All Of Our Groups

Healthcare

DirectorProcessChemistrySMDD

$149–257k Indianapolis, Indiana, United States FULL TIME
The Brief

“Director Process Chemistry SMDD at All Of Our Groups. Skills: Process chemistry, Synthetic route commercialization, API development, Regulatory submissions. Demonstrate expertise in synthetic organic and process chemistry. Address key CMC challenges”

What You'll Achieve.

Accelerate testing of clinical hypothesis; Accelerate drug development; Deliver next generation medicines; Support clinical trials; Support product commercialization; Support regulatory submissions; Deliver an exciting portfolio; Enable clinical studies; Support marketing authorization applications

Industry & Context.

Healthcare
Problems you'll solve

Address CMC challenges; Troubleshooting

Eligibility Requirements

0 to 10% travel

What They're Looking For.

Must Have

Ph. D. in organic chemistry or related field with 10+ years pharmaceutical process development experience, MS in Organic Chemistry or related field with 15+ years experience

Nice to Have

Experience within pharmaceutical sector, Experience developing chemical processes from mid-development cycle to commercialization, Experience with technical transfer of processes into manufacturing operations, Experience with authoring regulatory submissions, Responding to regulatory questions, Established external reputation, Publication record, Knowledge and experience with management of a technical project, Ability to build ideas for future work plans, Experience with modern analytical techniques, Experience with process analytical technologies (PAT), Experience with predictive analytics, Ability to transform ideas into marketable products and processes, Demonstrated leadership capabilities, Ability to prioritize multiple activities, Ability to handle ambiguity, Ability to influence others to promote a positive work environment

What You'll Do.

Demonstrate expertise in synthetic organic and process chemistry

Address key CMC challenges

Lead design and development of new synthetic routes

Manufacture API using modern technologies

Understand and exploit new scientific concepts

Apply scientific concepts to small molecule

Understand unit operation design

Understand process modeling

Understand process equipment selection

Build and apply groundbreaking technology

Apply novel platforms within time constraints

Lead team to evaluate and refine manufacturing routes

Evaluate and refine manufacturing technologies

Evaluate and refine manufacturing practices

Deliver an exciting portfolio

Provide technical leadership in scale-up

Demonstrate new chemical processes

Collaborate in technology transfer activities

Ensure processes are technically robust

Ensure processes are well developed

Ensure processes are characterized

Ensure processes are safe

Design experimental laboratory plans

Support route and process design

Support process definition

Support process optimization

Support technology transfer objectives

Integrate process data

Integrate property design data

Apply advancements in technology

Apply advancements in modeling platforms

Lead experimental protocols

Leverage high throughput experimental platforms

Accelerate reaction discovery

Plan and lead development

Develop technical agendas

Develop project timelines

Advise resource allocation

Accomplish projects according to plans

Propose changes in timeline

Propose changes in objectives

Propose changes in direction

Collaborate across internal CMC networks

Implement and deliver material for clinical trials

Implement and deliver information for clinical trials

Implement and deliver material for regulatory submissions

Implement and deliver information for regulatory submissions

Understand external global regulatory climate

Understand emerging regulatory trends

Address key CMC regulatory questions

Enable clinical studies

Support marketing authorization applications

Embrace diversity in thoughts

Embrace diversity in background

Embrace diversity in experiences

Supervise scientific staff

Mentor scientific staff

Develop scientific staff

Encourage team members to take initiative

Encourage team members to take accountability

Draw out knowledge on challenging technical issues

Encourage others to share knowledge

Collaborate in external scientific environment

Exhibit influence in external scientific environment

Recognize external innovation

Integrate external innovation across Lilly synthetic portfolio

How You'll Work.

Team & Collaboration

Cross-disciplinary teams; Internal CMC networks; External scientific environment

Communication Scope

Progress communication; Technical agendas

Process & Methodology

Technical project management, Timeline development, Resource allocation

Free ATS check

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