TEPHRA
TEPHRA is hiring: Industry Advisor Pharma Manufacturing in Edison
TEPHRA, Edison, NJ, United States
Description:
Responsibilities:
• Lead discussions with the prospective customers in positioning advisory services with focus on the Pharma Mfg operations transformation & Digital Plant Solution.
• Work closely Industry Solutions unit to formulate business strategies for new growth avenues in the target account
• Provide subject matter expertise, solution strategies, domain competence development and dissemination of knowledge on new technology trends in the domain to delivery teams.
• Build ROI models and the KPI's for monitoring success of the investments proposed.
• Support Geo sales teams in sales process cycle and help new logo acquisition team in Go-to-Market Strategy.
Qualifications:
The candidate must have :
• Excellent Understanding of Pharma Manufacturing ( Chem API , Bio API, Formulations , CRO's, CRAMS)
• Understanding of Pharma Mfg challenges from operations, Quality and Regulatory perspective and ability to prescribe strategic solutions to address the challenges.
• Experience of developing ROI based Mfg operations transformation prepositions to the Leading global Pharma Mfg consultants.
• Exposure to the latest technology trends in the Digital Manufacturing and IOT based solutions.
• Excellent Knowledge on Information technology and Architecture applied to business process/rules in a pharma mfg environment.
• Conversant with the usage of Enterprise as well as Plant IT applications across ISA S95 ERP, PLM, Plant Engineering, MES, Lab informatics, DCS, SCADA, HMI, etc. in the pharma manufacturing industry.
• Familiarity with S95 & S88 standard- Language, definition and guidelines for integration of enterprise business systems and manufacturing control systems, viz level 0 - level 4.
• Familiarity with leverage of Mfg IT system like ERP-SAP, Asset Management solutions - Maximo, Plant Engineering - Intergraph (Smart Plant), MES - Werum, Pharma Suite, Lab Informatics - Labware, BioVia, Sample Manager etc. and DCS - Emerson for connected digital enterprise.
• Good familiarity with the regulatory environment viz the cGxP requirements of the US FDA . Familiarity to the GAMP, CFR Part 11, IQ, OQ, PQ and their relationship to the GMP
• Plant Engineering would be an added advantage. Being abreast with latest trends in pharma industry like, Digital Tech Transfer, Global Recipe Management, Real-time Batch Release, Predictive Quality & Maintenance for Yield improvement, Quality by Design , Lean Pharma, PAT would be an added advantage.
1) Years of experience required for position - 15+ years of industry Experience
Responsibilities:
• Lead discussions with the prospective customers in positioning advisory services with focus on the Pharma Mfg operations transformation & Digital Plant Solution.
• Work closely Industry Solutions unit to formulate business strategies for new growth avenues in the target account
• Provide subject matter expertise, solution strategies, domain competence development and dissemination of knowledge on new technology trends in the domain to delivery teams.
• Build ROI models and the KPI's for monitoring success of the investments proposed.
• Support Geo sales teams in sales process cycle and help new logo acquisition team in Go-to-Market Strategy.
Qualifications:
The candidate must have :
• Excellent Understanding of Pharma Manufacturing ( Chem API , Bio API, Formulations , CRO's, CRAMS)
• Understanding of Pharma Mfg challenges from operations, Quality and Regulatory perspective and ability to prescribe strategic solutions to address the challenges.
• Experience of developing ROI based Mfg operations transformation prepositions to the Leading global Pharma Mfg consultants.
• Exposure to the latest technology trends in the Digital Manufacturing and IOT based solutions.
• Excellent Knowledge on Information technology and Architecture applied to business process/rules in a pharma mfg environment.
• Conversant with the usage of Enterprise as well as Plant IT applications across ISA S95 ERP, PLM, Plant Engineering, MES, Lab informatics, DCS, SCADA, HMI, etc. in the pharma manufacturing industry.
• Familiarity with S95 & S88 standard- Language, definition and guidelines for integration of enterprise business systems and manufacturing control systems, viz level 0 - level 4.
• Familiarity with leverage of Mfg IT system like ERP-SAP, Asset Management solutions - Maximo, Plant Engineering - Intergraph (Smart Plant), MES - Werum, Pharma Suite, Lab Informatics - Labware, BioVia, Sample Manager etc. and DCS - Emerson for connected digital enterprise.
• Good familiarity with the regulatory environment viz the cGxP requirements of the US FDA . Familiarity to the GAMP, CFR Part 11, IQ, OQ, PQ and their relationship to the GMP
• Plant Engineering would be an added advantage. Being abreast with latest trends in pharma industry like, Digital Tech Transfer, Global Recipe Management, Real-time Batch Release, Predictive Quality & Maintenance for Yield improvement, Quality by Design , Lean Pharma, PAT would be an added advantage.
1) Years of experience required for position - 15+ years of industry Experience