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Associate Scientist

3-7 years
Not Disclosed
10 Jan. 29, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,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: Associate Scientist – Analytical Development (Oral Solids)

Date: 20 Jan 2025
Location: Bangalore
Pay Grade: 
Years of Experience: 3–7 years

About Syngene

Syngene International is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene, safety is a core priority, and the company upholds a culture of integrity, quality, and compliance. All employees are expected to adhere to safety guidelines, procedures, and standard operating protocols (SOPs).

Core Purpose of the Role

The Associate Scientist – Analytical Development (Oral Solids) is responsible for providing analytical support to formulation development through routine sample analysis, method development, instrument calibration, documentation, and report preparation. The role requires expertise in analytical techniques, regulatory compliance, and scientific documentation.

Key Responsibilities

Analytical Method Development & Testing

  • Perform routine analysis of samples related to oral solid dosage forms.
  • Develop and validate analytical methods for various tests, including:
    • Assay
    • Degradation products
    • Dissolution (I, II & IV)
    • Blend uniformity
    • Content uniformity
    • Cleaning method validation
  • Ensure compliance with regulatory guidelines for method development and product testing.
  • Conduct instrument calibrations and troubleshooting for analytical instruments.

Instrument Handling & Maintenance

  • Operate and maintain analytical instruments, including:
    • KF Auto Titrator
    • Dissolution Apparatus (I, II & IV)
    • UV Spectrophotometer, IR Spectrometer
    • High-Performance Liquid Chromatography (HPLC)
    • Gas Chromatography (GC)
    • LC-MS, GC-MS (preferred but not mandatory)
  • Ensure instruments are in calibrated and validated states.

Documentation & Compliance

  • Prepare method development reports, including Assay, Degradation Products, Dissolution, and Cleaning Method Validation.
  • Maintain online lab notebooks and ensure compliance with Good Documentation Practices (GDP).
  • Prepare and review:
    • Method of Analysis (MOA)
    • Test Reports
    • Standard Operating Procedures (SOPs)
    • Calibration Documentation
  • Review documents generated by peers or junior scientists.
  • Conduct scientific literature searches to support analytical method development.

Collaboration & Teamwork

  • Work collaboratively with formulation scientists and analytical teams.
  • Provide technical coaching and mentorship to junior team members.
  • Participate in cross-functional discussions related to product development and analytical strategy.

Role Accountabilities

  • Ensure error-free analysis and documentation.
  • Maintain regulatory compliance and laboratory safety standards.
  • Support timely completion of projects and contribute to formulation development.
  • Ensure audit readiness by maintaining accurate and complete records.

Skills & Competencies

Technical Skills

  • Strong theoretical and practical knowledge of analytical chemistry.
  • Proficiency in analytical method development and validation.
  • Experience with analytical instrumentation and troubleshooting.
  • Familiarity with regulatory guidelines related to method development and product testing.
  • Proficiency in MS Office tools for documentation and reporting.
  • Ability to conduct scientific literature searches and apply findings to method development.

Behavioral Skills

  • Strong commitment to work with a high level of dedication, enthusiasm, and motivation.
  • Excellent speaking, listening, and writing skills.
  • Attention to detail and ability to work in a dynamic environment.
  • Strong problem-solving skills with a proactive mindset.
  • Ability to meet tight deadlines and manage multiple priorities.
  • Strong team player with a willingness to work in shifts.

Education & Experience

  • Education: M.Pharm / M.Sc. in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
  • Experience: 3–7 years of experience in analytical development for oral solid dosage forms.

Syngene Core Values

All employees are expected to demonstrate alignment with Syngene’s core values:

  • Excellence
  • Integrity
  • Professionalism

Equal Opportunity Employer

Syngene is an equal opportunity employer, committed to providing a diverse and inclusive workplace. The company complies with all applicable non-discrimination laws and provides reasonable accommodations for qualified individuals with disabilities.