Instagram
youtube
Facebook

Formulation Scientist

5+ years
Not Disclosed
10 Jan. 3, 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

Title: Formulation Scientist
Location: S18, Syngene, Bengaluru
Department: Formulation Development Centre (FDC)
Date: 3 Jan 2025

About Syngene:

Syngene (www.syngeneintl.com) is an innovation-driven contract research, development, and manufacturing organization providing integrated scientific services from early discovery to commercial supply. At Syngene, safety is central to everything we do, both personally and professionally, with a strong focus on adhering to safety guidelines, procedures, and SOPs.

Mandatory Expectations:

  • Adhere to safety guidelines and practices in all activities and ensure compliance with the company's quality and integrity standards.
  • Drive a culture of environmental, health, and safety (EHS) practices across teams.
  • Ensure the completion of all mandatory safety and data integrity training on time.

Core Purpose of the Role:

As a Formulation Scientist, you will lead the development of parenteral drug products, including pre-formulation, formulation design, process optimization, and technology transfer from R&D to manufacturing sites. This role will involve close coordination with production and quality teams to support drug product manufacturing in GMP fill-finish facilities and ensure smooth transitions of lab processes to GMP standards.

Role Accountabilities:

  • Accountable for achieving client milestones and meeting compliance expectations.
  • Lead the development and optimization of parenteral drug products, ensuring efficient process transfer to GMP manufacturing sites.

Leadership Capabilities:

  • Self-Driven and Self-Motivated with strong communication and coordination skills.
  • Proven ability to manage cross-functional teams effectively.

Experience:

  • Minimum of 5 years of industrial research experience in formulation development and technology transfer of parenteral drug products (small and large molecules).

Skills & Capabilities:

  1. Formulation Expertise: Strong experience in parenteral drug product development, process optimization, and technology transfer across early to late-phase stages, including commercialization.
  2. Process Development Leadership: Proven experience in leading technology transfer processes to GMP sites, ensuring product quality, compliance, and scale-up success.
  3. Troubleshooting & Optimization: Expertise in resolving challenges during scale-up, clinical, and registration batch production.
  4. Regulatory & Compliance Knowledge: Experience with GMP documents (BMR, BPR, PPQP) and managing deviations, CAPA, and QMS activities.
  5. Cross-Functional Coordination: Ability to manage internal and external stakeholders, including working with third-party manufacturers and coordinating client audits.

Education:

  • Master of Pharmacy (Pharmaceutics, Industrial Pharmacy, or Process Technology).

Equal Opportunity Employer:

Syngene is committed to equal employment opportunities and providing reasonable accommodations for individuals with disabilities.