Chemistry Manufacturing Controls

2 weeks ago

Indianapolis Indiana, United States Eurofins USA PSS Insourcing Solutions Full time
Job Description

Position Overview:

This position will provide strategic, tactical, and operational direction and support to expedite development of our client’s clinical trial portfolio by helping to develop successful regulatory strategies and submissions in support of clinical trials. 

In order to meet client expectations, it is necessary for our entire PSS team to develop collegial and mutually productive relationships with client GRA-CMC team members and other key stakeholders. 

This position utilizes CMC technical knowledge and regulatory expertise to drive internal consistency and influence effective change management. This team will be expected to influence and execute regulatory strategies that can accelerate the development of assigned project(s).

Job Responsibilities:

Include but are not limited to:

Leads preparation, technical and regulatory review, and finalization of CMC sections for global CTA submissions and responds to questions.

Takes a proactive leadership role in the critical review of molecule-specific GRA-CMC development strategies and submission content. 

Makes technical decisions on CMC regulatory issues impacting product submissions across geographies, with support or guidance from Client GRA-CMC regulatory scientists.

Networks and gains alignment with CMC team members and GRA-CMC regulatory scientists to resolve complex issues.

Assists in the development of regulatory strategy and update strategy based upon global regulatory changes

Provide high quality, timely and clear regulatory advice to allow CMC teams to make well-informed decisions

Evaluate regulatory impact on proposed CMC development plans

Anticipates and resolves key technical or operational issues that can impact the function or CMC team.

Participates in risk-benefit analysis for regulatory compliance.

Develop relationships with GRA-CMC team members that promote open discussion of issues to enable regulatory influence of drug development strategies.

Communicates effectively verbally and in writing to influence within GRA-CMC and with CMC development team.

Demonstrated negotiation and influence skills. Demonstrated effective teamwork skills, able to adapt to diverse interpersonal styles.

Proactively identifies and resolves global CMC regulatory issues.

Partners with Client GRA CMC (regulatory scientists) develop complex regulatory strategies.

Partners with Client RDE (regulatory associates/publishing group) to ensure completion of submission activities.

  • Chemistry Manufacturing Controls CMC Analyst

    1 week ago

    Indianapolis, United States Eurofins USA PSS Insourcing Solutions Full time

    Job Description ** Position Overview: ** This position will provide strategic, tactical, and operational direction and support to expedite development of our client’s clinical trial portfolio by helping to develop successful regulatory strategies and submissions in support of clinical trials. In order to meet client expectations, it is necessary for our...

  • Analytical Chemistry Senior Advisor

    1 month ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Manufacturing Scientist

    3 weeks ago

    Indianapolis, United States Eli Lilly Full time

    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...

  • Director of manufacturing operations

    4 days ago

    Indiana, United States Catalyst Life Sciences Full time

    Catalyst is currently recruiting for an experienced Manufacturing Operations leader to join a diversified pharmaceutical manufacturer based in Indiana. While the role remains very technical in nature, the key is for the incumbent to be a respected leader with the ability to manage teams and a variety of various stakeholders on a daily basis. If you consider...

  • Manufacturing Scientist – API Manufacturing Process Support

    1 month ago

    Indianapolis, United States Eli Lilly and Company Full time

    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...

  • Manufacturing Scientist

    2 weeks ago

    Indianapolis, United States Eli Lilly Full time

    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...

  • Manufacturing Scientist

    4 weeks ago

    Indianapolis, United States Eli Lilly Full time

    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...

  • Controller

    4 weeks ago

    Indianapolis, Indiana, United States EnPower, Inc. Full time

    Job Description A business partner to facilitate and coordinate financial activities based on financial statements. This includes the production of periodic financial reports, maintenance of an adequate system of records, and a comprehensive set of controls and budgets designed to mitigate risk. Monitor allotments and expenditures to ensure proper funding...

  • Analytical Chemistry Research Advisor

    4 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Analytical Chemistry Research Advisor

    1 week ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Advisor - Process Chemistry (SMDD)

    4 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Scientific Director

    6 days ago

    Indianapolis, United States Eli Lilly and Company Full time

    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...

  • Analytical Chemistry Scientific Director

    2 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Sr. Manufacturing Engineer, Controls

    3 days ago

    Bloomington, Indiana, United States Cook Group Full time

    Overview: This is a Sr. level position requiring 5+ years of subject matter expert CONTROLS experience in Large and Small production equipment (ex:  Allen Bradley).   The goal of this position is to drive process improvement and increase manufacturing efficiency. Responsibilities: Define, identify, procure, and qualify new equipment for manufacturing...

  • Group Leader, Asphalt Chemistry

    4 weeks ago

    Indianapolis, United States The Heritage Group Full time

    Position Summary As Group Leader, Asphalt Chemistry, the primary responsibility will be to guide and oversee a team of laboratory employees encompassing various scientific or engineering fields related primarily to the asphalt industry. The role is crucial in offering ongoing technical guidance and leadership to the group members, enabling them to perform at...

  • Group Leader, Asphalt Chemistry

    3 weeks ago

    Indianapolis, United States The Heritage Group Full time

    Job DescriptionJob DescriptionPosition SummaryAs Group Leader, Asphalt Chemistry, the primary responsibility will be to guide and oversee a team of laboratory employees encompassing various scientific or engineering fields related primarily to the asphalt industry. The role is crucial in offering ongoing technical guidance and leadership to the group...

  • Group Leader, Asphalt Chemistry

    4 weeks ago

    Indianapolis, United States The Heritage Group Full time

    Position SummaryAs Group Leader, Asphalt Chemistry, the primary responsibility will be to guide and oversee a team of laboratory employees encompassing various scientific or engineering fields related primarily to the asphalt industry. The role is crucial in offering ongoing technical guidance and leadership to the group members, enabling them to perform at...

  • Manufacturing Engineer 2, Controls

    3 days ago

    Bloomington, Indiana, United States Cook Group Full time

    Overview: The primary purpose of this position is to provide technical support to Production and Manufacturing Engineering. In addition, drive process improvements to increase Manufacturing efficiency plus further develop manufacturing activities within the plant. Responsibilities: Define, identify, procure, and qualify new equipment for manufacturing...

  • Advisor-Quality Control

    4 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Advisor-Quality Control

    4 weeks ago

    Indianapolis, United States Eli Lilly and Company Full time

    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...