Senior Manufacturing Science Lead - API Processes

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; Full time

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.

Job Description:

The Senior Scientist – Manufacturing Science provides the technical support required to achieve the reliable and compliant manufacture of the API External Manufacturing (API EM) portfolio which includes raw materials, intermediates, enzymes and bulk drug substances. The Senior Scientist – Manufacturing Science executes technical projects (experimental, modeling and/or production data analysis) to improve and optimize process control, yield, purity, and/or productivity. In addition, the Senior Scientist – Manufacturing Science 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 TS/MS laboratory.

Key Objectives/Deliverables:

• 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, 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 degree in scientific disciplines of Biochemistry, Organic Chemistry, Chemical Engineering, Physical Chemistry, Bioanalytical Chemistry, Analytical Chemistry.
• 3+ years of relevant industrial experience in any of the following discipline such as API Manufacturing, TS/MS, Quality Control, Quality Assurance, or Development.

• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences:

• Demonstrated basic knowledge in small 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.

Other Information:

• Complete learning plan for API EM TS/MS Scientist.

• No certifications required.

• 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

$66,000 - $171,600

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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