TSMS-API Manufacturing Support Scientist

Eli Lilly and Company

Hyderabad

On-site

INR 1,500,000 - 2,500,000

Full time

14 days+

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Job summary

A leading pharmaceutical firm in Hyderabad is seeking a TSMS-API Manufacturing Support Scientist to ensure technical support in the manufacturing of API drug substances. The ideal candidate will have over 10 years of experience in API manufacturing with a PhD in a relevant field. Responsibilities include providing technical oversight, ensuring compliance with regulations, and leading projects to improve manufacturing processes. This full-time role offers a mid-senior level position in a dynamic environment.

Qualifications

Minimum of 10 years relevant industrial experience in API and API intermediate manufacturing.
Demonstrated basic knowledge of small molecule API manufacturing.
Familiarity with cGMP manufacturing environment and terminology.

Responsibilities

Provide technical oversight and stewardship for manufacturing processes.
Ensure compliance with US and global regulations.
Lead resolution of technical issues related to manufacturing.
Execute technical projects to improve process control and productivity.
Analyze data and ensure proper documentation.

Skills

Analytical skills

Interpersonal skills

Communication skills

Teamwork

Flexibility

Education

PhD in Organic Chemistry, Chemical Engineering, or Physical Chemistry

Job description

TSMS-API Manufacturing Support Scientist

Join to apply for the TSMS-API Manufacturing Support Scientist role at Eli Lilly and Company.

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 work to discover and bring life‐changing medicines, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We’re looking for people who are determined to make life better for people around the world.

Key Objectives/Deliverables

The TS/MS person‑in‑plant (PIP) manufacturing scientist provides technical support to ensure the reliable and compliant manufacture of API drug substances that meet global quality standards. The role involves leadership and functional‑area expertise at the designated contract manufacturer site, in collaboration with API EM contract manufacturing personnel at Lilly affiliate sites.

Detailed Responsibilities

Providing technical oversight and stewardship for manufacturing processes.
Ensuring processes are compliant with US and global regulations, capable, in control, and maintained in a validated or qualified state.
Technical transfer document preparations and support activities.
Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
Leading resolution of technical issues including those related to control strategy and manufacturing.
Executing technical projects to improve process control, yield, purity, and/or productivity.
Ensuring proper characterization of processes and products and ensuring effective documentation of the process description, measures, acceptable ranges, and specifications.
Understanding, justifying, and documenting the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
Preparation of relevant technical documents such as technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, etc.
Developing and monitoring established metrics in real‑time to assess process variability and capability.
Ensuring that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
Analyzing data and ensuring appropriate documentation.
Writing technical reports and documents.
Day‑to‑day production support.
Monitoring ongoing production support (e.g., production meeting attendance).
Periodic housekeeping / fit & finish walk‑throughs with area management.
Tracking resolution of identified issues.
Practice vs procedure walk‑throughs at the CM sites.
Serving as an active member of the Lilly process teams (IPT, JPTs, & GPLOTs).
Conformance of CAPA implementation.
Effective management of internal and external stakeholders.
Adhering to Lilly’s Business, Quality, and Financial Systems.
Operating with a "Team Lilly" mindset.

Basic Requirements

Minimum of 10 years relevant industrial experience in API and API intermediate manufacturing within the technical services (TS/MS) or small molecule process development and scale‑up.
Demonstrated basic knowledge of small molecule API manufacturing.
Familiarity with cGMP manufacturing environment and terminology.

Additional Preferences

Excellent analytical, interpersonal, written and oral communication skills.
Ability to work independently as well as part of a team.
Ability to prioritize activities.
Good judgment and flexibility.

Education Requirements

PhD in Organic Chemistry, Chemical Engineering, or Physical Chemistry.

Other Information

Complete learning plan for API EM TS/MS role.
Tasks require entering manufacturing areas which require wearing appropriate PPE.
Domestic and International Travel (variable, can approach 20%).

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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Seniority Level