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.
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.
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 Advisor/Sr. Advisor 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, execute and interpret appropriate upstream development experiments for generation of bioproduct active pharmaceutical ingredients including protein intermediates for bioconjugation.
- Provide support including hands-on experiments 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 cell culture 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.
- Engage externally through conference attendance, presentations and publications. Identify, partner, and develop process innovations from the outside to complement existing capabilities and areas of focus and incorporate these across the portfolio.
- Ensure work is aligned with all relevant Development Quality, Regulatory, HSE, GLP and GMP requirements.
- Provide technical leadership, guidance, mentorship of junior scientists.
Basic Requirements:
- PhD in Microbiology, Cell Biology, Molecular Biology, Biology, Chemical Engineer, or related field, or BS with >12 years, or MS with >8 years of relevant industrial experience.
- Knowledge of cell biology, cell culture, molecular biology with an emphasis on recombinant protein expression.
- General knowledge and understanding of the scaling of upstream processes, and potential issues and mitigation strategies.
- Extensive experience with designing experiments, generating data, interpreting results, and documenting the work independently.
- 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.
**Additional Preferences: **
- Solid molecular biology background, including understanding of cell line development, gene expression, and vector design is a plus.
- Hands-on experience with cell line generation, fed-batch and/or perfusion cell culture processes, bioreactor control strategies, and process parameter optimization.
- Experience with integrating automation and AI tools to enhance process development and data management is a plus.
- Demonstrated strong problem-solving and decision-making skills.
- 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 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
$126,000 - $204,600
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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