Manager MS&T
TAPI
- Gajraula, Uttar Pradesh
- Permanent
- Full-time
- Performs technical evaluations of incoming RFPs and existing program extensions across capabilities including proposed scope of work, costing, timelines, and budgets with limited guidance from more senior level technical Evaluations Specialists and Management.
- Ensure project delivery as per plan and QA norms
- Provide technical guidance and lead project reviews.
- Ensure and regularly review compliance with all statutory, legal, environmental, licensing, regulatory, and safety norms and fulfill commitments to regulatory agencies, customers, and quality management
- Complete technical evaluation into appropriate cost model and proposal templates for proposal generation.
- The successful candidate will have a background in Chemical Engineering with experience in a relevant pharmaceutical or CDMO industry
- Assesses with Operations and Management and recommends capabilities to meet Client requirements as part of technical evaluations.
- Represents technical operations in front of Client in support of project acquisition with Sales & Business Development, Project Management, and/or Partnership Management.
- Attends Client site visits, presentations for new, and extension of existing opportunities.
- Ensuring that equipment works to its specification and to appropriate capacities of products
- Contribute novel ideas by way of participation during technical discussion with superiors/ Colleagues
- Preparation of Capex Proposals (Concept notes, Savings/Payback calculations) for purchase of new Process Intensification technologies, co-ordination with cross functional teams for purchase, installation and commissioning related activities
- Knowledge to use process modelling tools like Dyno Chem ,VISMIX for reaction, crystallization, filtration, solubility and mixing studies
- Study the process and recycling of solvents, performing experiments in PD Lab, generating data, proposing changes/modifications in recovery processes and establishing recovery process for new solvent streams for target improvement in the solvent recovery.
- Person will have demonstrated expertise in the scale-up and process understanding of chemical process unit operations in the manufacture of APIs, intermediates and raw materials. Experience in Quality by Design, process safety, technology transfer and commercial production would be advantageous.
- In-depth, hands-on expertise and up-to-date knowledge of a wide range of chemistry unit operations such as reactions, distillation, separation, filtration and drying.
- Strong scientific record of accomplishment, ability to handle several projects in different stages of development at the same time.
- Person will be responsible to Investigate and troubleshoot in case of issues in scale up/validation and support troubleshooting activities in case of issues in scale up/validation batches
- Excellent communication skills to interact internally with project teams and externally with customers
- Good understanding on CDMO business, RFP preparations in stretched timelines
- Good project management and supervisory skills.
- Collaboration and influencing skills to build partnerships with the other disciplines, similar groups, Conscientious with a can-do attitude and thorough attention to detail.
- Experience in working to GMP & FDA adherence
- Qualification: B. Tech/ M. Tech Chemical
- Experience: 12 to 15 Years
- Key Skills: Good understanding of CDMO Business, Equipment mapping, RFP preparation, CFT alignment & Collaboration, Process Engineering calculations, Technology Transfer, knowledge of FDA regulations/ ICH guideline, OH cost calculations.