Pride Circle Banner Image Pride Circle Banner Image
Image

Senior Scientist-Process Scale up transfer

 Hyderabad  8  1974

11 Views Today

Share 

Job Details

Company Top Pharmaceutical Giant
Position Senior Scientist-Process Scale up transfer
Required Experience 8-10 Years
CTC Best in the Industry
Location Hyderabad
Job Code 1974
Posted On 07 Sep 2021
Application Deadline 28 Feb 2022

Skills


Product Development, Project Management, Process re-engineering, HSE, Six Sigma,

Description


Job Description

We have more than 130 years of experience treating patients.It is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.

Position Purpose

Responsible for development, scale up and tech transfer to internal and external manufacturing sites (CMOs). Provide process-engineering expertise and will use problem-solving techniques to resolve process difficulties, reduce waste, improve productivity and safety.

CMO/CRO/STO finalization based on molecule nature and process understanding. Senior scientist will also provide technical support to site operations, maintenance and manufacturing personnel for supported processes.

Additional job duties include investigating new technologies and their applications to manufacturing processes and assisting in development of products and processes for contract manufacturing projects.

Shall own and design the strategy to troubleshoot the issues arising during scale up operations. Assists in the preparation of and reviews the reports and protocol that form part of technology transfer dossier for example, but not limited to, MFR/BMR, HTSP/R, QRM, MFCs, stability protocols etc.


YOUR KEY RESPONSIBILITIES:

Your responsibilities include, but are not limited to:

• Provides Process-engineering expertise to technology transfer of projects to internal and external manufacturing locations. Provide technical expertise to the project execution team. Perform process engineering analysis to determine cycle time, equipment fit, technologies required, scale up risk etc.

• Perform engineering analysis of process execution, recommend opportunities for improvement, process modeling, process flow diagrams, compatibility assessments, risk management etc.

• Support process validation and commercialization activities for process transfers to external suppliers.

• Develop, write and review protocols and reports for the following batches: Product characterization, Tech transfer, Exhibit/Registration and Validation.

• Develop innovative ideas and alternatives leading to lean, efficient and cost effective processes. Participate in Hazard and Operability (HAZOP) studies.

• Design, plan and perform/supervise scientific experiments and contribute to project related scientific/technical activities under minimal supervision (e.g., interpret and report results, generate and evaluate data, draw relevant conclusions, optimize existing methods/processes).

• Material knowledge - data-driven procedure to facilitate materials selection and help accelerate pharmaceutical development studies. Should have understanding of Physical, chemical and surface morphology of the material in-depth, Facilitates the risk assessment of any material in such a way that the drug product development and secondary process selection can be accelerated.

• Digital Initiatives - Digital Transformation is the process of upgrading or establishing a new way of carrying out critical process activities, as well as building new or adapting current trends, culture, and experiences, using digital technology to meet changing business and market requirements. Establish innovative solutions for verification and control of critical product attributes or critical process parameter in cooperation with other colleagues. Work to enable process to be simpler, better and faster using best practice frameworks and tools not limited to lean six sigma, agile, simulation and modeling etc.

o PAT tools – understanding the use and application of PAT tools to automate the process.

• If assigned this task, maintenance of infrastructure/equipment and required investments (e.g. system ownership).

• Report and present scientific/technical results internally (technical governance meets, knowledge sharing sessions etc.) and contribute to publications, presentations, and patents.

• Keep track of logistical arrangements for upcoming and ongoing technology transfers at manufacturing sites that includes, but not limited to maintaining records pertaining to the timelines for execution of different Technology transfer batches, availability log for raw materials and relevant documentation.

• Process parameters calculation based on scale up factors for proposed batch size based on available data. Batch size calculation at pilot BE, registration stage based on equipment capacity, API ordered, market forecasted etc.

• Actively participate in knowledge exchange. Train and coach associate scientists and technicians, temporary employees, and employees under training/education.

• Adherence to standards, in particular quality (cGxP, data control), ethical, health, safety, environment (HSE), and information security (ISEC).

• Support during internal and external audits and inspections.

• Support during investigation of deviation, OOS/OOE, CAPA’s, FMEA’s, change controls and market compliant etc. Deficiency response related to process.

• Product selection support: Liaise with the capacity management, HSE and operations teams to provide input relating to site selection, equipment selection and process selection during product selection.     


WHAT YOU’LL BRING TO THE ROLE:

• Masters in chemical engineering/ pharmacy with at least 8 years of work related experience, or PhD with at least 4 years relevant experience

• Experience in Product development / scale up/ technology transfer activities.

• Ability to work on multiple projects concurrently and flexible to switch between projects if necessary.

• Strong scientific skills allowing the drawing of accurate assumptions from limited data to assess the next step in scale up batches.

• An understanding of experiment and validation design and the requirements when documenting protocols for these exercises.

• Should have understanding of the material science to facilitate faster and robust development.

• An understanding of the parameters involved in scaling up of formulation processes.

• Good understanding of digital initiatives and PAT tools in pharmaceuticals.

• Effective analytical and problem solving skills.

• Technical/scientific protocol and report writing skills. Practical Knowledge of statistical approaches in product formulation optimization shall be appreciated.

• Strong communication and presentation skills. Effective collaboration and interpersonal skills. Proven ability to manage and prioritize multiple activities.

• Willingness to travel to CMOs/Plants based on business needs.

Quick links