Senior Financial Analyst (Ref# R08-42)
Support the domestic and international marketing and sales teams to achieve corporate objectives, revenue growth and gross margin targets and meet external customer expectations.

• Support domestic and international sales channels and marketing organizations.
• Ad-hoc financial modeling and analyses to support sales and marketing decisions and future business opportunities.
• Develop annual budgets and forecasts for sales and marketing expenditures.
• Develop key metrics for exception pricing, consignment inventory and compensation planning.
• Influence decision making process through sound financial models and judgment.
• Preparation of various analyses to support internal customers.
• Responsible for the annual world-wide planning process.
• Support sales administration, including review of RFPs.
• Ability to interface cross functionally throughout the organizations to gather and synthesize data into financial models and analyses.
• Other job related duties as assigned.

QUALIFICATIONS:

• Bachelors Degree in a business discipline.
• MBA required, CPA a plus.
• 5 plus years of related analytical experience.
• Self-confident, customer-focused individual with a proven ability to produce results in a dynamic, global environment.
• Able to deal in a small fast paced organization.
• Detail oriented, but able to see the "big picture" and able to prioritize and multi task.
• Comfortable with working with a world-wide sales team.
• Not afraid to be a decision maker.
• Strong analytical skills.
• Excellent verbal and written communication skills.
• Excellent computer skills, experience with SAP a plus.

MAINTENANCE PLANNER/SCHEDULER (REF# R08-43)
This position is responsible for the planning and scheduling of all maintenance activities, including spare parts inventory control and requisitioning of parts and services, and overall maintenance work order management. The Maintenance Planner is responsible for assisting with the development of reliability based maintenance strategy based on preventive and predictive maintenance. The position works directly with the Maintenance Supervisor to build a reliable CMMS system and maintenance team. The role of the Maintenance Planner is to improve work force productivity and work quality by anticipating and eliminating potential delays through planning and coordination of manpower, parts and material, and equipment access, and to provide timely support to business unit demands. The Maintenance Planner prepares work plans for individual jobs and assists the Maintenance Supervisor in preparing work schedules and reports.

• Provide detailed work instructions for maintenance and operations to increase plant performance through improved equipment reliability.
• Review work requests daily with Operations and the Maintenance Supervisor.
• Support the execution of maintenance work by receiving, planning, estimating, scheduling and recording required historical data.
• Aide in managing work order backlog; coordinate work orders with the Maintenance Supervisor and support and assist in identifying staffing requirements for Work Orders.
• Coordinate with appropriate department to ensure the availability of facilities and equipment in need of work.
• Assure parts, materials; special tools and equipment are available for orderly and efficient work execution. Report on parts usage, current inventory levels, and usage by department and vendors.
• Write and record Purchase Requisitions in order to maintain the correct inventory levels of parts. Assess and maintain appropriate parts inventory levels.
• Prepares and distributes accurate reports to upper management on Maintenance Key Performance Indicators including, but not limited to, the following: work order backlog, mean time between failures (MTBF), mean time to repair (MTTR), number of planned vs. emergency jobs and percentage completed.
• Assist in further development and manage a comprehensive Preventative Maintenance Program.
• Back up for Maintenance Supervisor in the event of vacations or other incidents where he is unavailable.
• Routinely monitor machines or equipment to detect malfunctions and discusses machine operation variations with supervisors or other maintenance workers to diagnose problem or repair machine.
• Complete aseptic training and be qualified to enter the sterile processing areas.
• Report on parts usage, current valuation of parts inventory and other inventory control reports as required.
• Conduct regularly scheduled cyclic inventories.
• Maintain purchase records for items or services purchased, cost, delivery times and quality of those goods received.
• Organize activities involved with purchasing materials and services such as equipment, tools, parts, and supplies in support of the Tool Crib.

QUALIFICATIONS:

• Associates Degree or Technical Degree in Engineering discipline required. Bachelor’s Degree in Mechanical or Electrical Engineering preferred.
• A minimum of 5 years experience in industrial maintenance or a similar field.
• Should possess a strong knowledge in various mechanical/electrical systems and be able to apply that knowledge to Osteotech systems and production equipment.
• General knowledge and experience with basic 110 volt electrical systems, such as transformers and wiring, and electrical and electronic components of machinery.
• General knowledge and experience with basic piping and plumbing systems.
• Should be able to use internet search process and have an understanding of common computer programs. Should be proficient in MS Excel.
• Excellent analytical and problem solving skills.
• Must have maintenance planning and scheduling experience, as well as spare parts inventory control experience.
• The ability to interact professionally with other departments.
• Have a sense of urgency and the drive to get the job accomplished with minimal equipment downtime. Demonstrated ability to function well under pressure and willingness to expend effort required to meet schedules/deadlines.
• Demonstrated ability to work autonomously in self-directed team environment and to effectively lead meetings. Must be able to complete assigned tasks with minimal supervision.

ERP Database Support (Ref# A08-54)
Administrate the Master Records database within the various Enterprise Resource Planning (ERP) systems and general support of the IT department.

ERP Master Records Administration

• Lead the administration of the master records within all ERP’s (ROSS, SAP, TMS), including:
  • Assist in the development of procedures and maintenance to support:
    • Material master
    • Vendor master
    • Customer master
    • Other minor master tables
  • Serve as the company’s primary contact for processing all new and updates to the ERP master records.
  • Assist internal business customers in the understanding of the required and optional elements of the master tables.
  • Participate in internal and external audits with scope of responsibilities.
  • Identify process improvement opportunities through participation in department and team meetings.
  • Provide regular reports on the issues and concerns related to the master records including:
    • Validation results on accuracy and completeness of existing records
    • Open and unresolved requests in the system
    • Other metrics on system (e.g. avg. time to close, # of requests, etc)
  • Research and Understand the interdependencies of the master data, convey this information to master table owners as an input into their decision making process.

QUALIFICATIONS:

• H.S. Dipolma or equivalent required.
• Some college or business school a plus.
• Strong interpersonal skills
• Proficient in Microsoft Word, PowerPoint, Excel.
• Prior SAP experience a plus.
• Strong organizational and time management skills.
• Ability to work overtime when necessary
• Strong sense of urgency.
• Ability to multi-task.
• Detail oriented.
• Flexibility.
• Excellent written and verbal communication skills.
• Team player.

Manager, Demand Planning (REF:R08-06)
Lead the Sales & Operations Planning Process to ensure the right product is available at the right time in the right quantities to achieve Inventory Management Objectives and reduce obsolescence.

Responsible for managing the development and execution of the master demand plan. Support Sales and Marketing by gathering demand inputs and generating forecasts for review. Link Sales& Marketing, Finance, Operations and Supply Chain by communication of forecasts, projected inventory levels and demand plan. Input demand planning data into company's ERP system. Provide management with key reports and performance to metrics. Communicate status of back orders and projected relief date, monitor demand of products vs plan and recommend ship dates for demands in excess of plans. Lead Supply Chain monthly Sales &Operations Planning Meeting. Lead organization in execution of delivery of finished good products and launch of new products.

• Own the S&OP process, lead and facilitate monthly S&OP meeting.
• Prepare proposed demand forecast for review and approval by Sales & Marketing, Supply Chain, Finance and Operations. Actively communicate inputs, analysis and outputs at monthly S&OP meetings.
• Provide business leadership for coordination of resources for new product introductions or major product line changes.
• Develop and implement processes and systems improvements for Supply Chain organization using analytical approach, supported with appropriate data analysis.
• Lead Sales and Operations Planning (S&OP) Planning process, ensuring development of demand plans and levels of inventory to support Company's revenue objectives.
• Report projected impact of demand plans on inventory levels.
• Review and release backorders, communicate with key stakeholders regarding anticipated delivery of those products.
• Perform inventory allocations.
• Work with Operations to assign delivery dates for orders that are in excess of approved plan.
• Drive resolution on material and capacity issues that may impact demand plans.
• Track and report performance metrics on a weekly/monthly basis.
• Partner with Sales & Marketing, Operations, Product Development and Finance to develop and implement Supply Chain strategies.
• Forecasting, capacity and business planning, distribution and field inventory management.
• Accountable for managing product supply through customer delivery and developing strategies for demand planning to achieve business objectives.
• Provide leadership and Management for Demand Planning Analyst.
• Analyze and evaluate data from key functional areas, supporting decision making processes.
• Develop recommendations regarding safety stock based upon balance of cost, customer satisfaction and management objectives.
• Report accuracy of forecast versus actual shipments and production output versus commitment.
• Other duties as required.

QUALIFICATIONS:

• Bachelor's degree required, major in engineering, business, marketing, supply chain, operations or materials management preferred. MS or MBA a plus
• Requires broad knowledge of forecasting, product distribution, inventory control, manufacturing processes and master scheduling.
• Minimum ten years demand planning, forecasting and sales planning experience in areas such as Material Planning, Supply Chain, Operations, or Production Scheduling.
• Minimum of five years master planning experience in a fast paced, manufacturing environment is necessary.
• Minimum of five years of managerial experience.
• Must have a clear understanding of manufacturing processes and manufacturing planning and control systems.
• Experience with forecasting and inventory planning, report writing, business intelligence and ERP software packages.
• Ability to manage and motivate direct reports.
• Proficient skills in PC and Microsoft Office applications.
• Prior pharmaceutical or medical device or other regulated industry experience.
• Strong analytical, communication, interpersonal, presentation and time management skills.
• Ability to react to situations with a sense of urgency.
• Organized, detail oriented and methodical.
• History of leadership roles in assimilation, coordination and development of plans to achieve total customer satisfaction.
• Strong project management and consulting skills with the ability to influence, work effectively and implement solutions in a team environment.

Sr. Process Improvement Specialist (REF: R07-62)
The Sr. Process Improvement Specialist supports the SBU providing project management, tracking and implementation of process improvements in alignment with company and departmental objectives.

• Develops and administers Global Procedures and Policies for Operations.
• Provides project management and tracking for process improvements and cost reduction initiatives.
• Creates and administers training plans.
• Management delegate for various meetings.
• Leads, performs and completes Change Control, SOP creation and revision, Deviations, Incident Reports and Investigation Reports.
• Prepares responses to various audits.
• Read, understand, and follow applicable standard operating procedures (SOP).
• Identify and implement continuous improvement strategies.
• Chair/Contribute as a team member on continuous improvement teams.
• Support new product development and production.
• Knowledge of basic anatomy and tissue identification.
• Knowledge of product codes.
• Ensure documentation is compete and accurate.
• Adhere to company code of conduct, policies and practices.
• Arrive at work and other work-related functions on time as scheduled.
• Perform other job-related tasks as required by supervision/management.

QUALIFICATIONS:

• College Degree; Life Sciences or Technical Degree preferred.
• 3 to 5 years of project management experience in Tissue Banking, Medical Device Manufacturing, or Pharmaceutical Manufacturing.
• Knowledgeable of cGMPs, AATB, GTP, and ISO requirements.
• AATB CTBS preferred.
• Strong computer skills, including Word, Excel, Visio, Access.
• Strong organizational skills.
• Excellent written and communication skills.
• Detail oriented, team and leadership skills.
• Demonstrated ability to drive multiple projects simultaneously to achieve results.
• Displays a positive attitude related to internal and external relationships%.

Quality Engineer (REF: R08-15)
Plans, develops, maintains, and manages portions of the Quality Control program for Osteotech, Inc., with direct involvement with Regulatory Affairs, Product Development, Validations, Operations, Sales and Marketing, and Purchasing in matters concerning Quality control inspection, supplier qualification, validation, product stability, and documentation. Ensures that products released to the market meet the desired quality specifications and attributes through engineering analysis and testing. Assure all corporate standards, Code of Federal Regulations, American Association of Tissue Banks, and other standards and regulations are met.

• Participate in the development, planning, implementation, and maintenance of related methods and technology applications that meet the required standards of aseptic and terminally sterilized bio-pharmaceutical production.
• Support the design and development of new products and participate in process design and development activities. Responsible for preparing the quality plan and determining the test methodologies to be used for routine quality control of products. Coordinates testing with Osteotech Quality Control laboratories or external testing laboratories for product safety and or other required tests.
• Interact with Product Development and Operations to assure statistically based quality systems intended for use in the quantitative measurement of process variability.
• Participate in risk analysis for product designs and processes. Responsible for improvement to products through the results of failure analysis and recommend design changes based on testing or regulatory agency requirements.
• Ensure verification testing of medical devices using proven methods under design control guidelines.
• Review and approved inspection plans, routers and product drawings.
• Review/approve products and process change controls and specifications.
• Responsible for standardizing and optimizing product testing and inspection procedures and supervise the QC inspection group, as applicable.
• Contribute to the development of systems intended to reduce individual and total process variability.
• Assure process control by contributing to the development and review of equipment and process qualification and validation protocols.
• Develop and maintain systems to track and report trends in key quality system indicators.
• Responsible for maintaining the non-conformance system and design systems for tracking and trending of non conformances. Apply problem solving techniques (e.g. root cause analysis) to resolve non-conformance and customer complaints. Assess and report on level of compliance and other areas of potential risk to Company business.
• Assure compliance with federal regulations and internal corporate controls and standards through management of assigned responsibilities of the quality system.
• Provide assistance in regulatory submissions and issues by providing technical information and attending project meetings as requested and/or appropriate.
• Responsible for preparation of departmental training plan and training of personnel in inspection techniques and relevant Quality Control procedures, as applicable.
• Other duties as assigned.

QUALIFICATIONS:

• Bachelor of Science degree in a scientific discipline or engineering degree, ASQ certification: CQE
• Minimum of eight (8) years of professional managerial experience in a quality engineer role preferable in a medical device, pharmaceutical, biologics or aseptic processing company.
• Fluent in cGMPs, AATB, GTPs, ISO and FDA regulations and compliance.
• Knowledge of industry test standards e.g. ASTM, ISO, USP etc.
• Well organized with strong attention to detail.
• Experience with multiple types of manufacturing product lines, water systems, and sterilization.
• Demonstrates effective collaborative leadership, and outstanding interpersonal skills at all levels (both internally and externally).
• Strong computer skills, including Word, Excel, Access and statistical software.
• Excellent technical writing and verbal communication skills.
• Ability to react to situations with "a sense of urgency."

Senior Process Development Engineer(REF: SPDE)
Responsible for providing technical support to design, develop, improve and validate processes to launch new products, reduce costs, improve product quality, and reduce cycle time. Perform engineering studies for process development, write SOPs, validation protocols and reports.

• Work with scientists to understand processes and identify critical scale-up issues. Develop and safely execute scale-up plans to transfer processes to manufacturing.
• Provide guidance to scientists regarding design concepts and specification requirements to cost effectively utilize production equipment and manufacturing techniques.
• Work with vendors to identify and develop, if necessary, suitable equipment for new and / or improved processes. Evaluate equipment performance, including operational tests as required. These will be pre-purchase tests, either at the vendor site or with loaned equipment.
• Participate in and manage (as required) prerelease product builds. Develop protocols and compile technical data/ report.
• Manage projects to meet Quality System requirements and aggressive deadlines while employing good manufacturing practices.
• Adopt a process ownership methodology for critical processes including utilization of techniques such as FMEA, SPC, DOE, Process Capability Analysis, engineering studies, and time and events schedules.
• Demonstrate ability to comprehensively complete required paperwork in accordance with cGMP, QSR, and SOP.
• Support the improvement of processing steps for new products. Perform engineering studies and create document to support any process changes.
• Perform the correct, safe operations and maintenance of production equipment.
• Responsible for training technicians in transfer of product into manufacturing.
• Responsible for implementing process changes to improve quality and reduce costs. Utilize Six Sigma methodology to analyze manufacturing process capability, to identify problems and opportunities for improvement, and to develop and implement engineering solutions.
• Support micro, chemical and environmental testing, trending, and investigations with root cause analysis and corrective action implementation.
• Provide the leadership to evaluate material compatibility for use in production, create specifications, and validate for production use as required.
• Support R&D for introduction of new materials, products, and chemical processes.
• Adhere to company code of conduct, policies, and practices
• Perform other tasks as required by the supervisor / management.

QUALIFICATIONS:

• B.S. in Industrial or Mechanical Engineering with 5 to 10 years of experience in medical or pharmaceutical industry. M.S. degree or Ph.D. with min 5 years of experience in areas listed above. Six Sigma Training preferred. Must have a proven track record in developing new technology, processes, & equipment with minimal supervision.
• Detailed understanding of and demonstrated ability to conduct validation activities (IQ/OQ/PQ).
• Ability to plan and schedule multiple projects and tasks. Demonstrated ability to manage and drive tasks to schedules within a team environment. Ability to act independently and make independent decisions when needed.
• Familiar with Design of Experiments to evaluate product performance.
• Excellent deductive reasoning and problem solving skills.
• Knowledge of cGMP's. The ideal candidate should be well versed in the documentation needs required to support FDA filings.
• Demonstrated proficiency in:
  • Statistical software (e.g. SAS JMP)
  • MS Windows OS, MS Office (Excel. Word, PowerPoint).
  • Microsoft Project or equivalent.
  • CAD proficient using any 3D or 2D Engineering package such as AutoCAD, ProE, or Solidworks.
  • Desired: Programmable Logic Controller or machine interface programming experience.
  • Desired: Mechanical Testing Knowledge (Fatigue, Creep, Tensile, etc.)
• Experience designing assembly and test fixtures and working with suppliers.
• Understanding of product costing techniques.
• Excellent communication and presentation skills. Comfortable communicating with all levels of the organization.
• Six Sigma Training preferred.

Processing Technician, 2nd Shift (REF: PTG)
In this position, you will be responsible for all phases of direct physical processing and packaging of DBM with Additive and D- Min tissues.

• Adhere to Company code of conduct, polices and practices.
• Demonstrate ability to comprehensively complete required paperwork in accordance with Good Manufacturing Practices and Standard Operating Procedures.
• Perform grinding/milling, demineralization, freeze-drying, filling/bottling and packaging of DBM with Additive and D-Min tissues according to client processing requirements and specifications.
• Participate as required in continuous improvement and margin improvement projects.
• Perform cleaning and environmental monitoring according to Standard Operations Procedures.
• Participate in post-shutdown cleaning activities as required.
• Demonstrate ability to read, understand, and follow procedures.
• Perform other tasks as required by supervisor/management.

QUALIFICATIONS:

• College degree or 4 years experience in related field is preferred.
• Knowledge of GMPs, AATb and GTP requirements.
• Computer competency (MS Office Suite)
• Must be able to lift from 60-75 lbs.
• Must be dexterous, able to stand for long periods of time with the ability to bend/reach and be comfortable with repetitive motions.
• Must be comfortable with working in a wet and confined environment and high noise activity.