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Associate Director - Downstream Process Development & Manufacturing, CMC Biologics

Employer
Eli Lilly and Company
Location
Remote, Indiana
Start date
Jan 31, 2024

View more

Discipline
Engineering, Science/R&D, Biotechnology, CMC
Required Education
Bachelors Degree
Position Type
Full time

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.

Organization 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.

About Loxo@Lilly:

Loxo@Lilly aims to create medicines that make life better for all those affected by cancer around the world. Bringing together the focus and spirit of a biotech with the scale, resources, and heritage of Lilly, our team is focused on rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating oncology medicines that unequivocally show early signs of clinical activity and will matter to patients.  We intend to curate a balanced pipeline of medicines, either internally or externally discovered, with the potential to treat cancer with dramatic effect.  Loxo@Lilly was created in December 2019, combining the Lilly Oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019.  Loxo@Lilly is a global organization with team members in Louisville, Colorado; Indianapolis, Indiana; New York City, New York; San Diego, California; South San Francisco, California; Stamford, Connecticut; and Madrid, Spain.

Position Summary:

The CMC Biologics team has an exciting opportunity for an innovative individual to join our organization and develop the growing oncology portfolio of therapeutic proteins of various modalities (mAbs, bispecifics, antibody-drug conjugates, etc.).

The Associate Director, Downstream Process Development & Manufacturing, CMC Biologics will report to the Senior Director and assist with phase appropriate downstream development and manufacturing efforts including optimization, characterization, and validation of purification process for early-stage programs. In addition, this role will collaborate with cross-functional teams to drive process improvements, efficiency, and scalability.

Roles and Responsibilities of the Position:

  • Work in a team environment to help drive and manage various downstream development and manufacturing activities primarily at third-party partners.
  • Partner with colleagues in discovery, upstream process development and analytical to develop integrated clinical process and manufacturing solutions that achieve quality by design targets with robust control strategies.
  • Assist with the creation of the downstream development strategy and execution enabling consistent high-yielding, high-purity, and scalable downstream purification.
  • Provide technical and scientific direction to third-party partners.
  • Create written development instructions and work with third-party partners to perform desired experiments incorporating Quality by Design (QbD).
  • Prepare technical reports, data summaries and CMC related documents required for various regulatory submissions.
  • Collaborate with analytical team developing methods for characterization and early formulation screening.
  • Collaborate on product characterization/comparability and lot release studies.
  • Assist in non-GMP and GMP drug substance manufacturing activities at third-party partners.
  • Assist in non-GMP and GMP drug product fill/finish activities at third-party partners (as required).
  • Write and review sections in regulatory submission documents (e.g., IND, IMPD, BLA).
  • Key member of the interdisciplinary CMC project teams.

Basic Qualifications:

  • BS degree required. Prefer candidates with a Master’s and/or PhD.
  • Minimum of ten (10) years of experience working in a Biotech or Pharmaceutical FDA regulated industry or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained.

Additional Preferences:

  • Knowledge of structured methodologies for process design, scale-up/down models, process control strategies, and process validation.
  • Knowledgeable in chemical and physical characterization of biologic proteins and antibodies.
  • Knowledge of regulatory environment (ICH/FDA/EMA regulations) and experience with organizing and writing regulatory submissions.
  • Strong background in development of biologics (monoclonal antibodies preferred); additional experience with T-cell engagers and antibody-drug conjugates ideal.
  • Experience with the development of filtration and viral filtration processes.
  • Extensive experience with biologics drug substance manufacturing including strong scientific and technical experience within relevant manufacturing process technologies and unit operations.
  • Experience writing and presenting clearly on CMC topics.
  • Demonstrable ability to work proactively, independently, and tenaciously.
  • Ability to work in various time zones, i.e., attending Zoom meetings in both ET and PT time zones.

Lilly (Eli Lilly and Company) currently anticipates that the base salary for this position could range from between $111,000-162,800 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Loxo@Lilly (Eli Lilly and Company)  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).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo@Lilly (Eli Lilly and Company) reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Loxo@Lilly (Eli Lilly and Company) compensation practices and guidelines will apply regarding the details of any promotion or transfer of Loxo@Lilly (Eli Lilly and Company) employees.

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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