Lilly Engineering Advisor in Indianapolis, Indiana
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
At Lilly, Synthetic Molecule Design and Development (SMDD) is involved in key activities for the development of synthetic active pharmaceutical ingredients and drug products from pre-clinical phases through commercialization. Our scientists and engineers develop key technical and business solutions across the portfolio using their deep technical expertise to accelerate testing of the clinical hypothesis and overall drug development. SMDD delivers on these responsibilities by recognizing diverse talent and cultures are necessary to bring the next generation of life changing medicines to patients.
Our team is looking for candidates interested in further advancing manufacturing platform technologies and commercialization of solid drug products. The candidate will collaborate with other development scientists/engineers and manufacturing groups to provide technical leadership in the design and implementation of manufacturing technology platforms, with special focus on continuous manufacturing. The position presents an opportunity to work across multiple fields, sites and networks. Top candidates for this position will be expected to:
Possess experience and deep technical expertise in both batch and continuous solid drug product manufacturing unit operations including but not limited to powder feeding, powder mixing, wet and dry granulation techniques, encapsulation, tablet compaction, and tablet film coating.
Understand the interaction of raw material physicochemical properties and processability as well as how transformative unit operations can be used to improve manufacturability.
Develop comprehensive material and manufacturing process risk assessments that will be leveraged to guide development and experimental workplans.
Define drug product critical quality attributes (CQAs) and assess the impact of raw material and process parameter changes on the CQAs.
Drive the implementation of new platforms such as continuous drug product manufacturing, process analytical technologies (PAT), and modeling and simulation tools.
Design robust and globally acceptable manufacturing process control strategies as well as partner with manufacturing colleagues to transfer and implement those control strategies.
Plan and manage short term and long-term development activities including development of technical agendas, timelines and recommend resource allocation to accomplish projects goals, according to plans. Communicate progress and propose changes.
Collaborate closely with multi-functional organizations such as Product Delivery, Project Management, Quality, Manufacturing, and Regulatory to execute and deliver material and information for clinical trials and regulatory submissions.
Actively engage and influence the external environment as well as demonstrate the ability to recognize and apply external innovation across Lilly’s drug product portfolio.
Demonstrate learning agility to apply fundamental knowledge/experience to novel problem statements in order to accelerate drug product development.
Lead the development of regulatory strategies including authorship of INDs, NDAs, and response to regulatory inquiries.
Embrace diverse thought, background, and experience to deliver innovative solutions that address unmet technical needs.
Possess strong communication (oral, written), organizational, and leadership skills.
Takes leadership in the supervision of the compliance with regulations, guidelines, procedures, and practices governing drug research and development, including the departmental and corporate standard operating, good manufacturing, and safety procedures.
Experience with developing solid drug products manufacturing processes, and technical transfer of processes into manufacturing operations
Ph.D. in chemical engineering, pharmaceutical sciences or a related field with 6 + years of experience
- B.S. or M.S. with 15+ of demonstrated equivalent experience in a related field of expertise
Authoring regulatory submissions and responding to regulatory questions experience is highly desired
Experience in continuous manufacturing within the pharmaceutical industry is desired: Experience on technical considerations for equipment design and integration, process monitoring, integration of PAT systems, scientific approaches on control strategy and process parameters. Knowledge and application of technical and regulatory considerations for control strategy, batch description, process models integration
Strong technical skills to supply business value
Knowledge and experience with management of a technical project
Demonstrated leadership capabilities in a team environment
Good interpersonal skills and a sustained tendency for collaboration
Demonstrated success in persuasion, influence and negotiation
Good verbal and written communication
Ability to prioritize multiple activities and manage ambiguity
Influence others to promote a positive environment
Demonstrated initiative and risk-taking
Demonstrated technical proficiency and ability to create ideas for future work plans
Demonstrated ability to drive and accept change
Understanding and awareness of the external scientific and regulatory landscape
Passionate about improving technological solutions using new technologies
Demonstrated exemplary teamwork/interpersonal skills
Demonstrated problem solving, attention to detail and result oriented behaviors in a fast-paced environment.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!