Advisor/Sr. Advisor Formulation Development

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 152,000 - 244,000; Full time

Benefits offered by this job

Company bonus

Comprehensive benefits

In-office/lab attendance

Job summary

Lilly in Indianapolis is seeking a highly motivated Scientist to join the Bioproduct Research and Development group, focusing on parenteral formulations of large and small molecules and novel modalities. The organization emphasizes development of genetic medicines and advanced drug delivery platforms.

You will lead hands-on formulation studies, build scalable processes, and collaborate across disciplines to support clinical development and tech transfer to manufacturing, contributing to

Qualifications

• Earned Bachelors degree OR Master's degree in Pharmaceutics or Pharmaceutical Sciences, Biochemistry, Chemical Engineering or a related field
• 10+ years of pharmaceutical or biotech industry experience
• Prior experience developing processes and understanding basic principles and analytical techniques necessary to characterize large molecules or biological materials
• Knowledge and understanding of parenteral drug formulation development, parenteral manufacturing and aseptic technologies, and/or drug product process development
• Ability and desire to communicate and work cross-functionally within the team and with other teams on a consistent basis.

Responsibilities

• Represent Drug Product team in CM&C teams and support the formulation and process development of protein, peptide, oligonucleotides and other novel modalities in clinical development
• Hands‑on experimental activities in formulation group to support clinical development of parenteral drug products and other complex formulations
• Build process capabilities for lab scale, early phase clinical scale, and scale up technologies for parenteral drug product and other complex formulations
• Support tech transfer of process and formulation to clinical manufacturing sites.
• Work closely with synthetic chemistry, toxicology, ADME groups, analytical teams and device teams to develop the drug product that is stable and patient centric.
• May need to support monoclonal antibody, proteins and peptide programs in various stages of development.
• Provide technical support in the areas of formulation and drug delivery.
• Partner with key teams such as discovery, and drug product delivery and device to develop innovative solutions with a patient focus in an integrated fashion.
• Collaborate with Discovery teams on establishing systems for seamless handoff of assets from discovery to clinical development.
• Innovate or assess cutting edge formulation methodologies for complex or unstable bioproducts (peptides, proteins, fusion proteins and drug conjugates)
• Identify and spearhead research efforts on understanding new drug delivery technologies in the areas of targeted drug delivery and other novel drug delivery fields, and establish proof of concept for technologies for appropriate assets under development
• Establish and leverage strategic relationships with academia and start-ups to accelerate and access emerging innovation.
• Drive a strong innovation agenda for the team leading to publications, presentations and industry wide influence
• Ability to wear multiple functional hats so that input into various complementary parts of the project can be managed in a rapid and localized manner

Education

Bachelor's or Master's degree in Pharmaceutics or Pharmaceutical Sciences, Biochemistry, Chemical Engineering or related field

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.

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 Lilly Bioproduct Research and Development (BR&D) organization is focused on the development and commercialization of parenteral formulations of small molecules and large molecules such as monoclonal antibodies, novel therapeutic proteins and peptides. The organization is also committed to the development of genetic medicines which includes active investments in Oligonucleotide development, nanomedicines for tissue specific targeting and other gene delivery strategies. The drug product team is also investing in building new platforms to support complex formulations such as lipid nanoparticles, Antibody Drug Conjugates and AAV and other non-viral vector delivery.

We are seeking a highly motivated Scientist with an interest or experience in developing parenteral drug product through various stages of clinical development. If you are interested in building platforms for new and novel therapeutic modalities and interested in exploring new frontiers into formulation and drug delivery strategies, you should consider joining our diverse team.

Responsibilities:

• Represent Drug Product team in CM&C teams and support the formulation and process development of protein, peptide, oligonucleotides and other novel modalities in clinical development
• Hands‑on experimental activities in formulation group to support clinical development of parenteral drug products and other complex formulations
• Build process capabilities for lab scale, early phase clinical scale, and scale up technologies for parenteral drug product and other complex formulations
• Support tech transfer of process and formulation to clinical manufacturing sites.
• Work closely with synthetic chemistry, toxicology, ADME groups, analytical teams and device teams to develop the drug product that is stable and patient centric.
• May need to support monoclonal antibody, proteins and peptide programs in various stages of development.
• Provide technical support in the areas of formulation and drug delivery.
• Partner with key teams such as discovery, and drug product delivery and device to develop innovative solutions with a patient focus in an integrated fashion.
• Collaborate with Discovery teams on establishing systems for seamless handoff of assets from discovery to clinical development.
• Innovate or assess cutting edge formulation methodologies for complex or unstable bioproducts (peptides, proteins, fusion proteins and drug conjugates)
• Identify and spearhead research efforts on understanding new drug delivery technologies in the areas of targeted drug delivery and other novel drug delivery fields, and establish proof of concept for technologies for appropriate assets under development
• Establish and leverage strategic relationships with academia and start-ups to accelerate and access emerging innovation.
• Drive a strong innovation agenda for the team leading to publications, presentations and industry wide influence
• Ability to wear multiple functional hats so that input into various complementary parts of the project can be managed in a rapid and localized manner

Basic Requirements:

• Earned Bachelors degree OR Master's degree in Pharmaceutics or Pharmaceutical Sciences, Biochemistry, Chemical Engineering or a related field
• 10+ years of pharmaceutical or biotech industry experience
• Prior experience developing processes and understanding basic principles and analytical techniques necessary to characterize large molecules or biological materials
• Knowledge and understanding of parenteral drug formulation development, parenteral manufacturing and aseptic technologies, and/or drug product process development
• Ability and desire to communicate and work cross-functionally within the team and with other teams on a consistent basis.

Additional Preferences:

• Earned PhD in a relevant field with up to 5 years of industry experience.
• Background encompasses both innovation and technical development of oligos, protein, peptide, viral or cell therapeutics as evidenced by a history of publications.
• Knowledge and hands on experience on the lab automation and high throughput formulation screen is a plus

Additional Information:

• Location: Indianapolis, IN. This position requires in-office/lab attendance daily, and does not allow for hybrid/remote work.
• The work environment is in a Laboratory.

  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.

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).

$151,500 - $244,200

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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