Sr. Advisor/Director/Sr. Director, TSMS- Advanced Therapies

BioSpace; Indianapolis (IN); On-site; USD 152,000 - 264,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical, dental, vision

Flexible benefits

Life insurance

Well-being benefits

Job summary

Lilly, a global healthcare leader headquartered in Indianapolis, Indiana, seeks a Senior Advisor/Director/Senior Director – Technical Services/Manufacturing Science, Advanced Therapies to drive technical strategy for viral vector and lipid nanoparticle programs. You will partner with development teams, oversee manufacturing readiness, and contribute to regulatory submissions.

This role requires an advanced degree and 8+ years in biopharma manufacturing or technical services, with hands-on

Qualifications

• Master’s or PhD in a related scientific discipline.
• Minimum of eight years in biopharmaceutical drug substance manufacturing, process development or technical services in GMP.
• Hands-on experience with advanced therapy modalities (viral/vector or lipid nanoparticle/mRNA).

Responsibilities

• Define and own product control strategy with development orgs.
• Represent TS/MS on cross-functional teams for manufacturing readiness and process validation.
• Provide oversight of external contract manufacturers and tech transfer.
• Author/review CMC regulatory submissions and responses.
• Lead viral vector and lipid nanoparticle manufacturing technical leadership.
• Collaborate on potency, infectivity, and cryogenic handling strategies.
• Lead complex process investigations and change controls.
• Ensure state of control with QA/QC functions.
• Teach and mentor scientists across the network.

Skills

Viral vector manufacturing

Lipid nanoparticle production

mRNA production

Process development

Technical leadership

GMP/compliance

External partner oversight

Education

Master’s or PhD in biochemistry/molecular biology/chemical engineering/biotech/pharmaceutical sciences

Tools

Chromatography

Transfection

Cell culture

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Introduction

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

The TS/MS organization provides technical oversight to ensure robust and consistent biology and chemistry throughout all aspects of Lilly’s manufacturing process. Through cross functional collaboration, TS/MS ensures the quality and safety of our products through process monitoring and knowledge to control, prevent and mitigate variability to deliver a reliable supply of medicine. Within TS/MS, the central commercialization team provides global technical stewardship for products from early development through launch and across the commercial lifecycle, working across internal manufacturing sites and external partners.

Job Title: Senior Advisor / Director / Senior Director – Technical Services/Manufacturing Science, Advanced Therapies

Responsibilities

• Partnering with development organizations, define and own the product control strategy, support establishment of specifications, monitor process capability, and set the technical improvement agenda for assigned products
• Represent technical services on cross functional product and governance teams, providing technical positions on manufacturing readiness, process validation and ongoing product performance
• Provide technical oversight of external contract manufacturing partners, including technology transfer, process comparability assessments, technical content for quality and technical agreements, and on-site support during manufacturing campaigns
• Author and review CMC sections of regulatory submissions, manage responses to health authority questions, and support post-approval changes; apply global regulatory expectations and relevant ICH guidance for viral vector and nucleic acid products
• Provide technical leadership on viral vector manufacturing challenges including transfection and producer cell line performance, downstream purification, and full/empty capsid separation
• Provide technical leadership on lipid nanoparticle and mRNA manufacturing challenges including encapsulation efficiency, lipid analytics, and in vitro transcription performance
• Partner with analytical development on potency, infectivity and subvisible particulate characterization strategy, and address cryogenic handling and cold chain integrity requirements for frozen products
• Lead complex process-related investigations and assess technical impact; own or support large process-related change controls with greater risk, resource or complexity
• Partner closely with the quality assurance and quality control functions to provide technical oversight of the control strategy and ensure manufacturing processes remain in a state of control
• Teach, coach and mentor scientists and engineers across the network in an emerging field where platform knowledge and precedent are still developing, setting the standard for scientific curiosity and technical rigor

Basic Requirements

• Master’s or PhD degree in biochemistry, molecular biology, chemical engineering, biotechnology, pharmaceutical sciences, or related scientific discipline
• Minimum of eight years of experience in biopharmaceutical drug substance manufacturing, process development or technical services within a GMP environment, in any biopharmaceutical modality.
• Hands-on technical experience with advanced therapy drug substance in either viral vector (AAV and/or lentiviral) or non-viral delivery (lipid nanoparticle / mRNA). Depth in one platform is acceptable, with the capability and willingness to develop breadth across both. This experience may have been gained in a development, laboratory or GMP manufacturing setting

Additional Skills/Preferences

• Knowledge of viral vector drug substance manufacturing, including transient transfection, producer or packaging cell lines, and chromatographic and density-based purification
• Knowledge of non-viral delivery drug substance manufacturing, including in vitro transcription and mRNA production, microfluidic or impingement-jet lipid nanoparticle formation, and encapsulation analytics
• Experience spanning drug substance and drug product, particularly for lipid nanoparticle products where the two are closely coupled
• Experience providing technical oversight of contract manufacturing partners, including comparability and technology transfer
• Experience contributing to advanced therapy regulatory submissions and health authority interactions
• Knowledge of qualification and validation requirements and good manufacturing practices
• Demonstrated strong proclivity for technical leadership, teaching and mentoring, with the ability to transfer knowledge to all levels of the organization
• Self-starter with high initiative, a data-driven approach to problem-solving, and demonstrated adaptability working in fast paced environments where established precedent is limited

Additional Information

This position may be filled at a level commensurate with the successful candidate’s experience and technical depth

Travel of up to 30% is expected, including travel to internal manufacturing sites, contract manufacturing partner sites, and external scientific and regulatory forums

Role is Monday through Friday based. Must be flexible to accommodate collaboration across global time zones and to support manufacturing campaigns at internal and partner sites

Location: Indianapolis, IN USA

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.

The anticipated wage for this position is

$151,500 - $264,000

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

• 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
• 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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