Director - BRD Analytical Development

BioSpace; Indianapolis (IN); On-site; USD 140,000 - 218,000; Full time

Benefits offered by this job

Company bonus

401(k) and pension

Medical, dental, vision benefits

Paid time off

Job summary

Lilly, headquartered in Indianapolis, IN, seeks experienced professionals to lead analytical sciences across drug substances and products. The role supports regulatory submissions, IND/CTA and BLA/NDA activities within a multidisciplinary team and external partners.

You will mentor staff and drive optimization of modalities from peptide to gene therapies as needed. The position is onsite in Indianapolis with travel up to 15% and a comprehensive benefits program.

Qualifications

• Ph.D. in Analytical Chemistry or Bioanalytical Chemistry with 5+ years in the pharmaceutical industry.
• Experience leading analytical efforts for drug substance/product development and commercialization; introduced new methodologies.
• Experience developing global regulatory strategies and authoring regulatory submissions.

Responsibilities

• Lead analytical efforts for drug substance/product development and regulatory submissions.
• Develop analytical methods, specifications, and stability studies.
• Author IND/CTA, BLA/NDA/MAA, RtQ and respond to regulatory questions.
• Transfer technology to CRO/CMO networks and Lilly sites.
• Mentor and develop scientific staff and drive knowledge sharing.

Skills

Analytical chemistry

Pharma development

Regulatory submissions

Leadership

Mentoring

Education

Ph.D. in Analytical/Bioanalytical Chemistry

B.S. in Chemistry with 15+ years

M.S. in Chemistry with 10+ years

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.

Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Summary

In this role, we are seeking experienced, innovative, and motivated candidates to apply their strong foundation in analytical sciences and experience in pharmaceutical development to enable clinical trials, regulatory submissions, and new product commercialization. This role offers the opportunity to lead drug substance and/or drug product analytical efforts within a multidisciplinary team while offering access to word-class capabilities for pharmaceutical development.

Responsibilities

• Possess prior experience leading analytical efforts focused on pharmaceutical drug substance and/or drug product development and commercialization, as well as demonstrate familiarity with applicable regulatory requirements and emerging trends in the industry.
• Demonstrate a depth of knowledge in concepts relevant to drug substance and drug product commercialization, including developing analytical methods, justifying specifications, designing stability studies, authoring regulatory submissions and addressing questions from global regulatory agencies.
• Drive the implementation of technical solutions and analytical strategies to enable drug substance and drug product process design.
• Collaborate with project teams to deliver robust control strategies for drug substances and drug products and/or intermediates.
• Have experience authoring IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ).
• Provide technical guidance for analytical activities executed within the external network. Ensure methods are technically sound, well developed and fit-for purpose. Execute technology transfer to CRO/CMO organizations and Lilly manufacturing sites.
• Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas; be able to use these techniques to bring value across a portfolio of peptide, oligonucleotide, monoclonal antibody, gene therapy, and/or bioconjugate modalities.
• Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing.
• Responsible for introduction of new methodologies for optimization of existing modalities or development of control strategies for new modalities.
• 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 closely with organizations across Discovery, Development, and Manufacturing to execute and deliver material and information for clinical trials and regulatory submissions.
• Embrace diverse thoughts, backgrounds, and experiences to deliver innovative solutions.
• Possess strong communication (oral, written), organizational, and leadership skills.
• Actively engage in the external environment and the ability to recognize and apply external innovation across the Lilly synthetic portfolio.

Basic Requirements

• Ph.D. in Analytical Chemistry or Bioanalytical Chemistry, with 5+ years of experience in the pharmaceutical industry after earning degree; or alternatively a B.S. in Chemistry with 15+ years of experience; or M.S. in Chemistry with 10+ years of experience.
• Prior experience leading analytical efforts focused on pharmaceutical drug substance and/or drug product development and commercialization, as well as demonstrated familiarity with emerging trends in the industry. Introduced new methodologies for optimization of existing modalities or development of control strategies for new modalities.
• Experience in developing global regulatory strategies including authoring regulatory submissions, responding to regulatory questions, and/or registering products across global markets. Authored IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ).
• Experience with management of technical projects. Provided technical guidance for analytical activities executed within the external network. Ensured methods are technically sound, well developed and fit-for-purpose. Executed technology transfer to CRO/CMO organizations and Lilly manufacturing sites.
• Possesses strong communication (oral, written), organizational, and leadership skills. Demonstrated ability to drive and accept change.
• Mentored and developed scientific staff. Ensured continued technical and professional growth of group members, encouraged efforts towards excellence and knowledge sharing. Demonstrated leadership capabilities especially in a team environment.

Additional Preferences

• Strong technical skills to enable innovation which creates business value.
• Creativity and ability to transform ideas into marketable products and processes.
• 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.
• Demonstrated technical proficiency and ability to create ideas for future work plans.

Additional Information

Travel: 0 to 15%

Potential exposure to chemicals, allergens, and loud noises.

Position is onsite: Indianapolis, IN; Lilly Technology Center-North (LTC-N)

Physical Demands/Travel

The physical demands of this job are consistent with a lab environment.

Work Environment

This position’s work environment is in a Laboratory.

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

The anticipated wage for this position is

$139,500 - $217,800

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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