Title: Manager-2

Position Title: Research Manager

Designation of the Incumbent: Research Manager

Reports to : Research Manager

Supervises : None

Position Summary:

Accountabilities:

This role is a part of Characterization Group of Analytical Research and responsible for different development and process optimization support related to characterization adhering to GXP norms in API and Drug Product.

• To provide Analytical support to CRD, PDR, DRA, AD (Internal) and plant by analyzing the API and drug products by various characterization techniques like NMR, XRD, FT-IR, DSC, TGA, DTG and CHNS/O etc.
• Method Development and routine analysis support to API and Drug product for CRD and PDR for NMR, XRD, FT-IR, DSC, TGA, DTG and CHNS/O.
• Method Validation support to API and Drug product for CRD and PDR for XRD, FT-IR, DSC, TGA, DTG and CHNS/O etc.
• Method transfer at plant locations for the above techniques.

Level of Responsibility: Medium

Scope: Job is required for Global markets

Dimension: not Applicable

Budget

• o Capex
• o Revenue
• Total manpower headcount under purview: Not Applicable

Delegation of Responsibility:

In his absence jobs will be allotted to different analyst by group lead.

Job Profile:

• Analyzing the samples of APIs and drug products using various characterization techniques like NMR, XRD, DSC/TGA/DTG, CHNS/O and FT-IR.
• Method development and routine analysis support to API and Drug product for CRD and PDR for NMR, XRD, DSC/TGA/DTG, CHNS/O and FT-IR.
• Method validation support to API and Drug product for CRD and PDR NMR, XRD, DSC/TGA/DTG, CHNS/O and FT-IR.
• Method transfer at plant locations for the above techniques.
• Analysis involved in depth technical skills, observation power, conversant with multiple technique and literature search capabilities.
• Adhere to compliance, Documentation Integrity and Performance Execution.

Technical updations, seminars, and compliance:

• Job requires continuous individual up gradation in terms of recent technical activities and attending SOP/compliance related trainings

Assessment and Planning of Work

Work generated by job holder:

• Performing planned activities like routine characterization and analytical method development, method validation and method transfer to plant location.
• To ensure compliance related activities like calibration of respective instruments, labeling of instruments, equipment’s and monitoring cleanliness of the lab.

Work generated in consultation with job holder’s superior:

• Method development activity
• Method validation activity
• Method transfer activity

Work generated by others:

• Not applicable

Problems/ Key Features

• Coordination with other departments (PDR, CRD, DRA) during day to day activity.
• Challenge to develop methods using cutting edge techniques and validate analytical methods.

Interface:

Internal: CQA, CRD, PDR, DRA and Manufacturing locations and other groups of the department.

External: Not applicable

Competencies Required:

Technical Competencies:

• Technical Competencies to handle and interpret data generated on NMR, XRD, DSC/TGA/DTG, CHNS/O, FT-IR etc.

Behavioral Competencies:

• Effective communication and interpersonal skills
• Capability to work in a team
• Willingness to learn new techniques
• Effective inter departmental coordination