Director/Sr Director/Executive Director Central TSMS for Oligonucleotides

Eli Lilly and Company; Indianapolis (IN); On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a dynamic individual to join their Active Pharmaceutical Ingredient team. This role involves overseeing the technical aspects of oligonucleotide manufacturing, ensuring robust control strategies, and driving process optimizations. The successful candidate will collaborate closely with cross-functional teams to facilitate technology transfers and regulatory submissions. With a commitment to excellence and innovation, this opportunity allows you to make a significant impact on the development of life-changing medicines while working in a supportive and collaborative environment. If you are passionate about advancing healthcare and thrive in a dynamic setting, this position is perfect for you.

Qualifications

• 5+ years of experience in pharmaceutical manufacturing.
• Proficiency with regulatory expectations and oligonucleotide experience preferred.

Responsibilities

• Lead technical aspects of API manufacturing and ensure compliance.
• Develop relationships with development organizations for innovative solutions.

Skills

Pharmaceutical Manufacturing

Regulatory Knowledge

Analytical Control Strategy

Technical Issue Resolution

Communication Skills

Education

MSc/Ph.D. in Biochemistry

MSc/Ph.D. in Chemistry

MSc/Ph.D. in Chemical Engineering

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.

Company Overview

Lilly, a leading innovation-driven corporation is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly makes life better – through medicines and information – for some of the world’s most urgent medical needs. Founded over 145 years ago, the company has sustained a culture that values excellence, integrity and respect for people. This has resulted in Lilly frequently being ranked as one of the best companies in the world at which to work. Join our team – and make a difference in improving health for people all over the world!

Job Description

Join the energetic and growing Active Pharmaceutical Ingredient -Technical Services Manufacturing Science Central Team that delivers a diverse portfolio of drug substances essential to Lilly! As our portfolio is expanding, we have exciting new positions available in the development of our new oligonucleotide manufacturing platform. Oligonucleotide therapeutics are being successfully used to treat disease states as a credible alternative to protein-targeting products. Here in Lilly, we have an exciting pipeline of products on this emerging platform that require critical expertise to ensure robust operating control strategies and manufacturing focused scientific capability. The Central API TSMS Director/Executive Director will provide technical and scientific expertise within a dynamic and growing team that is supporting delivery of commercialization efforts including technical transfers, process validations, and process optimization for the oligonucleotide portfolio. The successful candidate will oversee technical aspects of the development of API manufacturing, including technical depth of understanding of unit operations, technical transfers and process validation strategy. This position requires comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real-world solutions.

Key Objectives/Deliverables:

• Become Network Subject Matter Expert in oligonucleotide API synthesis to support growing portfolio of products.
• Develop critical relationship with Lilly’s Development Organization in the establishment of synthetic approach to oligonucleotides with innovative solutions for commercial transfer – from synthesis to purification.
• Establish depth of understanding of control strategy (CS) of molecules and translate this control strategy into unit operation requirements to ensure robust and right first time technology transfer to commercial facilities.
• Have a depth of understanding of the analytical control strategy that allows critical technical review of the implementation of the analytical CS, including process analytical technology for on line and at line monitoring and control. Understand all critical quality attributes and any analytical method challenges leading to variability that is separate from process variability.
• Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
• Lead resolution of technical issues including those related to control strategy and operational challenges.
• Employ excellent communication skills to manage internal and external relationships in cases where manufacturing facilities are managed by the External Manufacturing teams.
• Build and maintain relationships with central technical organizations to allow for development of innovative solutions, be it technology or process design, that will require cross functional support for development and implementation.
• Ensure proper characterization of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, and specifications (and the justification of these measures, acceptable ranges, and specifications).
• Drive or support initial technology transfers of the oligonucleotide pipeline assets into commercial scale facilities (internal or external) with successful process validation and product yield delivery.
• Work closely with Development and Global Regulatory teams to author/review regulatory submission documents and subsequently respond to Information Requests/Regulatory Questions.
• Ensure that processes are compliant, capable, in control, and maintained in a validated state.
• Successfully deliver on functional strategic initiatives.
• Influence and implement the network technical agenda and drive continuous improvement.
• Understand the chemistry and stability of biomolecules.
• Operate with ‘TeamLilly’ in mind – including coaching and mentoring of peers and other scientists.

Basic Requirements:

• MSc/Ph.D. in scientific disciplines of Biochemistry, Chemistry, Chemical Engineering, or related fields with min 5 yrs experience, or equivalent overall industry experience (10 years +).
• Demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.
• Oligonucleotide experience preferred.
• Proven experience at leading post launch technical agendas and delivering projects that have driven substantial step changes in manufacturing.
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment positions on the B or S paths or at levels M1-M2 or P1-P4.

Additional Information

• Occasional travel required 5 – 10%.

LOCATION:

• Indianapolis, IN

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 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.

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