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Research Associate

2-4 years
Not Disclosed
10 Jan. 27, 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: Research Associate - API Process Development
Location: [Specify location]
Company: [Specify company name, if applicable]

Job Description:

We are seeking a highly skilled and detail-oriented Research Associate to join our API Process Development team. The ideal candidate should have prior experience in API (Active Pharmaceutical Ingredient) process development, with a solid understanding of API kilo lab and pilot plant operations. This role will involve developing, optimizing, and scaling up processes for the production of target compounds, from feasibility studies to validation, and ensuring the quality and efficiency of the processes.

Key Responsibilities:

  • Develop and optimize processes for the production of APIs, focusing on feasibility, optimization, assurance batches, validation, and critical process parameters.
  • Prepare and compile Process Development Reports and manage scale-up activities from lab to kilo lab.
  • Study and modify reaction/process conditions in accordance with Quality by Design (QbD) principles to ensure the successful production of target compounds.
  • Manage multiple reactions concurrently, ensuring efficient use of time to produce target compounds while investigating side reactions.
  • Conduct literature searches for specific target compounds, structures related to the target compounds, or to determine specific conditions for reactions and compounds.
  • Stay updated with the latest scientific literature and collaborate with colleagues to discuss new findings and improve processes.
  • Identify efficient and robust synthetic routes for the preparation of New Chemical Entities (NCEs) and APIs.
  • Interpret analytical data to drive experimental plans for synthetic processes.
  • Utilize scientific literature search tools such as SciFinder to gather relevant data and enhance research efforts.
  • Handle batches ranging from gram-scale to kilogram-scale production.
  • Record all experiments, observations, and relevant data accurately in laboratory notebooks.
  • Support the transfer of API and intermediate processes from the lab scale to the pilot plant and eventually to the production floor, ensuring successful scale-up.

Skills and Expertise:

  • Strong understanding of API process development, including scale-up from lab to pilot plant.
  • Familiarity with quality assurance practices, including process validation, critical process parameters, and quality attributes.
  • Experience in designing and optimizing synthetic routes for the preparation of APIs and NCEs.
  • Proficiency in analytical data interpretation to guide experimental plans.
  • Knowledge and practical experience with tools such as SciFinder for scientific literature search.
  • Ability to handle and scale-up batches from gram-scale to kilogram-scale.
  • Strong organizational and time management skills to handle multiple projects simultaneously.
  • Good communication skills and ability to collaborate with cross-functional teams.

Qualifications:

  • Education: Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or a related field.
  • Experience: Minimum 2-4 years of experience in API process development, preferably in a pharmaceutical or chemical industry setting.
  • Familiarity with API kilo lab/pilot plant operations and scale-up processes is required.

Proficiency Levels:

  • Functional Skills: Expertise in process development, scale-up, and API production.
  • Behavioral Skills: Working knowledge in scientific literature search, analytical data interpretation, and cross-functional collaboration.

If you are passionate about process development and have the necessary experience to contribute to the successful production of APIs, we encourage you to apply and join our dynamic team.