Scientist – API Manufacturing Process Support

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

Job summary

A leading global healthcare company is seeking a Scientist for API Manufacturing Process Support in Indianapolis. The successful candidate will provide technical support to ensure compliant manufacture of active pharmaceutical ingredients, focusing on process optimization and research for improvements. Ideal candidates hold a STEM degree and have experience in cGMP manufacturing, alongside strong analytical and communication skills.

Benefits

Comprehensive benefits program

401(k) and pension plan

Flexible spending accounts

Employee assistance programs

Qualifications

• Minimum 3 years of experience in cGMP manufacturing for Bachelor's.
• At least 1 year experience in cGMP manufacturing for Master's.
• Relevant experience in API manufacturing, Technical Services, Quality Control, etc.

Responsibilities

• Execute technical projects to improve process control, yield, and productivity.
• Provide technical support for process documentation and validation.
• Independently set up and execute chemical reactions.

Skills

Analytical skills

Interpersonal skills

Communication skills

Problem-solving skills

Project management

Education

Bachelor's in STEM Discipline (Chemistry preferred)

Master's Degree in relevant field

Job description

Scientist – API Manufacturing Process Support

Join to apply for the Scientist – API Manufacturing Process Support role at BioSpace

Scientist – API Manufacturing Process Support

6 days ago Be among the first 25 applicants

Join to apply for the Scientist – API Manufacturing Process Support 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.

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 save 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 (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.

#WeAreLilly

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Internet News

Referrals increase your chances of interviewing at BioSpace by 2x

Sign in to set job alerts for “Manufacturing Scientist” roles.

Urgent Opening - Lab Technician (BioChemistry) onsite Indianapolis, IN

Indianapolis, IN $20.00-$24.00 12 hours ago

Director/Senior Director - Manufacturing Science

Scientist – API Manufacturing Process Support

QC Laboratory Instrumentation Specialist

Laboratory Technician - Biochemistry/Chemistry/Biology/Related Science Field

Manufacturing Engineer - CMC CVI Process

Indianapolis, IN $70,629.00-$105,943.00 1 day ago

Technical Services Manufacturing Scientist

QC Laboratory Instrumentation Specialist

Indianapolis, IN $63,000.00-$162,800.00 1 week ago

Indianapolis, IN $22.00-$23.00 3 weeks ago

Formulations Lab Technician-Study Tech Dose Formulations

Sr. Scientist TS/MS - Parenteral Manufacturing

QA Device - Commissioning and Qualification

Indianapolis, IN $63,000.00-$162,800.00 6 days ago

Indianapolis, IN $81,200.00-$150,800.00 6 days ago

Senior Advisor/Director - Manufacturing Science

Indianapolis, IN $20.00-$25.00 5 hours ago

Principal Associate - QA (Clinical External Manufacturing)

Director/Senior Director - Manufacturing Science

Indianapolis, IN $141,000.00-$246,400.00 2 days ago

Indianapolis, IN $76,500.00-$167,200.00 2 weeks ago

Indianapolis, IN $52,100.00-$69,500.00 2 hours ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.