Director Formulation Development Jobs in Indianapolis, IN

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.
At Lilly, Synthetic Molecule Design and Development (SMDD) is involved in key activities for the development of synthetic active pharmaceutical ingredients from pre-clinical phases through commercialization of drug substances and drug products. Our scientists and engineers develop key technical and business solutions across the portfolio using their deep technical expertise to accelerate testing of the clinical hypothesis and overall drug development. SMDD delivers on these responsibilities by recognizing diverse talent and cultures are necessary to bring the next generation of life changing medicines to patients.
Position Summary:
Our team is looking for experienced, creative, and energetic candidates to lead unit operation development and process optimization of synthetic drug candidates to support clinical trials, regulatory submission, and product commercialization. The position presents an opportunity to lead dynamic teams comprised of process chemists, analytical chemists, formulation scientists, and engineers.
Responsibilities:

• Possess fluent knowledge in unit operation design, process modeling, process equipment selection, and scale-up methodologies with a drive to challenge existing methods; create and apply cutting edge technology and novel platforms within a time constrained environment.
• Familiarity and working knowledge of modern synthetic organic chemistry.
• Demonstrate high learning agility with the ability to understand and exploit new scientific concepts and methods across multiple disciplines; be able to apply these learnings to a portfolio of small molecule, oligonucleotide, and synthetic peptide modalities.
• Lead and/or supervise the design and development of new synthetic routes for the manufacture of active pharmaceutical ingredients using the most modern technologies, including continuous processing, automated reaction screening, PAT, and modeling and simulation.
• Ability to lead a cross-disciplinary team to evaluate and refine new manufacturing routes, manufacturing technologies, and practices to deliver a challenging portfolio.
• Comfortable with scientific uncertainty and the ability to translate hypotheses into action.
• Encourage 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. Participate in technology transfer activities to CRO/CMO organizations and Lilly manufacturing to ensure processes are technically sound, well developed and characterized, and safe.
• Design laboratory experimentation in support of process design, definition, optimization, and technology transfer objectives. Ability to generate process (and property design) data based on a fundamental understanding of the underlying physical processes. Utilize advancements in technology (PAT) and modeling platforms to understand and direct 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 accomplish 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 process that are readily amenable to efficient drug substance manufacturing.
• Collaborate closely with Product Delivery, Project Management, Quality, Manufacturing, and Regulatory scientists 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.
• Active participant in the external environment and the ability to recognize and apply external innovation and across the Lilly synthetic portfolio.
• Possess deep understanding of the external global regulatory climate and emerging requirements. Ability to address key CMC regulatory questions that enable clinical studies and support marketing authorization applications.

Basic Qualifications:

• Ph.D. in chemical engineering or a closely related field with 8+ years of experience; or MS degree with 15+ years of experience.
• Experience developing chemical processes the from mid-development cycle (proof of concept) to product commercialization required
• Experience with technical transfer of processes into manufacturing operations required

*Experience within the pharmaceutical sector is desired; however, other relevant experience may meet expectations. Prior experience in the development of an active ingredient and associated formulated product is acceptable. Relevant industrial sectors include agrochemicals, nutraceuticals, specialty chemicals, and personal care products.
Additional Skills/Preferences:

• Experience with authoring regulatory submissions and responding to regulatory questions.
• Experience with modeling and simulation tools, data analytics, and predictive analytics.
• Experience with online and offline analytical techniques and process analytical technologies (PAT).
• Strong technical skills to supply business value.
• Creativity and ability to transform ideas into marketable products and processes.
• Knowledge and experience with management of a technical project.
• Demonstrated leadership capabilities especially in a team environment.
• Demonstrated ability to drive and accept change.
• Demonstrated success in persuasion, influence and negotiation.
• Good interpersonal skills and a sustained tendency for collaboration.
• Ability to prioritize multiple activities and manage ambiguity.
• Ability to influence others to promote a positive work environment.
• Understanding and awareness of the external scientific and regulatory landscape.
• Demonstrated initiative and risk-taking.
• Demonstrated technical proficiency and ability to create ideas for future work plans.
• Established external publication record.

Additional Information:

• Travel: 0 -10%
• Position Local: Indianapolis, IN; Lilly Technology Center-North (LTC-N)

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
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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