Reagent Formulation and Manufacturing Transfer Expert

Reagent Formulation and Manufacturing Transfer Expert
Norwood, MA
12+ months contract to start with (extendable and potential to convert fulltime)
 
Specific Requirements 
 The focus of this position is on reagent formulation and manufacturing integration, with emphasis on the development of packaged calibrators, quality controls and specialty reagents. In this position, the individual will work closely with R&D scientists in developing stable formulations, manufacturing processes, packaging solutions and analytical methods associated with reagents used for diagnostic assays. In addition to reagent formulation and packaging, the individual will be responsible for generating product specifications and characterizing the product. The individual will provide concurrent engineering and process development for a smooth transfer of new products/processes into manufacturing. 
 
 Desired Skills: 
 • Broad chemistry/biochemistry knowledge of aqueous chemistry. Experience with proteins, enzymes, buffer systems, surfactants and preservatives 
 • Strong experience in developing processes and reagent formulations associated with diagnostic instrumentation 
 • Packaging/laminate experience 
 • Experience in utilizing various project management tools, design tools and statistical analysis tools to ensure the delivery of robust, reliable and accurate processes to routine manufacturing 
 • Knowledge of DFSS (Design for Six Sigma) and lean methodology. 
 • Ability to initiate and execute continuous improvement projects that have bottom line impact on delivery, cost and quality 
 • Strong collaborative and team work attributes 
 • Must excel at troubleshooting, developing corrective solutions and completing projects on schedule 
 • Must be able to design effective experiments (DOE) followed by thorough data analysis 
 • Must be hands-on, willing to get into the lab to execute to plan 
 • Excellent documentation skills 
 
 Responsibilities: 
 • Assume lead role in development projects, from conception to completion (transfer to manufacturing) 
 • Deliver well-characterized and robust aqueous reagent processes to manufacturing 
 • Source and qualify external vendors 
 • Perform extensive lab work designing and executing experiments, and analyzing resultant data 
 • Document newly developed processes for DHF and IP 
 • Optimize process using Lean Manufacturing tools 
 • Perform detailed analysis by gathering data related to proper utilization of company labor, equipment, materials and facilities 
 • Provide assistance in routine planning of processes, workflow, and accident prevention measures to maintain optimum and safe utilization of plant resources 
 • Develop and maintain systems and processes to ensure packaging processes are streamlined, accurate, and on-time 
 
 Position Requirements: 
 • B.S. in Chemical Engineering, Chemistry or related scientific discipline strongly desired. Advanced degree preferred. 
 • A minimum of 10 years of relevant industry experience in Life Sciences, Medical Devices, or Diagnostics 
 • Effective verbal and written communication skills, team work and ability to take initiative 
 • Appreciation of process quality and specifications as a requirement for manufacturing. 
 
 General Requirements 
 Job Family Responsibilities: 
 
 Develops and guides the testing or investigations pertaining to the development of very complex new designs, methods, materials, or processes and investigates possible application of results. Analyzes, evaluates, and plans very complex methods of approach, and organizes means to achieve the solution to problems. Interprets and evaluates test data and results of very complex investigation and develops appropriate recommendations. Develops reports, charts, graphs, and other documents and makes recommendations to senior staff. Develops the design of a variety of very complex products, processes, and components. Reviews and approves related inputs such as very complex drawings and specifications prepared by technical support personnel. Coordinates with engineering support to arrange for the production of very complex experimental runs or for the construction of experimental models and special test equipment. 
 The positions will be responsible for working with R&D and Manufacturing management, for the coordination of cost, product and process improvements. 
 
 Key Responsibilities: 
 Performs advanced areas of work for the professional field. Applies advanced skills to resolve complex problems not covered by existing procedures or practices independently. Displays a high level of critical thinking in bringing successful resolution to high-impact, complex, and/or cross-functional problems. 
 
 Knowledge and Experience: 
 Demonstrates and applies comprehensive knowledge of field of specialization to the successful completion of complex assignments. Demonstrates advanced knowledge of concepts, practices, and procedures of particular area of specialization. Demonstrates significant knowledge of organization's business practices and issues faced and contributes to problem resolution of those issues. Typically 8-10 years of successful experience in related field and successful demonstration of Key Responsibilities and Knowledge as presented above. Advanced degree MAY be substituted for experience, where applicable. 
 
 Direction of Others: 
 Provide specialized guidance or train support and/or professional staff. Leadership qualities and role model qualities demonstrated. 
 
 Key Working Relationships: 
 Primarily intra-organizational contacts and external contacts. 
 
Thanks and Regards,
Imran (Emu) Shikalgar
APN Software Services, Inc
39899 Balentine Drive, Suite 385, Newark, CA 94560
Direct: 510-402-4704
Phone: 510-623-5050 Extn.129 | Fax 510-623-5055 | Imran@apninc.com
linkedin.com/in/imranshikalgar

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