Sr. TS/MS Scientist – Secondary Loop

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$64,500 - $167,200

Company Overview

At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.

This role is at the CORE Indianapolis facility, formerly Point Biopharma.  The Center of Radioligand Excellence (CORE) is responsible for the Commercial launch of RLTs, Supply of late-stage investigational products, and scale-up/optimization for Ph3 and commercial launches.  This role will report within the Facilities and Engineering team.

Responsibilities

The TS/MS - Secondary Loop is a key member in a cross-functional team who provides technical assistance and guidance to Floor Support staff to achieve reliable and compliant manufacture of radiopharmaceutical drug product to predetermined global quality standards via a detailed set of manufacturing instructions and procedures. This role is the expert for the control strategy of the product(s) and process(es) for which they are assigned.

Key Objectives/ Deliverables

• Understand the scientific principles required for manufacturing RLT drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
• Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
• Ensure that there is an accurate process flow diagram that describes the process, control strategy, process parameters and critical quality attributes.
• Create and maintain master batch record ensuring accurate instruction set to execute the control strategy for the discrete manufacturing steps.
• Ensure process remains in a validated state through routine monitoring.
• Ensure timely completion of annual product reviews (APRs) and Ongoing Process Verification (OPV), with action plans defined and monitored to ensure processes are in control, capable and in continuous improvement.
• Prepare, review, approve, and provide technical support for preparation of relevant technical documents, such as: change controls, deviation investigations, technical studies and summary reports, risk assessments, and control strategies.
• Support and / or lead technical agenda projects (experimental, modeling and / or production data analysis) to improve process control, yield, purity, and / or productivity.
• Lead, mentor, and coach process team personnel on product control strategy and technical matters.
• Work with cross functional support groups and external partners to resolve or provide advice on product related issues.
• Work within cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and site objectives.
• Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.

Basic Qualifications

• Bachelor’s in relevant field (preference for scientific disciplines such as Chemistry, Radiochemistry, Biochemistry, Pharmacy, Bio/Chemical Engineering).
• 2+ years of experience supporting pharmaceutical manufacturing

Additional Skills/ Preferences

• Ability to work independently and with minimal supervision.
• Technical leadership capabilities, and the ability to train/coach others.
• Ability to influence and communicate to diverse groups on complex regulatory, business, or technical issues within the site and function.
• Technical writing and communication skills are used daily and the ability to effectively communicate and transfer knowledge to all levels of the organization is essential.  
• Proficiency in delivering highly complex tasks and / or tasks that are highly cross-functional.
• Strong analytical and quantitative problem-solving skills.