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:

- Bachelors 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.
- Positive 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 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.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 TS/MS Principal Scientist Dry External Manufacturing (Hyderabad)
🏢 Eli Lilly
📍 Hyderabad