Research Advisor, Drug Product - SMDD

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 126,000 - 204,600; Full time

Benefits offered by this job

Company-sponsored 401(k)

Medical, dental, and vision benefits

Flexible benefits programs

Job summary

Initial Therapeutics, Inc. is looking for a candidate for the pharmaceutical product development role in Indianapolis, IN. The position focuses on the design and optimization of drug products from preclinical to commercialization stages. Candidates should have a Ph.D. in Pharmaceutical Sciences and up to 5 years of relevant experience.

This role involves collaboration, technical report writing, and innovation in drug delivery systems. Lilly offers comprehensive benefit programs including bonuses, 401(k), and medical coverage.

Qualifications

• 0-5 years of demonstrated experience in pharmaceutical product development.
• Experience in drug product manufacturing unit operations.
• Basic understanding of regulatory/GMP aspects.

Responsibilities

• Design and optimize phase appropriate drug products.
• Predict in vivo performance of drug formulations.
• Collaborate with key partners to manage development activities.

Skills

Pharmaceutical product development

Solid-state forms understanding

Process analytical technology (PAT)

Continuous manufacturing knowledge

Regulatory/GMP understanding

Education

Ph.D. in Pharmaceutical Sciences or related field

Tools

Modeling and simulation tools

Data analytics

Job description

Position Brand Description

The Synthetic Molecule Design and Development (SMDD) department within Lilly Research Labs is involved in key activities for the advancement of small molecules, peptides, and oligonucleotides from early discovery phases to commercialization. Our scientists and engineers develop innovative technical and business solutions across a portfolio of projects using their deep technical expertise to accelerate testing of the clinical hypothesis and overall drug development. Through recognizing the value of a hardworking, diverse, and inclusive workforce, SMDD delivers on these responsibilities and helps bring the next generation of life changing medicines to patients. Our team is looking for highly motivated and creative candidates who will work on the integration of early drug discovery, preclinical, and clinical activities with a focus on drug product design and development.

Responsibilities

• Apply drug delivery fundamentals towards designing and optimizing phase appropriate drug products and processes from pre-FHD through commercialization for synthetic molecules.
• Predict and assess the in vivo performance of drug molecules and formulations in preclinical species and humans using molecular properties and preclinical data. Leverage modeling to guide the development of preclinical and clinical formulations to enable the delivery of a broad range of synthetic molecules.
• Refine clinical drug product prototypes, identify and mitigate technical risks to enable commercial products.
• Collaborate and communicate project specific challenges and opportunities with key partners to plan and manage short/long term development activities aligned with the global CMC strategy.
• Engage and influence internal and external scientific communities. Develop collaborations to solve technical challenges, identify and implement novel drug delivery and manufacturing technologies, influence clinical study design to benefit our patients.
• Author and review high quality technical reports, peer reviewed publications, and regulatory documentation to support new technologies and/or regulatory submissions.

Basic Requirements

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Material Science, or other related fields with 0-5 years of demonstrated experience in pharmaceutical product development.

Additional Skills/Preferences

• General understanding of solid-state forms, screening, and instrumentation used in characterizing physical properties of pharmaceutical solids. Experience in developing the relationship of these properties to product quality, performance attributes, and process development.
• Experience in technical considerations for equipment design and integration, process monitoring, integration of process analytical technology (PAT) systems, and scientific approaches on control strategies. Involvement with modeling and simulation tools, data analytics and predictive analytics.
• Experience in design, development, control, and optimization of drug product manufacturing unit operations, especially knowledge in continuous manufacturing within the pharmaceutical industry.
• Experience supervising or guiding the work of other scientists.
• Basic understanding of regulatory/GMP aspects pertaining to development and clinical testing of drug products.

Additional Information

• Possible exposure to chemicals, allergens, and loud noises.
• Travel: 0 to 10%
• Position Local: Onsite Monday through Friday, Indianapolis, IN; Lilly Technology Center-North (LTC-N)

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.

$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.