Manager Manufacturing Science and Technology (MSAT) - Process Support

Job Description

ROLE SUMMARYThe role of Manager MSAT Process Support will be to Lead technical support to Manufacturing Team in Trouble shooting, Continuous Process Verification and Process improvement, use of 6 sigma methodologies to trouble shoot technical issues.ROLE RESPONSIBILITIESKey AreasActivitiesTechnology Transfer / Regulatory filing support Perform developmental activities for new molecules/ Products, NDAs, ANDAs, Literature survey, RLD characterization, Pre-formulation Studies, Prototype Formulations and Filter validation studies, Scaleup and Exhibit batches. Prepare Technical data, Gap assessment, Risk assessment reports, Identifying and evaluating CPPs, Stability data, Annual Product Quality Reports, Technical documents from originating site. Design and execute Remediation activities like feasibility batches, Stability studies (R&D), Scaleup and Exhibit batches as per timelines for Existing molecules/ Products. Plan for Technology Transfer process including various activities like procurement of API, excipients, equipment s for the developmental, Optimization, Scale up and Exhibit batches. Coordinate with external customers like Filter validation service providers & Vendors etc. Plan and execute for Technology Transfer process including various activities like procurement of API, excipients, equipment s for the developmental, Optimization, Scale up and Exhibit batches. Review necessary guidelines/ SOPs for Developmental/ Technology Transfer activities. Technical support to Manufacturing Team for smooth launching of products. Prepare Scale up Protocols and Reports, Technology Transfer Protocols and Reports, Product Development Reports etc. Coordinate with external customers like Filter validation service providers & Vendors etc. Finalization of manufacturing Process and Parameters/ CPPs for Scale up and Exhibit batches manufacturing. Support to Regulatory Affairs for NDA/ ANDA filing activity, respond to Regulatory queries and audit support. Review of developmental work and guiding the Research Executives in Project work. Ensure the compliance to cGMP/ cGLP, organizations procedures and practices Ensure all the safety precautions are followed while at work.Commercial / Process validation support Review and Approve Process Validation and Commercial Batch records. Trouble shooting, ongoing technical support to Manufacturing team for Process validation, Continuous Process Verification and Process improvement. Ensure the compliance to cGMP/ cGLP, organizations procedures and practicesManufacturing Investigation Support Actively involve in Investigations related to Process and Equipment to evolve CAPAs and monitor the effectiveness of CAPAs. Be able to apply DMAIC tool to drive investigation studies. Use of 6 sigma methodologies to address the investigations and drive CAPAs implementation. Black belt certification preferred. Performing day to day activities with Data Integrity Principles and Procedures.Cultural AttributesThe incumbent is expected to conduct in line with the Pfizer Values; Courage, Equity, Excellence & JoyStatutory ObligationsIncumbent is expected to conduct in line with relevant legislation pertaining to workplace health and safety, discrimination, harassment and bullying.Environmental Health and SafetyParticipate in and take responsibility for workplace environment, health and safety at the level required for this position, following the guidelines in the company Environmental, Health and Safety Management System Manual.ESSENTIAL REQUIREMENTSPreferred Education/ QualificationPh.D./M. Pharm/ MSc/ M.Tech with specialization in Pharmaceutics/Pharmacy or any discipline of Science and Technology)Experience12 to 18 years of experience in Formulation Development/Process Development/ Product Development/ Production/ Technology Transfer of injectable formulations to cater regulated markets, essentially experience in Plant Technology Transfer support in Injections.Core Competencies Knowledge in parenteral formulation development like liquid/ dry powder and lyophilized formulations Experience in execution of Scale up/ pre-exhibit and exhibit batches Exposure in preparation and review of technical documents like TTP protocol/ Scale up protocol and BMR etc. Experience in active participation and closure of InvestigationsStandards, Processes & Policies Awareness on company policies Awareness of safety at working place Quality policies, procedures Current GMPDESIRABLE REQUIREMENTSAdvanced Competencies Problem Solving: Ability to investigate, identify root cause and preventative measure using DMAIC tool and other appropriate tools. Technical Writing: Ability to create documentation that is accurate, complete, unambiguous and as concise as possible aimed at different levels of the organization. Excellent attention to details Strong interpersonal skills and communication skills. Coaching and Mentoring skills.Additional Desirable RequirementsPurchase, Analytical R&D, Production, Quality Control, Regulatory Affairs, Quality Assurance, Project Management, Warehouse. SAP MES, Validation & Engineering etc., for seamless Technology Transfer.Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Engineering #LI-PFE,

Keyskills :
continuous improvement facilitationmusic makingstrong interpersonal skillssafety management systemroot causeequal employment opportunityblack belt