Sr. Advisor - Global Technical Services Molecule Steward - Dry Products

BioSpace; Indianapolis (IN); On-site; USD 117,000 - 209,000; Full time

Job summary

Lilly in Indianapolis is seeking a Sr. Principal Scientist through Sr. Advisor to lead manufacturing science activities for solid oral dosage forms, bridging Product Development, CM&C, and manufacturing sites to commercialize new products.

The role requires deep technical expertise, cross-functional leadership, and the ability to design rigorous experiments, drive process transfers, prepare regulatory submissions, and mentor others while delivering strategic improvements across sites.

Qualifications

• BS, MS, and/or PhD in Chemistry, Engineering, Pharmaceutical Science, or related science.
• Minimum 7-10 years of direct experience in Oral Solid Dose Form Manufacturing and Development/Commercialization.
• A minimum of 3 years of commercial manufacturing support (post process validation) of solid oral dosage forms with ability to apply this experience to development of new solid oral dosage form products.
• Evidence of technical expertise across multiple areas, unit operations, and platforms related to dry products (oral solid dosage forms) development, commercialization, and commercial GMP manufacturing.

Responsibilities

• Serve as Manufacturing TS/MS representative to integrate commercialization work plans across Product Development, CM&C teams, Manufacturing sites, and applicable functional areas to commercialize new solid oral dosage forms.
• Leverage prior commercial manufacturing and development experience of solid oral dosage forms to anticipate commercial manufacturing challenges for new oral products. Work across Development and Manufacturing site(s) to implement appropriate product control strategies based on anticipated needs.
• Ensure that experiments and technical work plans are well designed and appropriately rigorous. Use first principles and theoretical knowledge to define scientific approaches to support technical expectations.
• Provide proficient data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs.
• Collaborate with Project Managers on key product project plans and support timely delivery of milestones with appropriate risk mitigation strategies.
• Author technical reports and appropriate sections of regulatory submission and responses as needed. Prepare technical aspects of other Regulatory/Quality based documents and support Regulatory reviews and inspections as needed.

Skills

Analytical skills

Technical leadership

Communication

Team collaboration

Education

BS/MS/PhD in Chemistry/Engineering/Pharmaceutical Science

Job description

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.

We are seeking talent at the Sr. Principal Scientist through Sr. Advisor level; the final title and scope will be aligned with the candidate’s experience, organizational impact, and leadership capabilities.

Key Objectives/Deliverables

• Serve as Manufacturing TS/MS (Technical Services/Manufacturing Science) representative to integrate the commercialization work plans across Product Development, CM&C teams, Manufacturing sites, and applicable functional areas to commercialize new solid oral dosage forms.
• Leverage prior commercial manufacturing and development experience of solid oral dosage forms to anticipate commercial manufacturing challenges for new oral products. Work across Development and Manufacturing site(s) to implement appropriate product control strategies based on anticipated needs.
• Ensure that experiments and technical work plans are well designed and appropriately rigorous. Use first principles and theoretical knowledge to define scientific approaches to support technical expectations. Utilize in depth understanding of materials, process, and product to improve product/process robustness, reduce variability, and provide improvement or advanced application of control strategies across sites and technologies.
• Serve as the Global Molecule Steward for select solid oral dosage form drug products. Collaboratively integrate different disciplines such as engineering and analytical science on technical projects, process performance improvements, or control strategy effectiveness. Provide proficient data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs.
• Achieve network level results for Lilly's dry products (solid oral dosage forms) that improve the effectiveness of TS/MS, Lilly Manufacturing, or other parts of the business. Influence global leadership to drive improvements and resolve issues.
• Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites as well as additional technical support/guidance for external manufacturing as needed. Drive appropriate shared learning, alignment and improvement across manufacturing sites according to best practices and technical principles.
• Collaborate with Project Managers on key product project plans and support timely delivery of milestones with appropriate risk mitigation strategies.
• Leverage prior experience and knowledge as a recognized Subject Matter Expert to collaborate with Development and manufacturing sites in the optimization of key manufacturing platforms including continuous manufacturing. Influence Development strategies for new product or platform topics in line with Manufacturing needs. Identify and lead the deployment of new technologies as appropriate.
• Author technical reports and appropriate sections of regulatory submission and responses as needed. Prepare technical aspects of other Regulatory/Quality based documents and support Regulatory reviews and inspections as needed.
• Remain current on external pharmaceutical manufacturing trends and innovations. Leverage these to improve strategies and applications for developing and controlling manufacturing processes.
• Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation. As a reviewer of technical reports, provide input on the experimental findings and conclusions.
• Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors.

Basic Requirements

• BS, MS, and/or PhD in Chemistry, Engineering, Pharmaceutical Science, or related science.
• Minimum 7-10 years of direct experience in Oral Solid Dose Form Manufacturing and Development/Commercialization.
• A minimum of 3 years of commercial manufacturing support (post process validation) of solid oral dosage forms with ability to apply this experience to development of new solid oral dosage form products.
• Evidence of technical expertise across multiple areas, unit operations, and platforms related to dry products (oral solid dosage forms) development, commercialization, and commercial GMP manufacturing.

Preferred Qualifications

• Demonstrated, strong analytical and problem-solving abilities. Effective at integrating multiple technology disciplines to drive programs forward.
• Demonstrated, strong technical leadership and communication skills. Communicates effectively across disciplines and types of audiences (internal and external) to influence and/or drive common understanding and appropriate actions.
• Ability to work well independently, as well as in teams. Provides partnership and collaboration across multiple disciplines.

Additional Preferences

• Flexibility to travel and interact with multiple partners/functions, regions, and cultures.
• Ability to lead cross functional teams effectively. Ability to work independently, and within teams. Provides partnership and collaboration across multiple disciplines.
• Demonstrated, strong analytical and problem-solving abilities.
• Effective at integrating multiple technology disciplines to drive programs forward.

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

$117,000 - $209,000

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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