiatric conditions. The clinical research scientist is a scientific resource for study teams, departments, and others as needed, particularly pertaining to the selection of clinical trial endpoints, the implementation and central monitoring strategy of clinical endpoints and the translation of clinical trial outcome data into meaningful benefits. This includes, but is not limited to, design and execution of phase 2/3 studies to address the needs of the commercial organization.
The ideal candidate will be a critical thinker and understand Neuroscience, Neuropsychology, neuropsychological assessment and measurement science.
**Specific responsibilities may include but are not limited to:**
**Clinical Planning**
+ Collaborate with the business unit geographical regions, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, and payer); the product lifecycle plan, clinical strategies, development plans and study protocol design.
+ Contribute to business unit and global alignment of clinical strategy and clinical plans.
+ Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
**Clinical Research/Trial/ Execution and Support**
+ Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (e.g., annual reports) according to the agreed upon project timeline.
+ Provide protocol oversight and input into informed consent documents.
+ Supports the monitoring of patient safety during study and participates in the global product safety reviews including the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.
+ Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions).
+ Review and collaborates with CRP on the approval of risk profiles to ensure appropriate communication of risk to study subjects.
+ Participate in investigator identification and selection, in conjunction with clinical teams.
+ Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
+ Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
+ Serve as resource to clinical operations/CTMs/ clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
+ Understand and actively address the scientific information needs of all investigators and personnel.
+ Review lIT proposals and publications, as requested by CRP or Director-Medical.
**Scientific Data Dissemination/Exchange**
+ Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals.
+ Understand and address the unsolicited scientific information needs of external health care professionals according to guidelines above.
+ Participate in reporting of clinical trial data in Clinical Trial Registry activities.
+ Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
+ Prepare or review scientific information in response to customer questions or media requests
+ Provide telephone follow-up or specific written information requested by health care professionals as per global SOPs.
+ Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a local, national, regional and possibly international basis.
+ Support the design of customer research as medical expert
+ Support medical information associates in preparation and review of medical letters and other medical information materials.
+ Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts).
+ Develop and maintain appropriate collaborations and relationships with relevant professional societies.
+ Support training of medical personnel, including geographic/affiliate medical personnel as assigned, medical and outcome liaisons and global patient outcomes personnel.
+ Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events)
+ Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.
**Regulatory Support Activities**
+ Participate in development and review of label changes and labeling modifications in collaboration with affiliates, brand teams, regulatory, and legal.
+ Provide medical expertise to regulatory scientists.
+ Support/assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective.
+ Participate in advisory committees.
+ Participate in risk management planning along with affiliates and Global Patient Safety (GPS).
**Scientific I Technical Expertise and continued development**
+ Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product
+ Responsible for the scientific training of the clinical study team.
+ Acts as scientific consultant and protocol expert for clinical study team members and others in medical.
+ Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near term (1-2 years) and longer term (3-5 years).
+ Explore and take advantage of opportunities for extramural scientific experiences
+ Attend, contribute and participate in scientific symposia, as well as administrative/business workshops and training.
**General Responsibilities**
+ Actively set and meet individual professional development goals and contribute to the development of others.
+ Support the management team, including the Sr. Director-Medical, in preparation and administration of the business unit development budget.
+ Actively participate in recruitment, diversity and retention efforts.
+ Collaborate proactively and productively with all alliance, business and vendor partners.
+ Participate in active coaching by providing timely and constructive feedback to co-workers, others on the medical team, in the spirit of development, increased team effectiveness and cohesiveness.
+ Participate in committees, process improvement initiatives and task forces as requested by local/corporate management
+ Ensures that at all times is adequately qualified and trained in the tasks required to perform. Includes accountability and compliance for maintaining a current curriculum training map for self.
+ Model the leadership behaviors
+ Be an ambassador of both patients and the Lilly Brand
**Basic Requirements:**
+ Doctoral level Degree (Ph.D, Psy.D or equivalent) in Clinical Neuropsychology with 2+ years industry or academic experience beyond any postdoctoral positions.
+ Demonstrated experience in clinical and/or research settings in working with adults with neurological and/or psychiatric disorders
+ Clinical experience in conducting assessments and administering standardized scales within a clinical and/or research context.
+ Experience and agility in the conduct and interpretation of statistical and psychometric analyses
+ Evidence of scientific track record in publications, conference presentations
**Additional Information:**
+ Fluent in English, written and verbal communications
+ Ability to engage in occasional domestic and international travel to the degree appropriate to support the business of the team.
+ Position Location - Indianapolis, IN or Remote
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$142,500 - $228,800
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).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.
#WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
**Organization Overview:**
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism
**Position Summary:**
The Senior Director of TSMS - Tech Transfer is a strategic leadership role within the central TSMS organization, responsible for leading global technical teams in the successful transfer of drug substance and dry oral products (including SDD) processes across internal and external manufacturing sites. This role ensures consistent execution of Lilly's commercialization strategy, drives technical excellence, and fosters collaboration across development, manufacturing, and regulatory functions.
**Key Responsibilities:**
**Tech Transfer Leadership**
+ Lead organization of TSMS technical experts on global tech transfer teams supporting both the initial commercialization of pipeline products and node to node transfers of commercial products across the drug substance and dry products portfolio.
+ Responsible for the development of standardized business processes and Playbooks to support global tech transfers across multiple platforms and multiple sites (including simultaneous transfers to dual sourcing sites).
+ Ensure alignment of Playbooks with Single Process Map deliverables and ensure buy-in from BR&D/SMDD and Analytical (AQCL) on generation of standardized business processes.
+ Ensure the team is appropriately structured to own and continuously improve Tech Transfer Playbooks and associated training programs.
+ Ensure consistency in technical deliverables and documentation across transfers.
**Strategic & Portfolio Management**
+ Partner with CMC PMs and development teams to guide tech transfer execution using Lilly's Single Process Map.
+ Co-own commercialization playbooks with Commercialization and Molecule Stewards.
+ Ensure adequate staffing and capability of tech transfer teams.
+ Provide escalation and troubleshooting support for complex tech transfer challenges.
**Organizational Leadership**
+ Represent TSMS at governance bodies and technical network meetings.
+ Build relationships and influence across manufacturing sites and central functions.
+ Lead performance management, talent development, and succession planning.
+ Mentor and coach project managers and technical leaders in commercialization and tech transfer.
**Qualifications:**
**Education**
+ Minimum: B.S. in Chemistry, Pharmacy, Engineering, or related scientific discipline.
+ Preferred: Master's or Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or Microbiology.
**Experience**
+ 15+ years in pharmaceutical manufacturing or technical services within a cGMP environment.
+ 5+ years of experience in drug substance or dry product tech transfer and commercialization.
+ Proven leadership in cross-functional teams and successful molecule transfers.
+ Deep technical knowledge of parenteral products and control strategies.
**Skills & Competencies**
+ Strong project management and strategic planning skills.
+ Excellent communication and stakeholder engagement.
+ Ability to influence across sites and central functions.
+ Experience mentoring and developing technical talent.
**Additional Information:**
Some domestic and international travel may be required.
This role is part of the TSMS leadership team and contributes to long-term business planning and organizational capability development.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $244,200
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).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.
#WeAreLilly

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.
**Position Summary**
The Senior Director of TSMS - Technical Agenda is a strategic leadership role within the central TSMS organization, responsible for shaping and delivering the technical agenda across the Drug Substance and Dry Product portfolio. This role will drive a focused effort on delivering critical technical agenda projects and initiatives at a product basis through a team of Associate Directors responsible for laboratories and Pilot Plants across the platforms of biologics and synthetic products. The Senior Director will lead technical experts, drive innovation and technical excellence, and ensure alignment with Lilly's commercialization strategy, manufacturing productivity agenda and evolving API/Dry Network needs.
**Key Responsibilities**
**Strategic Leadership & Technical Direction**
+ Drive generation of technical agenda for products/processes with PR&D minimally on a biannual basis (Strategic Plan and Business Plan) through purposeful workshops to ensure active hopper of projects and initiatives.
+ From collaborative workshops, define the technical agenda for drug substance and dry products, including Spray Dry Dispersion/DP intermediates, and other innovation platforms.
+ Using prioritization tools, present and gain alignment on the technical agenda priority project through the ADN -LT, utilizing the Commercialization Lead Team as the decision forum.
+ Lead strategic planning for development and execution of tertiary loop/technical agenda projects and significant and impactful process optimization projects.
+ Use internal lab and Pilot Plant resources to deliver initial proof of concept (PoC) studies to support direction of tech agenda. Maximize internal resourcing, and where necessary use external capability/capacity to achieve full development package (process definition and data) to point of readiness for technology transfer to commercial sites. Where necessary, de-risk tech transfer and PV of the optimized process, by orchestrating Pilot scale batches.
+ Drive the completion of technology transfer package for implementation of the tech agenda at the manufacturing sites.
**Organizational Leadership**
+ Lead a global team of Associate Directors (responsible for scientists/specialists/ operators) and technical experts supporting execution of technical agenda across drug substance, dry product and drug product intermediates.
+ Build and maintain strong technical relationships at a Senior Director level with BR&D, SMDD, and manufacturing sites.
+ Work closely with Molecule Stewards, Product Leads in developing and delivering technical agenda across products.
+ Serve as the initial point of escalation for technical issues across the lab/Pilot Plant programs.
+ Drive performance management, talent development, and succession planning.
+ Foster a culture of innovation, collaboration, and continuous improvement.
+ Represent TSMS at governance bodies and technical network meetings.
**Change Management & Transformation**
+ Support organizational redesign efforts to align with Lilly's centralization strategy.
+ In consultation with TSMS AVP - Synthesis/TIDES, and AVP - Biologics, and in collaboration with Fellows team, support the setting up of appropriate teams responsible for Tech Agenda development and and execution.
+ Lead integration of impacted teams into the central TSMS structure.
+ Communicate effectively during transitions, ensuring clarity and support for affected employees.
**Qualifications**
**Education**
Minimum: BSc in a science, engineering, or technical field.
Preferred: MSc or Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemistry, Chemical Engineering, or Microbiology.
**Experience**
+ 10+ years in pharmaceutical manufacturing or technical services within a cGMP environment.
+ Proven leadership in managing technical teams and delivering strategic initiatives.
+ Experience in drug substance development, dry product formulation and regulatory support.
**Skills & Competencies**
+ Strong strategic thinking and decision-making capabilities.
+ Excellent communication and stakeholder management skills.
+ Deep technical expertise in drug substance manufacturing and commercialization.
+ Ability to lead through change and build high-performing teams.
**Additional Information**
This role may require occasional travel to Lilly sites, external partners, or industry conferences.
The position is part of the TSMS leadership team and contributes to long-term business planning and organizational capability development.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $222,200
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).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.
#WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
**Organization Overview**
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
**Responsibilities:**
The Associate Director - API EM Engineering Leader for Peptides and Large Molecule is a member of the API EM Plant Lead Teams providing leadership and expertise to reliably supply and commercialize externally manufactured APIs, intermediates and starting materials with safety first and quality always. The role reflects increasing technical complexity and commercialization activity associated with API EM operations as the pipeline portfolio progresses.
**Engineering/HSE**
+ Provide API EM organizational Engineering leadership for Peptides and Large Molecule as a member of the APIEM Plant Lead Team, HSE Lead Team, Science Lead Team, and co-lead the Engineering Lead Team
+ Coach and mentor engineering associates in aspects of fundamental engineering support, including process knowledge, problem solving and engineering design
+ Provide administrative oversight and support to a team of process engineers across multiple geographies
+ Develop and provide ongoing leadership for a PSM program within API EM with the goal of improving PSM capabilities and performance at CMs
+ Responsible for ensuring assessments of the HSE and PSM capabilities of each CM impacting Lilly products are completed during the sourcing process and maintained during the product lifecycle at a CM
+ Responsible for ensuring FUME assessments of CMs to understand risks presented to Lilly products control strategy are completed and maintained
+ Lead Lilly internal resources (API EM, ETC, others as required) and partner with CM (Contract Manufacturer) resources in the execution of HSE, PSM and FUME capability assessments of CMs
+ Lead internal resources and partner with CMs through specification, procurement, and IQ/OQ/PQ of equipment to ensure capital projects at CMs are delivered on time, within budget and meeting technical expectations
+ Adherence to the expectations of the Lilly Red Book when carrying out interactions with API EM's CMs.
**Basic Requirements:**
+ Bachelor of Science degree in Chemical Engineering, or another engineering discipline with extensive pharmaceutical manufacturing experience.
+ 7+ years of work experience in a manufacturing operations and process engineering related roles
**Additional Preferences:**
+ Demonstrated ability to apply fundamental chemical engineering principles to process understanding, problem solving, and process improvement.
+ Demonstrated ability to manage capital delivery project or commercialization / technical agenda projects
+ Deep technical knowledge of bulk API manufacturing equipment and unit operations.
+ Demonstrated ability to understand and influence integration points with other business areas, processes, and functions.
+ Direct or indirect experience with commercialization (Validation, Tech Transfer, CMC, GMP, Quality, and/or HSE)
+ Demonstrated ability to function in a team environment as a leader and as a member of teams.
+ Demonstrated ability to manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audiences.
+ Experience in typical unit operations for large molecule expression and purification and small molecule manufacture
+ Process Hazard Analysis experience
+ Project management qualifications or demonstrated ability to develop detailed project plans including critical path and risk register analysis
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$118,500 - $173,800
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).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.
#WeAreLilly