Scientist - Molecular Biology, Cell Culture Upstream Process Development

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 65,000 - 149,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Medical, dental, vision benefits

Well-being benefits

Job summary

Lilly in Indianapolis is seeking a scientist for upstream process development within BR&D, focusing on monoclonal antibodies and related bioproducts. The role involves cell line development, process definition, optimization and transfers to pilot and manufacturing sites.

The candidate will work with Discovery, Manufacturing and Quality teams, author regulatory sections, and ensure GMP/GLP compliance. A strong background in cell culture and recombinant protein expression is essential.

Qualifications

• BS/MS in Microbiology, Cell Biology, Molecular Biology, Biology, Chemical Engineer, or related field.
• BS with 6+ years or MS with 3+ years of relevant industrial experience; PhD not considered at this level.
• Experience designing experiments, generating data, interpreting results and documenting work.

Responsibilities

• Design and execute upstream development experiments for bioproduct active pharmaceutical ingredient.
• Provide hands-on support for troubleshooting and innovation projects.
• Collaborate with BR&D, Discovery and Manufacturing groups on process development.
• Support transfer of upstream processes to pilot plant and manufacturing sites.
• Author technical reports and regulatory documents.
• Work with external parties on development projects and outsourcing efforts.
• Ensure alignment with GMP, GLP, and regulatory requirements.

Skills

Experiment design

Data interpretation

Team collaboration

Regulatory documentation

Oral and written communication

Education

BS/MS in Microbiology/Cell Biology/ Molecular Biology/ Biology/ Chemical Engineering

Tools

Cell culture bioreactor operation

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 Bioproduct Research and Development (BR&D) organization strives to deliver innovative medicines to patients through the development and commercialization of monoclonal antibodies, novel therapeutic proteins, peptides, bioconjugates, cell therapies, gene therapies, and other genetic medicines etc. This organization is a multidisciplinary group that works collaboratively with our discovery, manufacturing and quality, business units.

The scientist is responsible for upstream process development activities related to the production of bioproduct active pharmaceutical ingredients including cell line development, cell culture process definition and optimization, process robustness studies, process transfers to pilot plant and manufacturing sites and authorship of upstream process development sections of regulatory submissions.The position will interact closely with other scientists in BR&D 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 support bioproduct process and product development activities.

Responsibilities

• Design and execute appropriate upstream development experiments for generation of bioproduct active pharmaceutical ingredient including protein intermediates for bioconjugation.
• Provide hands‑on support for troubleshooting technical issues and driving innovation projects with novel ideas and technologies.
• Participate in cross-functional process development teams and effectively collaborate with other groups in BR&D, Discovery, Technical services for Manufacturing and Manufacturing.
• Support transfer of upstream 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 needed to achieve short-term and long-term departmental goals.
• Keep current of relevant scientific literature, new technologies/capabilities and regulatory initiatives/requirements and support their implementation, as appropriate.
• Ensure work is aligned with all relevant Development Quality, Regulatory, HSE, GLP and GMP requirements.

Basic Requirements

• BS/MS in Microbiology, Cell Biology, Molecular Biology, Biology, Chemical Engineer, or related field
• BS with 6+ or MS with 3+ years of relevant industrial experience
• PhD will not be considered at this job level
• Experience with designing experiments, generating data, interpreting results, and documenting the work, independently.
• Knowledge of cell biology, cell culture, molecular biology with an emphasis on recombinant protein expression.
• Hands‑on experience with cell line generation, cell culture bioreactor operation skills.
• General knowledge and understanding of issues associated with scaling of upstream processes.
• Ability to work well in a team environment incorporating a variety of functional relationships and desire to be a point of accountability.
• Effective oral and written communication skills, self-management, task planning and organization.
• 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 Skills and Preferences

• Use of statistics for data analysis
• Data science and/or AI/ML experience
• Capable of solving problems with minimal supervision
• Work productively in an interdisciplinary 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.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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 $65,250 - $148,500

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.