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 benefits

Well-being benefits

Job summary

Lilly in Indianapolis, IN is seeking a Senior Advisor/Director to supervise Technical Services/Manufacturing Science for Advanced Therapies. This role guides drug substance strategy, from early development through commercial launch, spanning viral vectors and lipid nanoparticles.

You will mentor scientists, partner with development, QA, and partners, and lead significant investigations to ensure robust control and state-of-the-art manufacturing.

Qualifications

• Master’s or PhD 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.
• Hands-on technical experience with advanced therapy drug substance in viral vectors or non-viral delivery.

Responsibilities

• Lead the technical strategy from development through launch and lifecycle for advanced therapy drug substances.
• Define product control strategy, support specifications, monitor process capability and improve technical agenda.
• Provide technical oversight of external contract manufacturing partners and technology transfer.

Skills

Technical leadership

Mentoring

Cross-functional collaboration

Regulatory minded

Problem solving

Education

Master’s or PhD in biochemistry, molecular biology, chemical engineering, biotechnology, pharmaceutical sciences, or related field

Tools

Viral vector manufacturing

Lipid nanoparticle production

Process validation

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 help 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.

Lilly is expanding its portfolio of advanced therapy medicines, spanning viral vector (AAV and lentiviral) and non-viral delivery (lipid nanoparticle and mRNA) platforms. These are among the most technically demanding modalities in our network, combining rapidly evolving science with a fast-moving regulatory landscape, and are manufactured across both internal Lilly sites and external manufacturing partners.

Job Title

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

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.

Responsibilities

The successful candidate will serve as the technical lead and global technical owner for assigned advanced therapy drug substance programs, leading the technical strategy from early development through commercial launch and lifecycle management. This is an individual contributor and technical leadership role supporting a growing portfolio of multiple advanced therapy modalities. The role focuses on drug substance, spanning both drug substance and drug product for lipid nanoparticle products where the two are closely coupled. Key responsibilities of the role include:

• 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 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 (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).

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

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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance)

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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