The Manufacturing Director will work as a consultant helping Sr Management on the identification and utilization of Contract Manufacturers (CMO) on the scale-up of current products to large scale manufacturing for commercial use.

Responsibilities include:

• Work with internal and external departments, vendors and consultants on the final assembly and packaging of commercial product under GMP
• Oversight of tech transfer to include troubleshooting of all design, manufacturing and packaging issues
• Work with established QA department to design a vendor selection and auditing program
• Establish the packaging and logistics program for all vendors and suppliers
• Work with the local pilot plant, int’l suppliers and CMO on transfer to large-scale manufacturing

The qualified candidate will have:

• BS or MS in Science or Engineering, PhD is a plus
• Experience with sterile based manufacturing is requires (aseptic and clean rooms)
• Proven, hands on skills with medical device manufacturing
• Contract manufacturing site start-up experience
• Strong tech transfer knowledge and experience
• Ability to comply with all FDA and int’l regulatory standards
• Strong written and verbal communication skills
• Ability to travel as required

Industry: CMO, Medical Device, Contract Manufacturing, tech transfer, sterile, stent, implants, drug, pharmaceutical, pilot plant, engineering, R&D, science, clean room

Job Code: 337-32-MH2322

Recruiter: Lisa

Location: North Carolina

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Responsibilities include:

• Responsible for analysis and validation of all raw materials, in-process materials, final product and stability studies
• Development and validation (method development and validation) of analytical methods and assays to support the drug development, product development, product characterization, product pipeline and commercialization of all products produced
• Develop and write SOPs
• Provide technical support and subject matter expertise, both internal and external
• Work with new drug product and/or drug containing products and combined therapies
• Responsible for writing scientific reports, papers and technical documents as well as supporting various regulatory filings for new products
• Will work with established QA Team to ensure all procedures are completed and documented to internal company standards and that all 3^rd party labs and vendors meet quality compliance

The qualified candidate will have:

• Proven, hands on skills with HPLC, MS, GC, LC/MS, FTIR, UV-VIS
• Ability to develop, implement and troubleshoot analytical methods
• Experience working with R&D and clinical research material / products
• 5+ years of analytical work and scientific analysis, or pharmaceutical or drug-products or drug-containing development work, can include time in post-doc work
• Strong verbal, written communication and organizational skills
• Capable of managing a laboratory staff, deadlines and a budget
• Knowledge of and training in GLP, GMP, and USP guidelines and regulations
• BS or MS in Chemistry, PhD in Chemistry, Biochemistry or other area of scientific study is a plus

Industry: Chemistry, R&D, Pharmaceutical, Biotechnology, Combination Products, Analytical Chemistry, HPLC, GLP

Job Code: 341-32-MH2322

Recruiter: Lisa

Location: North Carolina

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

Put your education and experience to work in a new job today!

Responsibilities include:

• Directing all of the activities associated with compounding sterile immunotherapy prescriptions for physicians and veterinarians
• Oversight and management of pharmacy technicians 
• Implementing process improvements and reporting
• Working with Sr Management and various client services and operations personnel to ensure all orders and needs are met to 100% satisfaction and within FDA, internal and other external requirements and regulations

The qualified candidate will have:

• BS in Pharmacy, or PharmD (Doctor of Pharmacy) from an accredited school
• Licensed pharmacist in North Carolina (may consider those licensed in other states) with the ability and commitment to gain certification with other states as required
• IV mixture experience (as a daily duty or recent grad with internship)
• Experience with USP Chapter 797 and sterile injectable compounding is a plus
• Strong communications and computer skills is a must for this role
• Passion for staying current on all industry related topics and regulations
• Must have proven ability to work as a team with various departments
• Project management experience of short and long term projects

Industry: Pharmacist, Pharm.D., compounding, IV Mixture, specialty pharmacy, custom compounding, IACP

Job Code: 329-32-MH2322

Location: North Carolina

Recruiter: Chris

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Responsibilities include:

• Leading the incorporation and execution of quality assurance and food safety programs across various plants and manufacturing stores (HACCP, AIB, GMPs, SOPs, training and auditing)
• Developing and maintaining systems to assure compliance to all  QA required documentation
• Documenting and maintain training registry for all employees with both company operated manufacturing site(s), vendors, suppliers and commissary set-ups
• Reassessing the QA plan as there are changes to the program, process, procedure, ingredient, equipment, industry philosophy, technology, etc
• HACCP system, regulatory audits, quality systems review process (QSR), standard operating procedures (SOP’s), incoming ingredient inspections, product scoring, food safety audits,  standardized work instructions
• Oversee plant(s) compliance and interactions with Quality Assurance

 The qualified candidate will have:

• Bachelors degree in Science, Chemistry, Microbiology, Food Microbiology or Food Science is preferred
• AIB course work and Certification is ideal
• Certification and/or training in Food Defense, and able to train at the plant(s) and in the field
• Ideal candidate will have experience with BRC, a BRC Coordinator is a plus
• Proven knowledge of HACCP, GFSI, AIB and various food Quality guidelines
• A minimum of three years in a food manufacturing environment with QA experience
• Two  years facilitating food safety and quality related training

Industry: Food and Beverage, QA, AIB, BRC, HACCP, Food Safety, QSR

Job Code: 311-32-MH2322

Location: North Carolina

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Position is full-time, on-site in North Carolina with full relocation support, great pay and many other benefits and perks.

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Responsibilities include:

• Analyze problems and provide automated solutions
• Provide EDI and applications support and development
• Develop overall system plans to eliminate manual re-keying of data between systems
• Implementation of programs and post implementation support
• Assist users in properly utilizing the systems
• Developing and modifying computer programs with varying degrees of complexity and scope

The qualified candidate will have:

• AAS or technical certification requires, BS degree preferred
• 3+ years experience in IS working with EDI, Extol experience a plus
• Experience with all phases of the development cycle including meeting with users, determining needs and solutions, coding, testing and implementing
• Experience with web services preferred
• Proven experience with RPG400, ILE and Free, CLLE, Query, Operations Navigator, SQL and related tools

Industry: EDI, IS, IT, Extol, SQL, Coding, PC, Websphere
Job Code: 338-41-MH2322
Location: Greensboro, NC
Recruiter: Elizabeth

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

• Ensure 100% up time for all Corporate based systems
• Ensure prompt issue resolution to support the needs of the business
• Responsible for working with IT, Finance, Operations, Marketing and other departments
• Develop and maintain close relationships with technology vendors

The qualified candidate will have:

• 4 -5 years IT and Networking experience
• Prior experience working as a lead or senior network analyst is preferred
• Proficiency with Microsoft Office Suite, LAN /WAN, Cisco Hardware, Back-up and Recovery, ERP, PC Operating Systems and Hardware, Printers, and Storage is required
• Strong analytical and problem solving skills
• Strong team player with solid communications skills

Industry: Network Systems Analyst, LAN / WAN, Cisco, PCI, ERP, Hardware, Routers, PC, Cloud

Job Code: 339-32-MH2322

Recruiter: Elizabeth

Apply directly to: http://www.maxhire.net/cp/?E55F6D361D43515B7D52182B77571D63482D7D  

Don’t wait, apply with The Wellington Group today!
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Qualified candidates for this position will have experience with HPLC as well as sound knowledge of basic analytical and bench chemistry techniques. The chemist is responsible for performing analytical and biological tests in support of in an FDA-regulated environment. 

Responsibilities include:

• Perform analytical chemistry assays
• Operation of various instrumentation including but not limited to UV/Vis, GC and HPLC 
• Exercise strong analytical problem-solving skills
• Conduct testing methodology used to control raw materials, production intermediates, and final products
• Present data from testing and development laboratory activities as required
• Perform work in compliance with GLP, cGMPs, safety and regulatory requirements
• Conduct testing of samples to provide analytical support of R&D activities
• Utilization of chemicals that produce hazardous waste

The qualified candidate will have:

• BS or MS in Chemistry, or related field
• 3+ years pharmaceutical, biological or medical device laboratory experience
• Experience with HPLC, GC, Bench Chemistry and GLP / GMP documentation

 Industry: Pharmaceutical, Biotechnology, Analytical Chemistry, HPLC, GMP, GLP, Medical Device

Job Code: 336-32-MH2322

Location: RTP, NC (local candidates only)

Recruiter: Lisa

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The Senior Engineering Specialist will work with Sr. Management, Site Management, Manufacturing and other internal groups and external vendors to implement tech transfer of products and technology to a new site start-up. Once GMP and internal compliance and operational excellence is established, will be responsible for the ongoing support and management of daily manufacturing needs.

Responsibilities include:

• Responsible for the planning and scheduling of tech transfer, new site start-up and daily operational support of manufacturing
• Support of novel state of the art equipment in lyophilization manufacturing
• Lead, supervise, mentor and develop staff

The qualified candidate will have:

• Requires a Bachelors degree
• 10+ years in lyophilized pharmaceutical product manufacturing is a plus
• Engineering project management in a sterile or aseptic environment with Time-Pressure Filler, Closed Stopper Processing, and Aseptic Manufacturing Principles
• Prior experience in leading, managing, training and mentoring other staff member
• Must be authorized to work in the US

 Industry: Pharmaceutical, Biotechnology, Lyophilization, Aseptic, Engineer, Fill, Finish, GMP

Job Code: 335-32-MH2322

Location: Oregon

Recruiter: Chris

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The Materials Manager will work with manufacturing and the Planning group to implement inventory control systems through the established computer system and visual management techniques. These systems will assist the group in maintaining stated inventory levels for Raw, WIP and Finished Goods while minimizing inventory-carrying cost.

Responsibilities include:

• Responsible for the planning and scheduling of production manufacturing areas
• Negotiate contracts and vendor agreements
• Evaluates vendor reliability; develops new supply sources, as required, in which current vendors and suppliers are inadequate
• Develops policies and procedures for the operation of procurement activities 
• Develops and conducts organization wide training on inventory control and supply topics as needed
• Monitors the cost, schedule and performance aspects of major subcontracts, reviews and approves purchases as authorized 
• Monitor component inventory levels and determine when to expedite/de-expedite replenishments
• Liaison with Manufacturing to ensure level loading of a schedule on a daily and weekly basis that enables the organization to optimize flow and productivity while achieving production objectives
• Evaluates weekly MRP demands and is responsible to determine scheduling deadlines and inventory quantities
• Create daily and weekly schedules within the capacity constraints (product, equipment or labor) as identified for each area scheduled. Schedule effectively to achieve delivery performance and product outdate objectives
• Maintain a thorough understanding of capacity for each product.  Evaluate and monitor manpower requirements, analyze capacity problems
• Maintain visual management boards and required Supply Chain metrics such as Fill Rate, DOS, Outdates

The qualified candidate will have:

• Requires a BA/BS degree
• 7 years direct Supply Chain Planning experience, clinical and scientific materials is a plus
• Familiarity with medical device or pharmaceutical manufacturing preferred, but not required
• APICS Certification Preferred
• Must have excellent communication and negotiation skills.
• Experience with commercial ERP software systems preferred
• Ability to multitask in a fast paced environment
• Proficient in MS Office Word and Project, above average to expert skills in Excel
• Experience with Fishbowl inventory program.

 Industry: Medical Device, Pharmaceutical, Biotechnology, Supply Chain, MRP, Fishbowl, ERP, Excel

Job Code: 332-32-MH2322

Location: RTP, NC

Recruiter: Lisa

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The Equipment Design Engineer will coordinate with Production, R&D, national and global operations, and contractors / suppliers to develop and install new, innovative equipment and process improvements.  Will be responsible to plan, design, manage, outsource, implement and the certification and commissioning of new equipment.  

Responsibilities include:

• Manage the design, development and installation of equipment and processes to meet company goals and future operational needs to reduce SF while reducing waste
• Work with global operations to ensure new equipment meets the space, heat, capacity / power, and other requirements
• Responsible for the graphics design and troubleshooting of all new equipment
• Manage internal and external resources to ensure project goals and timelines are met
• Evaluate processes across manufacturing operations and recommend technological breakthrough solutions

The qualified candidate will have:

•  BS or MS degree in Engineering, Mechanical or Electrical are ideal
•  5 years engineering experience
•  PE or willing to become PE certified
•  Prior experience working with suppliers or in an Engineering or consulting firm
•  Ability to read blue prints, graphics design is required
•  Proficiency with Microsoft Office is required, CAD  or Solidworks experience is a plus
•  Experience working with costing, project budgets and suppliers is ideal
•  Strong analytical and problem solving skills
•  Ability to make presentations to vendors and Sr Management
•  Strong team player with solid communications skills

Industry: Engineer, Design Engineer, Electrical, PE, Commissioning, AutoCAD, Green, innovation, equipment

Job Code: 330-32-MH2322

Recruiter: Chris

Apply directly to: http://www.maxhire.net/cp/?E55E6E361D43515B7D52182B77571D6A482D7D

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