At Lilly, Small Molecule Design and Development (SMDD) is involved in key activities for the development of synthetic drug substances and drug products starting with pre-clinical phases through commercialization. Our scientists and engineers develop innovative technical and business solutions using their deep technical expertise to accelerate testing of the clinical hypothesis and overall drug development. Through recognizing the value of a culturally diverse workforce, SMDD delivers on these responsibilities and helps bring the next generation of life changing medicines to patients.
Our team is looking for experienced, creative, and energetic technical leaders to lead overall control strategy development, unit operation optimization and process optimization of synthetic drug candidates to support clinical trials, regulatory submission, and product commercialization. This position presents an opportunity to lead dynamic teams comprised mainly of process chemists, analytical chemists, and engineers. Top candidates for this position will be expected to:
Possess experience leading multiple drug substance and drug product teams through Common Technology Document (CTD) authoring, NDA submission, Pre-approval inspection (PAI) readiness of manufacturing sites, and Country-specific Response to Questions (RtQ) approaches leading to successful submissions
Possess fluent knowledge of unit operation design, process modeling, process equipment selection, conducting data rich experiments, PAT utilization in the laboratory and production facilities, and scale-up methodologies with a drive to challenge existing methods; create and apply groundbreaking technology and novel platforms within a time constrained environment
Exhibit familiarity and knowledge of synthetic organic chemistry, synthetic strategy, and synthetic route development
Demonstrate high learning agility and the ability to exploit scientific concepts and methods across multiple disciplines (e.g., continuous processing, automated reaction engineering, and modeling and simulation); be able to apply these techniques in order to bring value across a portfolio of small molecule, oligonucleotide, and synthetic peptide modalities
Demonstrated ability to lead and/or supervise a cross-disciplinary team to evaluate and refine new manufacturing routes, manufacturing technologies, and practices to deliver a challenging portfolio
Lead decisively in the presence of scientific uncertainty and translate hypotheses into action
Inspire team members to take initiative and accountability to achieve goals; draws out and encourages others to share knowledge
Provide technical guidance in the scale-up and demonstration of new chemical processes in development and commercial scale equipment. Ensure processes are technically sound, well developed and characterized, and safe. Manage technology transfer activities to CRO/CMO organizations and Lilly manufacturing.
Design laboratory experimentation in support of process design, definition, optimization, and technology transfer objectives. Demonstrate the ability to generate process (and property design) data based on a fundamental understanding of the underlying physical processes. Utilize advancements in process analytical technology (PAT) and modeling platforms to understand and lead experimental protocols
Plan and manage short term and long-term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource allocation to deliver projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.
Collaborate with internal and external manufacturing partners to develop robust chemical processes that are readily amenable to efficient drug substance manufacturing
Collaborate closely with organizations outside SMDD such as Product Delivery, Project Management, Quality, Manufacturing, and Regulatory to execute and deliver material and information for clinical trials and regulatory submissions
Embrace diverse thought, background, and experience to deliver innovative solutions
Possess strong communication (oral, written), organizational, and leadership skills
Supervise, mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing
Actively participate in the external environment and apply external innovation across the Lilly synthetic portfolio
Possess deep understanding of the external global regulatory climate, emerging requirements, and the ability to address key CMC regulatory questions that enable clinical studies which support marketing authorization applications
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.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you are an individual with a disability and require a reasonable accommodation to participate in the application process, please email Lilly Recruiting Compliance. Please note, this email address is intended for use only to request a disability accommodation, please email Lilly Recruiting Compliance for further assistance. Inquiries which are not requests for accommodations may not receive a response.
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