Scientist - API Manufacturing Process Support

Hispanic Alliance for Career Enhancement; Indianapolis (IN); On-site; USD 64,000 - 168,000; Full time

Job summary

An established industry player is seeking a Manufacturing Scientist to enhance the production of Active Pharmaceutical Ingredients. In this role, you will lead technical projects aimed at optimizing process control and ensuring compliance with industry standards. Your expertise will be crucial in executing experiments, analyzing data, and preparing essential technical documentation. This position offers a unique opportunity to contribute to life-changing medicines while working in a collaborative and innovative environment. If you are passionate about science and eager to make a difference, this role is perfect for you.

Qualifications

• 3+ years of experience in cGMP manufacturing or 1 year with a Master's Degree.
• Familiarity with API Manufacturing and quality assurance processes.

Responsibilities

• Execute technical projects to improve manufacturing processes and productivity.
• Provide technical support for documentation and regulatory submissions.

Skills

Analytical Skills

Interpersonal Skills

Written Communication

Oral Communication

Problem Solving

Education

Bachelor's in STEM Discipline

Master's Degree

Tools

cGMP Manufacturing

Technical Documentation

Job description

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.

The Manufacturing Scientist provides the technical support required to achieve the reliable and compliant manufacture of the Active Pharmaceutical Ingredient External Manufacturing (API EM) portfolio which includes raw materials, intermediates, enzymes and bulk drug substances. The API EM Manufacturing Scientist executes technical projects (experimental, modeling and/or production data analysis) to improve and optimize process control, yield, purity, and/or productivity. In addition, the manufacturing scientist should be capable and technically independent in setting up and executing a variety of experiments at the laboratory scale and conduct research on manufactured product for process improvements and troubleshooting in the technical services and manufacturing sciences laboratory.

Responsibilities:

• Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment.
• Execute technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity.
• Provide technical support for preparation of relevant technical documents, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs (Process Flow Documents), VMPs, etc.
• Develop and monitor established metrics in real-time to assess process variability and capability.
• Understand, justify and document the state of validation (process and cleaning) with data that evaluate the capability of the manufacturing process to meet its stated purpose.
• Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
• Provide support internal and joint process teams and to the global and local PLOT teams.
• Ability to independently set up and execute various chemical reactions.
• Ensure that experiments are well designed with clear objectives.
• Ability to analyze data and ensure appropriate documentation.
• Utilize safe laboratory practice and adhere to CHP requirements.
• Write technical reports and documents.

Basic Requirements:

• Bachelors in STEM Discipline (Chemistry focus preferred) and at least 3 years of experience in cGMP manufacturing.

or

• Master's Degree and 1 year experience in cGMP manufacturing.

Additional Preferences:

• Relevant industrial experience in any of the following discipline such as API Manufacturing, TS/MS (Technical Services/ Manufacturing Sciences), Quality Control, Quality Assurance, or Development.
• Demonstrated basic knowledge in small or large molecule API Manufacturing.
• Familiarity with cGMP manufacturing environment and terminology.
• 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.

Additional Information:

• 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 (here) for further assistance.

Lilly is an EEO/Affirmative Action Employer and 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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