Scientist, Bioprocess Purification Development

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 80,000 - 117,000; Full time

Job summary

Lilly, headquartered in Indianapolis, Indiana, is seeking a scientist to advance downstream purification development for bioproducts. The role involves defining purification processes, transferring methods to pilot plants and manufacturing sites, and drafting regulatorydocumentation.

Collaboration with Bioprocess/Bioproduct Development and Manufacturing teams is essential. The candidate will contribute to process robustness studies, technology transfer, and regulatory submissions, while

Qualifications

• BS or MS degree in Chemical Engineering, Biochemistry, Chemistry or related field with 5+ years (BS) or 2+ years (MS) of direct related industry experience.
• PhD will not be considered at this job level.
• Biochemistry experience with some knowledge of protein chemistry and protein purification.

Responsibilities

• Design, execute and interpret appropriate purification development experiments for generation of bioproduct active pharmaceutical ingredient.
• Participate in cross-functional process development teams and effectively collaborate with other groups in Bioprocess and Bioproduct Development, Discovery, Technical services for Manufacturing and Manufacturing.
• Support transfer of purification processes to pilot plant and manufacturing sites.
• Author technical reports and regulatory documents.
• Work effectively with external parties on development projects, research collaborations and outsourcing efforts.
• Support organizational initiatives, as appropriate
• Keep abreast of relevant scientific literature, new technologies/capabilities and regulatory initiatives/requirements and support their implementation, as appropriate.
• Supervision of personnel and coaching, training and administration of performance management to personnel, where assigned.
• Ensure work is aligned with all relevant Development Quality, Regulatory, HSE, GLP and GMP requirements.

Skills

Bioprocess development

Purification development

Regulatory documentation

Team collaboration

DOE experience

Education

BS/MS in Chemical Engineering, Biochemistry, Chemistry or related

MS/BS with required experience

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Summary

The scientist is responsible for downstream purification development activities related to the production of bioproduct active pharmaceutical ingredients including purification process definition and optimization, process robustness studies, process transfers to pilot plant and manufacturing sites and authorship of downstream process development sections of regulatory submissions. The incumbent will interact closely with other scientists in Bioprocess/Bioproduct Development as well as Discovery, Technical services for Manufacturing, and Manufacturing scientists. They are expected to be an integral participant on multidisciplinary CMC project teams that provide support for bioproduct process and product development activities.

Responsibilities

• Design, execute and interpret appropriate purification development experiments for generation of bioproduct active pharmaceutical ingredient.
• Participate in cross-functional process development teams and effectively collaborate with other groups in Bioprocess and Bioproduct Development, Discovery, Technical services for Manufacturing and Manufacturing.
• Support transfer of purification processes to pilot plant and manufacturing sites.
• Author technical reports and regulatory documents.
• Work effectively with external parties on development projects, research collaborations and outsourcing efforts.
• Support organizational initiatives, as appropriate
• Keep abreast of relevant scientific literature, new technologies/capabilities and regulatory initiatives/requirements and support their implementation, as appropriate.
• Supervision of personnel and coaching, training and administration of performance management to personnel, where assigned.
• Ensure work is aligned with all relevant Development Quality, Regulatory, HSE, GLP and GMP requirements.

Basic Requirements

• BS or MS degree in Chemical Engineering, Biochemistry, Chemistry or related field with 5+ years (BS) or 2+ years (MS) of direct related industry experience.
• PhD will not be considered at this job level.
• Biochemistry experience with some knowledge of protein chemistry and protein purification
• 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

• Capable of independently designing experiments (experience with use of statistical design of experiments (DOE) is desirable), generating data, interpreting results and documenting work in laboratory notebooks and technical reports.
• Effective oral and written communication skills, self-management, task planning and organization.
• Must be able to work productively in a multidisciplinary team environment.

Additional Information

Physical Demands/Travel

The physical demands of this job are consistent with a lab environment.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position's work environment is in a laboratory environment.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$79,500 - $116,600

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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