TS/MS Principal Scientist – Dry External Manufacturing

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.

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 150 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. Lilly knows its business has prospered because of its employees – people with a talent for innovation and a passion for making a difference by finding treatments for the most stubborn diseases; people whose talent is matched by their generosity, and people with strong values and a determination to prevail, regardless of the challenges. Join our team – and make a difference in improving health for people all over the world!

Manufacturing and Quality Technical Hub Hyderabad
Lilly has made a strategic investment of more than $1B dollars to establish a Manufacturing and Quality technical hub in Hyderabad, India. This hub will oversee the significant investment in contract manufacturing and the technical services responsible for managing the scientific agenda for manufacturing and quality. The hub will be recruiting top talent in the areas of manufacturing operations, quality assurance, quality control, supply chain, technical services, and engineering to build a cutting-edge scientific organization supporting the exciting dry products external manufacturing portfolio of Lilly.

Job Description

Role Overview and Key Responsibilities:
The TSMS Representative role provides the technical support and leadership required to achieve the reliable and compliant manufacture of Dry Products External Manufacturing (Dry-EM). The TSMS Representative works with the technical staff responsible for the development and delivery of programs for continuous process optimization and improvement.

Key Objectives/Deliverables:

• Understand the scientific principles required for manufacturing drug products, including the interaction of formulation and equipment. Develop and steward operational control strategies.
• Serve as a technical leader and mentor for Scientists, Managers, and other disciplines.
• Maintain interface with the TS/MS function, development, customers, and contract manufacturing organizations.
• Manage TS/MS technical projects (experimental, modeling, and/or production data analysis) to improve process control, yield, and/or productivity.
• Provide technical support for preparation of relevant technical documents: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, etc.
• Review/approve relevant technical documents: Change Controls, Regulatory Submissions, Expert Opinions, Deviations, Validations, Tickets, Procedures, PFDs, etc.
• Remain current with all applicable regulations (global GMP expectations, regulatory expectations, health, safety, and environmental regulations).
• Provide support to internal and joint process teams.

Basic Requirements:

• Bachelor's or Masters Degree or equivalent work experience in scientific disciplines of Pharmacy, Pharmaceutical Science, Pharmaceutical Engineering, Biochemistry, Organic Chemistry, Physical Chemistry, Bioanalytical Chemistry, Microbiology, Analytical Chemistry, Materials Science, or Engineering.
• Minimum of 10 years of demonstrated experience aligning with delivery of and assuring cGMP compliance of a production operation.
• Relevant industrial experience in dry operations technology, especially in technical services, and in any of the following: Development, Manufacturing, or Quality Assurance.
• Thorough understanding of cGMPs and drug product manufacturing.
• Strong leadership, interpersonal, and teamwork skills; able to work effectively in a team environment.
• Good communication skills, especially attention to detail in written procedures and protocol development.
• Capability to work in a virtual and complex environment.
• Willingness to travel and appreciation for cultural diversity and inclusive leadership.

Additional Preferences:

• Experience in Statistical Process Control (SPC) and Six Sigma or Lean Tools.
• Ability to work independently as well as part of a team.
• Good judgment and flexibility.
• Language: English (proficient).

Other Information:

• Off-hours support of operations may be required.
• Travel is possible, at least 30%.

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 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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