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Advisor - Upstream Process Development - Akouos

Employer
Eli Lilly and Company
Location
Boston, Massachusetts
Start date
Nov 5, 2023

View more

Discipline
Engineering, Manufacturing & Production, Process
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details

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.

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.

Akouos is building a leading gene therapy company focused on hearing disorders. We are a precision genetic medicine company dedicated to developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals living with disabling hearing loss worldwide.

Restoring, improving, and preserving high-acuity hearing is an area of high unmet need in medicine: 466 million people worldwide have disabling hearing loss, and there are no FDA-approved therapies to address its underlying causes.

Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy. Listening is in our DNA. We believe the only way to achieve our ambitious goals is to engage as one team, listen to each other, and trust in ourselves and our science.

Job Summary

The Process Development group at Akouos is seeking an innovative scientist to provide hands-on development support for the manufacturing of AAV-based gene therapy vectors. Experiences in molecular biology, cell line development and plasmid production are highly preferred. The successful candidate will actively participate in upstream process development, scale-up, process optimization, and process tech transfer for GMP manufacturing. The successful candidate will thrive in a collaborative, scientifically stimulating, and fast-pace work environment.

Responsibilities

We are looking for someone who will:

  • Devise and execute AAV upstream process development studies to support early pipeline and GMP clinical phase AAV programs
  • Evaluated various production platform, including inducible producer cell line to enhance rAAV productivity.
  • Drive the design and execution of experimental studies needed to support identification of critical process parameters, operating ranges and process improvements.
  • Draft and review documentation such as study protocols and reports, regulatory sections to support INDs as well as draft manufacturing batch records for internal pilot and external GMP downstream operations
  • Actively participate and manage tech-transfer activities to CMOs and internal pilot scale manufacturing
  • Generate, manage, evaluate, and maintain critical data in a highly organized manner and document in paper or Electronic Laboratory notebook
  • Work with external and internal manufacturing partners as downstream subject matter expert for manufacturing campaigns

Basic Qualifications

  • B.S in Biochemistry, Chemical Engineering, Bioengineering or related discipline and 15+ years of relevant experience, or M.S and 12+ years of relevant experience, or PhD with 0 - 2+ years of relevant experience.

Additional Skills/Preferences

  • Hands-on experience in aseptic techniques and executing vector design, plasmid production, cell line development, cell banking, and process development activities.
  • Demonstrated experience developing harvest, filtration, TFF and other drug substance unit operation techniques to support a cGMP compliant process
  • Proven ability to work independently, effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines
  • Prior experience in AAV HEK and/or Baculovirus suspension based process development is strongly preferred
  • Experience in IND-enabling documentation and tech transfer is highly desirable.
  • Experience with design and execution of DOE (JMP) studies is preferred

Additional Information

  • This position requires work on site at the Akouos facility located in Seaport Boston
  • Occasional travel to CMO sites (<10%)

Akouos is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly

Company

Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. 

Company info
Location
893 S Delaware St
Indianapolis
Indiana
46285
United States

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