Scientist - Ds/api Manufacturing Operation Support

**Need: DS/API Scientist/QC/LCM- Remote job**

**Title**:DS (Drug Substance) Technical Operations Associate***

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**DS (Drug Substance) Technical Operations Associate** will provide End-to-End support for Drug substance, starting materials and intermediates manufacturing processes of commercial products at the External manufacturing sites in ASPAC. You will be working with cross functional teams owning the responsibility for the reliability of product processes for the company’s Supply Chain. This individual will support the following:

- Technically support Life cycle management (LCM) and New Product Introduction (NPI) of products produced at EM’s as CMO
- Enhance reliability, compliance & efficiency of product value chains end to end.
- Provide technical support and have oversight basis need for EM’s with pure buy model.
- Providing technical support for External pharmaceutical manufacturing network to ensure operational excellence, product quality, and optimal product flow to respective markets.
- Works with the regional/global commercial sites to facilitate new and in-line technology transfer and commercialization projects.
- Scale up, Technology transfer, process characterization, Validation Master Plan(s), including but not limited to process validation and cleaning validation as applicable.
- Process and cost improvements
- Standards and new technology deployment
- Following all applicable Global SOPs and Guidelines

The **Technical Associate **is expected to demonstrate CREDO-behavior and to continuously focus on safety, quality, GMP and operational discipline

**PRINCIPAL RESPONSIBILITIES**:

- Co-ordinates the technical activities of the DS processing by colloborating with site, quality & compliance, process science, product specifications, analytics, stability, regulatory and ensures good oversight of the technical aspects of the API, intermediates or starting material synthesis steps.
- Supports with inputs for building business cases and participates in project prioritization

exercises.
- Executes or follows-up on execution of all technical actvities/ initiatives /projects. Validation of Manufacturing Processes and Monitoring (Product process, Cleaning)
- Collaborates with DPDS, site functions and other functions for improvement opportunities
- Participates in technical risk management assessments and related BCP requirements
- Provides input from the API Technical Team to relevant stakeholders, groups.
- Acts as the API synthesis Point of Contact with manufacturing sites
- Supports trouble shooting / investigations /Complaints / Recovery process if any etc. for API related technical issues
- Represents the DS manufacturing sites at any escalation meetings.
- Supports the review and approval of changes related to the API
- Ensures criticality analyses are kept up to date.
- Provide process / technology input to SOP’s, Master Batch Records, and change controls
- Partner with Engineering & Maintenance and contribute to equipment changes / introduction projects on the site
- Perform process development as part of process improvement (scale up, equipment transfer, performance improvement, etc...)
- Supports relevant audits and inspections.
- Provide Technical Assessments to Change Controls/CAPA’s and Deviations
- Maintain excellent partnership with all business partners
- **Technology & product technical life cycle management**:

- Plan, manage / execute the technology transfers, process characterizations, validation program related to LCM / NPI such as process validation, cleaning validation etc.
- Prepare / Review validation plan, protocols, and reports
- Execute or oversee the validation/characterization/demo runs in the field and / or oversee the execution done by validation technicians of EM sites
- Overall coordination of LCM projects on site
- Issue / review tech transfer strategy, validation plans, protocols, and reports
- Participate in the CPV (continued process verification) program by issuing plans, protocols and reports and oversee the execution.

**KEY COMPETENCIES**

**1. **Technical**:

- Demonstrates competency and experience with API manufacturing and thorough technical knowledge of manufacturing unit operations.
- Drives for innovation and change to ensure competitiveness.
- Engineers new, and modifies existing, processes to increase efficiencies.
- Strong expertise in Small Molecule API business
- Hands on experience in statistical tools like Excel, Minitab, etc.....

**2. Decision Making & Problem Solving**:

- Strong mindset and knowledge of Quality & Compliance / regulatory requirements (GMP/EH&S).
- Able to solve complex or unusual problems independently or through others and develop recommendations or design solutions.
- Understanding of costing systems to support COGs sensitivity assessments as well as financial tools.

**3. Communication**:

- Demonstrates strong communication skills across all levels.
- Influences others with shared interests often beyond s