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Sr. Research Scientist

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]

Job Description:

We are looking for a highly motivated and detail-oriented Research Associate to join our API Process Development team. The ideal candidate will have experience in API (Active Pharmaceutical Ingredient) process development and a thorough understanding of kilo lab and pilot plant operations. This role involves developing, optimizing, and scaling up processes to produce target compounds, from initial feasibility studies through to validation, while ensuring the quality, efficiency, and consistency of the processes.

Key Responsibilities:

  • Develop and optimize processes for the production of APIs, including feasibility studies, optimization, assurance batches, validation, and identifying critical process parameters.
  • Prepare Process Development Reports and manage the scale-up of processes from the lab scale to kilo lab.
  • Modify reaction and process conditions in alignment with Quality by Design (QbD) principles to ensure successful production of target compounds.
  • Plan and run multiple reactions simultaneously to ensure efficient use of time and resources, prioritizing the production of target compounds.
  • Conduct literature searches to gather information on specific target compounds, related structures, and reaction conditions, staying updated with current scientific literature.
  • Identify and implement efficient and robust synthetic routes for the preparation of New Chemical Entities (NCEs) and APIs.
  • Interpret analytical data and use it to guide experimental plans for synthetic processes.
  • Utilize scientific tools such as SciFinder for literature searches to enhance experimental design and process development.
  • Handle production batches ranging from gram-scale to kilogram-scale.
  • Maintain accurate and detailed records of all experiments, observations, and data in laboratory notebooks.
  • Support the transfer of API processes and intermediates from laboratory-scale development to pilot plant and production scale, ensuring smooth scale-up.

Skills and Expertise:

  • Strong understanding of API process development, including scale-up from lab to pilot plant.
  • In-depth knowledge of quality assurance practices, including process validation, critical process parameters, and quality attributes.
  • Proven experience in designing and optimizing synthetic routes for APIs and NCEs.
  • Ability to interpret analytical data to guide process and experimental planning.
  • Proficient in utilizing scientific literature tools such as SciFinder for efficient literature searches.
  • Experience handling and scaling-up batches from gram-scale to kilogram-scale.
  • Excellent organizational and time-management skills, capable of managing multiple projects concurrently.
  • Strong communication and teamwork skills, with the ability to collaborate effectively with cross-functional teams.

Qualifications:

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

Proficiency Levels:

  • Functional Skills: Expertise in process development, scale-up, and API production.
  • Behavioral Skills: Solid working knowledge of scientific literature searches, analytical data interpretation, and collaborative problem-solving with cross-functional teams.

If you are passionate about advancing process development and have the expertise to contribute to the successful production of APIs, we invite you to apply and join our team.