This position is responsible for overseeing the development of robust and efficient processes for extracting and purifying recombinant proteins expressed in plant tissue or other expression media and scaling them up for production. This position Manages and plans for process development needs for projects and Outlines process development methodology for projects.

Responsibilities include:

• Suggest and develop methods for the production, purification, fermentation, and testing of new process formulas, technologies and products
• Improve manufacturing techniques and new process equipment production
• Develop, optimizes and implements process steps for protein purification and implements methods for analysis of purification fractions
• Manage personnel and the activities in downstream process development, including training, materials control, investigations, and supplier qualification
• Prepare publications and oral presentations, as requested
• Write technical and scientific reports, protocols, study reports and related documentation

The qualified candidate will have:

• MS or Ph.D. in Biochemistry, Chemistry, Engineering or other related discipline
• 8+ years experience in Research and development experience that enables product development and/or scale up of processes from bench to commercial scale production
• Demonstrated knowledge of vaccine development, cell culture methods, downstream purification processes, and analytical tools
• Experience in small and large scale manufacturing
• Competence in plant and cell-based protein production, including post-translational modifications
• Experience in leading technical teams in research and development and/or engineering
• Effective written and oral communication skills

Industry: Biotherapeutics, vaccine, cell culture, GMP, scale up, Scientist, R&D, Process Development, protein, post-translational, downstream purification, analytical  

Job Code: 352-32-MH2322

Location: Texas

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The Wellington Group ( http://www.twgrecruiters.com) 910-338-2795

This position is responsible for all process development programs within the company. This position will lead both upstream and downstream process science teams to support overall early to late stage clinical/commercial process development within a biotherapeutics manufacturing environment. The Senior Director will oversee all major technology transfer processes for vaccine and other therapeutic manufacturing to and from the company.

Responsibilities include:

• Oversee the management of personnel and the activities in upstream and downstream process development, including training, materials control, investigations, and supplier qualification
• Provide leadership in developing upstream processes used in the biological therapeutic protein and vaccine manufacturing at both bench and large scale commercial applications
• Oversee processes related to downstream purification techniques used in current good manufacturing practice (cGMP) therapeutic protein and vaccine manufacturing at both bench and large scale commercial applications
• Lead the development of gene expression, cell culture, and purification technologies and processes from late research through commercial product launch
• Establish processes, set points and overall process optimization by working with all critical parameters within a variety of manufacturing platforms
• Ensures proper separation technology in centrifugation, depth filtration, microfiltration and tangential flow and ultra-filtration for purification applications
• Ensure successful interaction with national and international regulatory agencies, such as the FDA and EMEA, as well as internal and external audits
• Acts as a liaison between the company and external clients or partnerships

The qualified candidate will have:

• MS or Ph.D. in Biochemistry, Biology, Chemistry, Engineering or other related discipline
• 15+ years experience in Biologic and/or vaccine development experience with demonstrated expertise in cell based production of viral vaccines, protein purification, and antibody purification
• Demonstrated knowledge of vaccine development, including upstream processes, expression systems, viral replication processes, viral inactivation, cell culture methods, downstream purification processes, analytical tools and techniques, manufacturing organization, and Quality Control
• Experience in the overall early to late stage clinical/commercial process development within a biotherapeutics manufacturing environment
• Competence in methodology for the design of experiments (DOE) and associated statistical support software programs is required
• Must have a successful track record of filing BLAs and INDs to support commercial product approvals and clinical product development
• Skill in appropriate scale up techniques from the bench to the manufacturing floor with appropriate upstream technologies
• Ability to lead and manage complex professional and technical teams
• Effective written and oral communication skills 

Industry: Biotherapeutics, vaccine, upstream, downstream, cell culture, BLA, IND, scale up, DOE, Process Development, Scientist, Engineering, Pilot Plant

Job Code: 351-32-MH2322

Location: Texas

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Don’t wait, apply with The Wellington Group today!
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The Wellington Group ( http://www.twgrecruiters.com) 910-338-2795

 Don’t wait, apply with The Wellington Group today!
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 The Engineering Manager will be responsible for all design, bills of materials, shop support and final product reviews before release to manufacturing. Ideal candidate has a strong background in both mechanical and electrical engineering for new metal or steel products, experience leading a team of people and engaging with both foreign and domestic clients for custom or highly fabricated work.

 Primary responsibilities include:

• Manage and coordinate R&D projects from the design center to the shop floor and out to manufacturing
• Manage and drive initial meetings with sales, manufacturing, engineering and quality to review design and development needs
• Supervise a large, diverse staff to include designers, engineers, procurement and technicians
• Interface with sales, marketing and client base to ensure design and functionality fits the customers need
• Work with direct staff and manufacturing teams to resolve issues
• High priority is to ensure final product meets the scheduled ship date the client
• Responsible for all product design, BOM, engineering and design support and coordination with manufacturing

 The qualified candidate will have:

• BS in Engineering, experience in both mechanical and electrical engineering is ideal
• Sheet metal and structural steel knowledge
• Experience in all aspects of product development, must be proficient in the latest version of AutoCAD
• Ability to interface with sales engineers, designers and customers
• Proven management experience, able to hire, teach, train and mentor others
• Relevant product and industry knowledge with industrial machinery

Industry: Engineering, AutoCAD, metal, steel, design, industrial, heat treat, electrical, BOM

Job Code: 349-32-MH2322

Location: North Carolina

Apply directly to: http://www.maxhire.net/cp/?E55F6E361D43515B7D52182B77571A63482D7D

Permanent position with a locally managed company offering great benefits and salary.

The Wellington Group ( http://www.twgrecruiters.com ) +1 910-338-2795

Don’t wait, apply with The Wellington Group today!
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Responsibilities include:

• Involved in new product scale-up, process optimization, technology transfer and process validation activities
• Develops and implements manufacturing processes for clinical and non-clinical product
• Develops a deep understanding of the manufacturing process and how it affects the product performance
• Designs, builds, acquires and maintains methods and tools for process improvements
• Assists the manufacturing operation in problem solving with regards to equipment and systems
• Establishes operating equipment specifications and improves manufacturing techniques
• Develops and recommends new processes and technologies to achieve cost effectiveness and improved product quality
• Interfaces with various departments to ensure processes and designs are compatible for new product technology transfer and to establish future process and equipment automation technology
• Creates and edits manufacturing machine related documentation, including Standard Operating Procedure (SOPs) and instrument troubleshooting guides
• Creates, edits and executes protocols and writes protocol reports
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors
• Implement process controls to achieve production and quality targets
• Perform IQ/OQ/PQ qualifications for equipment and processes
• Perform weekly inspections of hazardous waste containers
• May transport hazardous waste from satellite accumulation area to chemical waste storage room

The qualified candidate will have:

• Demonstrated experience with CPK, tech transfer, data analysis and process / manufacturing troubleshooting
• 5+ years medical device or pharmaceutical manufacturing, experience in drug combination therapy processes is ideal
• BS /MS Mechanical Engineering, Chemical Engineering, or related discipline
• Excellent communication skills and problem solving skills
• Solid knowledge of current Good Manufacturing Practices (cGMP) applicable to the FDA and comparable international regulatory agencies
• Ability to plan and schedule multiple projects and tasks
• Good knowledge of MS Office Suite and MS project and basic knowledge of Solid Works

Industry: Pharmaceutical, Biotechnology, Medical Device, Process, Engineering, GMP, Validation, Scale-up, Tech Transfer, Solid Works, R&D

Job Code: 322-32-MH2322

Location: North Carolina

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The Wellington Group ( http://www.twgrecruiters.com) 910-338-2795

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Industry: Pharmaceuticals, Biologics, Medical Device, FDA, Regulatory Affairs, Submissions, 510k, NDA, CE, IND, CMC, Marketing and Advertising, Promotional

 Job Code: 348-32-MH2322

 Apply directly at: http://www.maxhire.net/cp/?E55B6B361D43515B7D52182B77571A6D482E

 Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance.

The Wellington Group ( http://www.twgrecruiters.com) 910-338-2795

Don’t wait, apply with The Wellington Group today!
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Position Duties and Responsibilities:

• Evaluate, establish and manage a network of suppliers the global organization can access
• Manage KPIs and financial metrics against goals and supplier proposals and forecasts
• Develop and manage budgets for the procurement of goods needed from key sources
• Analyze data from RFPs to select the most appropriate global suppliers and partners
• Report to Sr Management on the status of the procurement process, supply chain, COGs and inventory as well as changes to market conditions, suppliers and global corporate needs
• Work with internal and external departments and partners to ensure global compliance and safety / regulatory standards are being met by suppliers and partners
• Assist the R&D and innovation teams in science and engineering with new product and supply chain for changes and capital equipment and commodities or non-commodities
• Presentation of data and key metrics or supplier and market responses to Sr Management and suggest appropriate selections based on needs and the company brand integrity
• Hold suppliers, vendors and partners responsible to quality, price, delivery and other key metrics
• Manage the purchase order process and review or audit to ensure compliance to SOPs and contracted or correct pricing
• Review the purchasing process to recommend changes to SOPs and internal process for the review of needs, access and selection of vendors and enhancements to include new technology
• Oversee the hiring, training and management of purchasing department staff to include buyers, coordinators, analysts and others tied to the department

The qualified candidate will have:

• Minimum of BS Degree is required, MBA or Graduate Degree is preferred
• Minimum of 3-5 years in global (domestic and international) procurement
• Excellent analytical and problem solving skills
• Proven record of negating skills, training and certification in purchasing is a must with CPM the ideal certification
• Experience within the food industry is a plus
• Profit Analysis on each situation is mandatory
• Must be able to work in a strong team environment and take both direction and feedback from other team / staff members for the benefit of the company and brand
• Strong communicator with international experience
• Able to travel internationally and work extended hours as needed 

Industry: Food, Beverage, grains, procurement, purchasing, international, global, non-commodity, CPM, KPIs, supply chain

Job Code: 347-32-MH2322

Location: North Carolina

Apply directly at: http://www.maxhire.net/cp/?E55B6B361D43515B7D52182B77571A6D482E

The Wellington Group ( http://www.twgrecruiters.com)   910-338-2795

The Regulatory Affairs Professional will be responsible to assist in the design and configuration of medical devices to assure compliance to FDA specifications. The candidate will be expected to provide guidance on 21 CFR Part 11 compliance in the implementation of software inherent in the medical devices.

Responsibilities include:

• Assist in the design and implementation of test parameters for medical devices
• Provide guidance as to the data required to prove integrity of the medical software, functionality, and standardization of the medical device
• Assist in design and management of clinical trials data
• Compile clinical data package that will convince the FDA of safety and efficacy of the medical devices
• Act as a liaison with FDA to assure proper and complete regulatory filings for medical devices

The qualified candidate will have:

• BS, MS, or Ph.D. in physiology, biomedical engineering, computational biology, or medical information technology
• 10+ years experience in medical device research and development
• Demonstrated knowledge of medical device IT processes, specifically, understanding of 21 CFR Part 11 FDA regulations
• Experience in trauma related automated medical devices is a definite plus (e.g., AEDs, vital sign monitors, pulse oximeters, respirators) is a plus
• Must have a successful track record of filing 510(k) and IDEs with FDA and writing documents for FDA filings and reports
• Effective written and oral communication skills

Industry: IT, 21 CFR Part 11, Medical Device, 510(k), IDE, design, engineering, R&D, AED, FDA
Job Code: 346-41-MH2322
Location: Texas

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The Wellington Group ( http://www.twgrecruiters.com ) 910-338-2795

The Engineer will be responsible for product design and development of RF ablation catheters for renal nerve ablation systems. Responsibilities include completion of bench testing and pre-clinical animal studies to define key design and ablation algorithm parameters and translation of performance requirements into product specifications.

Responsibilities include:

• Successfully complete complex engineering work in: technology development, product design and development, preparation of product specifications, research investigation (animal and clinical studies), and report preparation
• Summarize, analyze, and draw conclusions from complex test results using valid statistical techniques
• Design and prepare reports to effectively communicate results clearly and completely to technical community
• Interface with Physicians and/or Catheterization Lab personnel to obtain feedback on concepts and performance of new devices
• Consistently generate innovative and unique solutions to market needs and submit invention disclosures
• Drive design verification and validation activities for catheter and system specifications
• Build Quality into all aspects of work by maintaining compliance

The qualified candidate will have:

• 4+ years experience in design and development of medical devices, hands on experience with RF ablation catheter is required
• BS, MS or PhD in Mechanical, Chemical, Biomedical or a related Engineering field
• Strong communication, collaboration and critical-thinking skills
• Solid understanding of risk management
• Experience with qualifying medical devices to electrical standards
• Competent in the application of Design of Experiments methodology (Design-Expert) & statistical analysis software (Minitab preferred)
• Experience with design controls, FDA regulation, GMP practices, and QSR requirements
• Prepare design /engineering documentation aspects in support of FDA submissions

Industry: RF, Medical Device, catheter, ablation, design, engineering, R&D

Job Code: 345-32-MH2322

Location: North Carolina

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The Wellington Group ( http://www.twgrecruiters.com) 910-338-2795

The Senior Engineering Consultant will be responsible for assisting the company with the transition of the Industrial Furnace Product line transition from Electrical to Gas Fired. All products are industrial based furnaces or ovens which are custom designed and built to the needs of each client.  You will work with executive management, designers, drafters, production managers and production personnel on developing the specifications, operating procedures, training and product lines to make this transition happen over a 1 to 3 year period.

The qualified candidate will have:

• Degree in engineering
• Proficient in AutoCAD and Solidworks
• Proven experience in reading and checking blue prints
• Ability to lead and train others
• 10+ years in Gas Furnace and Industrial Ovens, heat-treat
• Strong verbal and written communication skills
• Ability to interface with executive management, sales, engineers, designers and customers
• Capable of working in Israel on a 1 to 3 year commitment (as an expat with full travel, Visa, living and working costs covered)

Industry: Engineering, Heat-Treat, Industrial Furnace, Industrial Ovens, Gas, Design, Israel

Job Code: 344-MH2322

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Permanent position with a locally managed company offering great benefits and salary.

Don’t wait, apply with The Wellington Group today!
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The Wellington Group ( http://www.twgrecruiters.com ) +1 910-338-2795

The OTC Product Manager is responsible for development of business plans and product positioning in the marketplace, as well as oversees market research and all competitive activity/analysis. You will work with a new company division, supporting both current and new customers and new product offerings. May also support existing product needs in the area of medical devices, medical equipment and disposables.

 Responsibilities include:

• Evaluate new products by researching and analyzing the existing, forecasting sales of products within existing and potential markets and assessing the ability of products to meet current and potential needs
• Lead the marketing development effort to bring new products from concept through commercialization including market exit
• Prepare and write brochures and sales materials
• Develop and execute competitive strategies based on thorough competitive intelligence and market analysis
• Provide with market intelligence and market research, feedback from the field on product launches, acceptance, and market conditions
• Provide on-going product and sales support
• Manage and mine existing client relationships for an opportunities to increase revenue and market share
• Responsibility for reviewing and issuing proposals to clients as well as negotiating all commercial aspects of contracts with prospective clients

The qualified candidate will have:

• Bachelor’s degree in marketing, business, or health science, MBA preferred
• 3 to 5+ years experience with medical device and/or pharmaceutical distributors, pharmacies, pharmacy-cooperatives
• Prior experience working with mass merchandisers in product management, product marketing, or in a product based business development role
• Demonstrated knowledge of FDA regulations and product marketing guidelines
• Strong attention to detail with ability communicate effectively
• Experience working with international suppliers, English and Spanish communication skills are highly desirable
• Ability to work successfully with globally dispersed teams across multiple time zones
• Ability to prepare professional written and deliver oral presentations and market analysis
• Excellent at multi-tasking, managing large projects and managing resources

Industry: Product Marketing, Product Management, OTC, Medical Device, distributors, market analysis, forecasting, negotiations

Job Code: 343-32-MH2322

Location: North Carolina

Apply directly to: http://www.maxhire.net/cp/?E55E6A361D43515B7D52182B77571A69482D7D    

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

The Wellington Group ( http://www.twgrecruiters.com) 910-338-2795