Sr. Scientist TS/MS - Parenteral Manufacturing

BioSpace; Indianapolis (IN); On-site; USD 64,000 - 168,000; Full time

Job summary

A leading global healthcare company is looking for a Sr. Scientist to provide scientific leadership and technical support in parenteral manufacturing. In this role, you will ensure the quality and compliance of drug products, working in collaboration with cross-functional teams to drive continuous improvement in processes. Ideal candidates will have a bachelor's degree in a scientific discipline and practical experience in pharmaceutical manufacturing.

Benefits

Comprehensive benefit program, including medical, dental, and vision.

401(k) and pension plan.

Flexible healthcare benefits.

Employee assistance program.

Qualifications

• 2-3 years supporting pharmaceutical manufacturing or quality, experience in aseptic manufacturing preferred.
• Experience in Visual Inspection of injectable products preferred.
• Proficiency in delivering complex tasks and/or cross-functional tasks.

Responsibilities

• Understand scientific principles for manufacturing parenteral drug products, including interaction of chemistry, equipment, and processes.
• Develop and monitor statistical metrics to assess process variability.
• Prepare and provide technical support for relevant documentation.

Skills

Analytical skills

Project Management

Technical communication

Problem Solving

Education

Bachelors in scientific disciplines (Biochemistry, Chemistry, Microbiology, Pharmacy, or Engineering)

Job description

Sr. Scientist TS/MS - Parenteral Manufacturing

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Sr. Scientist TS/MS - Parenteral Manufacturing

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Join to apply for the Sr. Scientist TS/MS - Parenteral Manufacturing role at BioSpace

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.

Organization Overview

The mission of Technical Services/Manufacturing Sciences (TS/MS) is to provide scientific leadership and technical support for manufacturing to make medicine today and tomorrow. The Secondary Loop Scientist provide technical support to achieve the reliable and compliant manufacture of parenteral drug product to predetermined global quality standards. The Secondary Loop Scientist provides additional support to the manufacturing operations through either product/project/process focused ownership. This person interacts daily with a wide variety of people, including customers, other personnel and site management.

Responsibilities

• Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems on inspection processes.
• Ensure that an accurate instruction set (tickets & procedures) and process flow document describe the process as performed and the control strategy for the discrete manufacturing steps.
• Develop, monitor and appropriately react to established statistically based metrics in real-time to assess process variability and capability.
• Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
• Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, process flow documents, validation master plans, annual product reviews, periodic monitoring, etc.
• Participate in development and implementation of process improvements, including capital expansions and technical projects. Work within or lead cross- functional teams in positive fashion to implement technical objectives and deliver on business plan, quality objectives or to improve process control, yield, and/or productivity.
  
  
  

Minimum Requirements

• Bachelors in scientific disciplines of Biochemistry, Chemistry, Microbiology, Pharmacy, or Engineering are minimum requirements.
• Must have 2-3 years of experience directly supporting pharmaceutical manufacturing or quality, with experience in aseptic manufacturing preferred.
  
  
  

Additional Information

• Experience in Visual Inspection of injectable products preferred.
• Ability to influence and communicate to diverse groups on business, or technical issues within the site and function.
• Responsible for maintaining a safe work environment.
• Experience in statistics and stackable tolerance analysis.
• Builds relationships with internal and external customers and partners.
• Proficiency in delivering complex tasks and/or tasks that are cross-functional.
• Demonstrated Project Management skills and ability to coordinate complex projects.
• Strong analytical and quantitative problem solving skills.
• Strategic thinking and ability to balance short term needs with long term business evolution.
• This position is day shift, Monday-Friday, with off hours support needed, by request.
  
  
  

This job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification.

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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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