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Senior/Advisor - Formulation Scientist

4-7 years
Not Disclosed
10 Jan. 29, 2025
Job Description
Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior/Advisor - Formulation Scientist
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full-Time, Regular
Job ID: R-72993

Company Overview:
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, USA. Our 39,000 employees worldwide work to discover and bring life-changing medicines to those who need them, improve the understanding and management of diseases, and give back to our communities through philanthropy and volunteerism. We put people first and are looking for individuals who are determined to make a meaningful difference in the world.

Position Overview:
The Senior/Advisor Formulation Scientist is responsible for applying advanced experience in solid drug product manufacturing to accelerate the development of combination products and enhance manufacturability. This position requires strong technical expertise in formulation design, process development, and the ability to lead multidisciplinary teams. The individual will contribute to developing novel therapies and manage the transfer of processes into manufacturing.

Key Responsibilities:

  • Apply expertise in solid drug product manufacturing to accelerate the development of combination products and enhance manufacturability.
  • Conduct comprehensive material and manufacturing process risk assessments to aid formulation selection and development, as well as experimental work-plans.
  • Develop and define critical quality attributes (CQAs) to improve and design robust drug products.
  • Lead the implementation of advanced platforms such as continuous manufacturing, process analytical technologies (PAT), and modeling and simulation tools.
  • Design robust, globally acceptable manufacturing process control strategies and collaborate with manufacturing teams to transfer these strategies.
  • Lead both short-term and long-term development activities, ensuring prioritization of technical agendas and timelines.
  • Partner with multifunctional teams, including Product Delivery, Project Management, Quality, Manufacturing, and Regulatory, to execute and deliver materials and information for clinical trials and regulatory submissions.
  • Lead the development of regulatory strategies, including the authorship of INDs, NDAs, and responses to regulatory inquiries.
  • Demonstrate the ability to apply biopharmaceutical knowledge to novel challenges, accelerating drug product development.
  • Foster diverse thought and leverage external innovation to deliver creative solutions that meet unmet technical needs.
  • Engage and influence the external environment, adopting innovative approaches across Lilly’s drug product portfolio.

Minimum Qualifications:

  • Ph.D. in Chemical Engineering, Pharmaceutical Sciences, or a related field with 4-7 years of relevant experience, or a B.S. or M.S. with 10+ years of demonstrated equivalent experience in a related field.
  • Extensive experience in developing solid drug product formulations, manufacturing processes, and transferring these processes into manufacturing, particularly for complex combination products.
  • Strong understanding of new platforms such as PAT, modeling, and simulation tools.
  • Experience with modified release, peptide oral drug delivery landscapes is advantageous.
  • Demonstrated experience in managing technical projects.
  • Proven leadership capabilities, including the ability to supervise and guide others in a team environment.

Preferred Skills:

  • Familiarity with new platforms like PAT, modeling, and simulation tools.
  • Knowledge of modified release formulations and peptide oral drug delivery.
  • Strong management skills with experience in leading technical projects and teams.

Additional Information:

  • Location: Lilly Capability Centre India (LCCI), Bengaluru, India.
  • Some travel required for the role.
  • Competitive compensation and benefits.

Equal Opportunity Employer:
Lilly is dedicated to fostering an inclusive workplace and ensures equal opportunities for all individuals, regardless of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, disability, or any other legally protected status. We actively support the inclusion of individuals with disabilities in the workforce and encourage candidates to reach out for accommodations if necessary during the application process.

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