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Senior/ Advisor - Formulation Scientist

8-10 years
Not Disclosed
10 Feb. 11, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Description & Responsibilities:

As a Senior/Advisor Formulation Scientist, you will apply your experience in solid drug product manufacturing to accelerate the development of combination products and improve manufacturability. You will play a key role in shaping the product design, managing risks, and implementing advanced manufacturing techniques.

Key Responsibilities:

  • Manufacturing and Development: Leverage experience in solid drug product manufacturing to improve product development for combination products.
  • Risk Assessments: Conduct comprehensive material and manufacturing process risk assessments to guide formulation selection and development.
  • Critical Quality Attributes (CQAs): Define and improve the drug product design by identifying critical quality attributes (CQAs).
  • Platform Implementation: Drive the implementation of new platforms like continuous manufacturing, Process Analytical Technologies (PAT), and simulation tools.
  • Process Control Strategies: Design and implement robust manufacturing process control strategies, collaborating with manufacturing teams for seamless transfer.
  • Project Leadership: Lead and prioritize short- and long-term development activities, ensuring timelines and technical agendas are met.
  • Cross-functional Collaboration: Partner with teams like Product Delivery, Project Management, Quality, Manufacturing, and Regulatory to provide material and information for clinical trials and regulatory submissions.
  • Regulatory Strategies: Lead the development of regulatory strategies, including the creation of INDs, NDAs, and responses to regulatory inquiries.
  • Innovation and Agility: Apply biopharmaceutics knowledge to novel problems and embrace diverse perspectives to find creative solutions to technical challenges.
  • External Engagement: Influence and engage with external environments and incorporate external innovations into Lilly’s drug product portfolio.

Minimum Qualifications:

  • Education: Ph.D. in Chemical Engineering, Pharmaceutical Sciences, or a related field (4-7 years of experience) or B.S./M.S. (10+ years of demonstrated experience in the related field).
  • Experience: Significant experience in developing solid drug product formulations, manufacturing processes, and technical transfer, with an emphasis on complex combination products.

Additional Skills/Preferences:

  • Familiarity with new platforms such as PAT, modeling, and simulation tools.
  • Awareness of the landscape for non-standard oral drug delivery (e.g., modified release, peptide).
  • Strong project management experience and leadership capabilities.
  • Demonstrated leadership in team environments and experience in guiding the work of others.

Additional Information:

  • Position: LCCI
  • Travel: Some travel may be necessary.

Equal Opportunity Statement:

Lilly is committed to fostering an inclusive workforce and ensuring equal opportunities for individuals with disabilities. If you need accommodations to submit your resume, please complete the accommodation request form.

Lilly 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.

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