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:

Synthetic Molecule Design and Development (SMDD) is comprised of different groups that design and execute the development of all CMC aspects of synthetic molecules from pre-clinical phases through commercialization for drug substances and drug products.

Responsibilities:

Through scientific training and relevant experience, a team of scientists and team leaders support the portfolio from pre-clinical development through the commercialization of new drug candidates.  Teams of cross functional scientists will drive integration of technical elements from internal and external groups enabling the clinical manufacturing and commercialization of new drug candidates.

Understands and complies with corporate, divisional, and departmental procedures, including good manufacturing practices, safety, and other applicable regulations, and provides leadership in the establishment and maintenance of SMDD Quality systems.

Contributes to, leads and/or supervises the formulation, process development and or control strategy of drug product.  Typical responsibilities include:

Designs and develops the quality target profile for assets entering clinical development

Development of the manufacturing processes and control strategies for drug product.

Development of the manufacturing processes and control strategies for drug product leading to FHD.

Preparation of the appropriate manufacturing and controls portion of the IND/CTX and preparation of information for annual updates.

Scale-up and transfer of processes to manufacturing.

Preparation or oversight and review of the appropriate manufacturing and controls portion of regulatory submissions.

Provides advice and guidance to teams on the development of a clinical and commercial development strategy.

Authors, reviews, or approves high quality technical reports and regulatory submissions dealing with the work performed by the department.  Ensures that records and technical notebooks are adequately maintained.

Oversight of drug product material supply campaigns internally or in the third party network.

Demonstrates the TeamLilly Leadership behaviors

Plans and manages short term and long-term development activities.  Assigns work to be done, coordinates, evaluates, and reviews the activities of personnel assigned to the group.

Develops or reviews plans and timetables for project work.  Recommends the resource allocation to accomplish projects according to plans, communicates progress, and proposes changes in project timetables, objectives, or direction.

Authors, reviews, or approves high quality technical reports and regulatory submissions dealing with the work performed by the department.  Ensures that records and technical notebooks are adequately maintained.

Helps ensure that people, and their environment are safe and that company policies concerning safety are followed.

Collaborates closely with business interfaces including Discovery Chemistry, Biology, ADME, Toxicology, Product Delivery, Quality, Manufacturing and Regulatory.

Takes leadership in the supervision of the compliance of this department with the laws, regulations, guidelines, procedures, and practices governing drug research and development, including the departmental and corporate standard operating, good manufacturing, and safety procedures.

Enhances Lilly’s professional image and competitive advantage by patents, presentations, publications, and professional activities.

Reads current literature and appraises relevant new technologies and products.  Ensures that people assigned to their group continue to grow technically and professionally and encourages their efforts toward excellence.  Encourages them to share learnings by word and example.

Supervision, mentorship and technical development of the scientific staff.

Demonstrate engagement and employ a quality mindset in all endeavors by proactively identifying quality issues and communicating appropriately.

Basic Requirements

PhD in engineering or pharmaceutical science or related fields with 10+ years of drug product experience in an industry setting experience or a bachelor's or master's degree with 15+ years of drug product experience in an industry setting (Pharmaceutical, Biotech or related).

Additional Skills/Preferences

Broad, technical knowledge of areas needed for development of new pharmaceutical products.

Creativity, imagination, and ability to transform ideas into marketable products and processes.

Sufficient knowledge to effectively interact with quality control, production, process, engineering, and regulatory agencies.

Demonstrated ability to drive and accept change.

Strong technical skills to supply business value.

Knowledge and experience in project management.

Demonstrated leadership capabilities especially in a team environment. Promotes cross-functional relationship.

Good interpersonal skills and demonstrated collaborative abilities.

Demonstrated success in persuasion, influence, and negotiation skills.

Good verbal and written communication skills

Preferred experience with manufacturing / process support.

Ability to prioritize multiple activities and manage ambiguity.

Influence others to promote a positive work environment.

Demonstrated initiative and risk-taking.

Demonstrated technical proficiency and ability to identify problems/issues, develops solutions and create ideas for future work plans.

Understanding and awareness of the external scientific and regulatory landscape, effectively represents area in the external environment to apply learning, identify opportunities.

Proven human relations and supervisory skills with ability to motivate, coach and influence personnel within the department and in other associated work groups.

Additional Information

Potential exposure to chemicals, allergens and loud noises.

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%

Position Location: Lilly Technology Center North

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 (https://careers.lilly.com/us/en/workplace-accommodation) 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

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.

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