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Formulator

4+ years
Not Disclosed
10 Dec. 31, 2024
Job Description
Job Type: Full Time Education: M.Pharm 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 Description

Division:

IPD

Department:

IPD

Employment Type:

Permanent


Job Purpose

Responsible for executing end-to-end formula and process development of pharmaceutical products. This involves adhering to good laboratory practices (GLP), continuously monitoring data and quality to ensure robust product development within defined budgets, timelines, and regulatory standards.


Key Accountabilities

  1. Research and Literature Review:

    • Analyze and review pharmaceutical literature, including USFDA guidelines, to incorporate insights into product development.
  2. Documentation and Process Execution:

    • Prepare and submit stage-gate documents to cross-functional teams (CFT) based on development trial data.
    • Facilitate the smooth execution of manufacturing batches at the plant.
  3. Pre-Formulation Studies:

    • Conduct in-depth characterization of reference products.
    • Optimize formulas to create robust, high-quality products.
  4. Material Procurement:

    • Coordinate with the supply chain to procure filters, raw materials (RM), and packaging materials (PM) required for development and submission batches.
  5. Regulatory Submission:

    • Conduct R&D trials and execute submission batches at manufacturing units.
    • Compile and prepare data for regulatory filings to ensure successful approvals.
  6. Deficiency Resolution:

    • Provide technical support by generating required data from R&D or the manufacturing unit to address deficiencies during the approval process.

Educational Qualifications

  • Master’s degree in Pharmacy (Specialization in Pharmaceutics).

Relevant Experience

  • Minimum 4 years of experience in pharmaceutical R&D (preferably in injectables).

Competencies and Skills

  1. Core Competencies:

    • Strong expertise in pharmaceutical formulation and process development.
    • In-depth knowledge of pre-formulation and regulatory submission processes.
    • Familiarity with injectables development and R&D protocols.
  2. Behavioral Competencies:

    • Collaborate to Succeed: Effectively coordinate with cross-functional teams to achieve objectives.
    • Innovate to Excel: Continuously seek innovative solutions to enhance processes.
    • Perform with Accountability: Demonstrate ownership of responsibilities and deliverables.
    • Lead with Empathy: Build positive relationships and provide support to team members.
    • Act with Agility: Adapt to changing priorities and regulatory demands effectively.
  3. Other Skills:

    • Strong analytical and problem-solving abilities.
    • Excellent communication and documentation skills.
    • Proficiency in managing teams and mentoring subordinates.

Job Location

Vikhroli


Shift Hours

(To be determined based on operational requirements)


This position offers an excellent opportunity to contribute to Cipla's innovative R&D initiatives. Join us to shape the future of pharmaceutical development with your expertise and dedication!