Manager-2

**Position Title**: Research Manager

**Designation of the Incumbent**:Research Manager

Educational Qualifications

Ph.D. in Chemistry

Experience

**2.3 year in Polymorph screening and characterization**

**New Incumbent**

**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