TDS Chemist I

Technical and Development Services (TDS)

Summary of Position:
The Technical and Development Services (TDS) Chemist I is a technical resource in developing and validating the quality control methodology necessary to support commercialization of pharmaceutical products. The TDS Chemist I is responsible for performing the bench chemistry testing necessary to install the analytical methodology to support new projects and initiatives at Norwich. The TDS Chemist I will work under the supervision of senior chemists in the installation of quality control methodologies and performing laboratory work supporting development, transfer, validation, and/or qualification for methods related to analyzing raw materials, semi-finished/finished products, and stability.

Responsibilities:

• Assist in the execution of the installation work for all quality control methods necessary for commercialization of pharmaceutical products. This includes laboratory experimentation for validation/qualification/transfer requirements, equipment acquisition/installation, reference standards/reagents, Techs-NM, drafting methods/reports, training, and other steps as required.
• Perform hands on laboratory bench work to develop, optimize, and troubleshoot analytical methods for testing raw materials and products (semi-finished and finished) supporting the installation to the Norwich QC laboratory or other laboratory sites as required.
• Assist in authoring method validation/qualification/transfer protocols compliant with cGMP regulations, industry standards, and customer direction and consistent with the developed installation strategy and project scope.
• Assist in authoring method development/validation/transfer/qualification reports suitable for customer and regulatory submission.
• Conduct lab bench work as necessary for analytical method validation, transfer and compendial verifications for raw materials and products (semi-finished and finished).
• Provide technical assistance toward troubleshooting, method development and validation difficulties. Works senior chemists to efficiently work through problems with method installation until root cause is determined and solution is found.
• Complies with laboratory procedures and SOPs. Follows written and verbal direction from senior chemists to execute tasks and work independently with a minimum of supervision.
• Interacts with customers as required to obtain information, influences customer decisions, and drives the project forward. Works as the analytical expert contributing member on project teams supporting new business projects.
• Performs administrative functions, materials sourcing, vendor inquiries, exploration of new technologies as required to effect rapid and efficient project progression.
• Works efficiently, minimizing distractions and manages time to accomplish work by expected deadlines. Provides regular reports on progress to leadership and during team meetings.
• Work in compliance of all US and international regulatory agencies and compliance requirements as they relate to analytical testing.
• Travel as required to outside laboratories for the purpose of receiving training from a qualified laboratory or providing training to a receiving laboratory. International travel may be required.

Qualifications:

• BS in Chemistry or related science. (1-2 years experience in pharmaceutical analytical chemistry preferred)
• Familiar with GMP concepts
• Academic exposure and familiarity with the majority of the following: HPLC, GC, UV-Vis spectroscopy, atomic absorption, titration, FTIR, and wet chemistry.
• Experience with data acquisition systems such as TotalChrom, ChemStation preferred.
• Strong analytical aptitude, ability to comprehend and apply scientific theory and analytical techniques to solve problems.
• Advanced computer skills specifically in Microsoft Word, Excel.
• Refined written and verbal communications and presentation skills.
• Strong organizational skills, ability to manage and complete assigned projects on time.

Decision Making

• The TDS Chemist I has authority to perform work as assigned supporting the installation of quality control methodology into NPI. This includes following method techniques, choosing appropriate materials, drafting test plans, and executing laboratory testing.

Customer Service

Core Responsibilities:
Customer Service is responsible for the management of a variety of administrative, business and operational functions necessary to run NPI Business efficiently. This includes, but is not limited to:

• Involvement in Contract Negotiations an addendums ensuring NPI has the capability or has a strategic plan to ensure capability is available when required.
• Coordinating internal contract review, quality contract review, SLEA agreements, as well as all updates.
• Provides all Internal Departments (i.e.: Project Managers, QA, Purchasing, Materials Planning, etc.) with business requirements needed to support all projects.
• Initiating and providing all abnormal demand customer responses for quotations for services that are above and beyond commercial forecast.
• Ensures project purchase orders and/or written approval is received prior to labor and resources being applied towards any given project.
• Confirm Revenue Projections and weekly updates with Planning.
• Assist finance in addressing customers A/R issues.
• Provides progress reports to upper management on key business metrics, customer satisfaction status, S&OP goals, and/or internal opportunities for improvement.

The main goal is to provide excellent customer service by acting as a liaison between NPI and the Customer – ensuring the best interest of both NPI and the customer are being met. This includes, but not limited to:

• Being the primary point of contact and Customer Advocate.
• Ensures that all aspects of the Customer Account are being met or exceeded.
• Continuous communication with Customer for projects, issues, status, and reviews.
• Providing Customer Support in all aspects of project scopes: Creates and maintains Critical Path Schedules as appropriate.
• Main interface between Customer and Internal Departments.

Customer Service plans, develops, & executes plans that have a direct effect on both the Customer’s and NPI’s business program. They must be able to cope with conflicting points of view, function under pressure, and demonstrate discretion, integrity, fair-mindedness, and a persuasive, congenial personality. This includes, but not limited to:

• Coordination of internal and external resources required to meet Customer Contracts/SLEA agreements.
• Assist (Troubleshoot) Logistics in driving performance measures to Sales Plans and Sales Quota when needed.
• Coordinate Customer Interface (Both Internal & External) on technical problems affecting deliverables.
• Participates and/or leads Customer Capacity discussions as necessary.
• Handles all follow-ups, issues, conflict, resolution to ensure all needs both internally and externally are met.

Customer Service is expected to understand, meet, and exceed their customer’ requirements while adhering to parameters set forth by NPI. This includes, but is not limited to:

• Management and Lead for Customer Performance reviews, including QBR (Quarterly Business Reviews) as required.
• Coordination of Customer Visits.
• Customer Scorecards – Publish results and initiate follow-up actions as required.
• Meets and/or exceeds timing for Customer Projects.

Core Competencies:

Business & Management Principles (Understanding the Business) – To include Operational, Financial, Growth Expectations

• Administer, direct and review program area(s) to meet organizational objectives and goals.
• Analyze statistical data and reports to identify and determine causes of problems and develop recommendations for improvement. (Ex. Consistent Low Yield – utilize trend data to help define top issues and work with internal personnel to understand root-cause and correct).

Management processes and techniques / Achieving Results

• Business and management principles involved in long term strategic planning (S&OP), resource allocation, production methods, and coordination of people and resources for Abnormal Demand.
• Tell when something is wrong or is likely to go wrong – take a proactive approach to correction/resolution.
• Arrange things or actions in a certain order or pattern according to a specific rule or set of rules.
• Gather and interpret data, reach logical conclusions and present findings and recommendations.

Meeting Facilitator

• Perform Lead-Role in all applicable meetings – lead team through set of discussions.
• Set & Publish Agenda (TOR) prior to meeting, thereby enabling entire team prep time if needed.
• Introduce all parties.
• Keep meetings on task and focused by utilizing action logs, ensuring follow up action items are completed by responsible parties.
• Ensure all NPI parties are prepared prior to meeting with customers.
• Difficult Topics need to have the “NPI Team” clearly understanding the company’s position & presentation prior to meeting with the customer.
• Shift conversations away from unproductive tangents.
• Always put NPI’s “best foot forward”.

Serving the Customer

• Delight customers, above and beyond the call of duty.
• Has intimate knowledge of the customer’s needs.
• Empathize with the customer’s situation.
• Communicate clearly, both written and verbally.
• Handle complaints, even when handling unpleasant customers in a professional manner.
• Accurate and with eye for detail.
• Executes all matters in the best interest of both customer complaints/issues.

Teamwork

• Attempt to understand positive and negative aspects, adjusting actions in relation to others’ actions.
• Monitor progress of program objectives that affect the quality and level of services provided and the program’s success.
• Communicates goals and objectives to the team.

Interpersonal and Communication Skills

• Provides help and advice to customers, using the organizations products or service.
• Communicates effectively in writing as appropriate for the needs of the audience.
• Talks to others to convey information effectively.
• Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
• Being aware of the others’ reactions and understanding why they react as they do.

Leadership and Personal Effectiveness

• Uses logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
• Identifies complex problems and reviewing related information to develop and evaluate options and implement solutions.
• Apply general rules to specific problems to produce answers that make sense.
• Ensure each Objective is clearly understood by all applicable parties.
• Publish all Action Items and Follow-ups.

Quality Control Laboratory Chemist I

Job Duties and Responsibilities:

The Quality Control Chemist 1 performs routine testing to assess the conformance of raw materials, finished products, and stability samples to predetermined product specifications. The Quality Control Chemist 1 may also test samples to support cleaning verification, process or method validation, or other samples as required to support the manufacturing, packaging, or product development effort. The Quality Control Chemist 1 performs testing in conformance with approved procedures and accurately and concisely documents and reports experimental steps and results. The Quality Control Chemist 1 has a basic knowledge of SOPs and GMP regulations as related to the pharmaceutical quality control laboratory.

• Perform routine sample analysis requiring general laboratory skills such as weighing, pipetting, titration, and basic operation of laboratory instrumentation
• Comprehend and follow approved test methods accurately in the performance of sample analysis
• Performs analysis with a practical understanding of the test procedure and instrument operation
• Applies knowledge, education, experience, and training in cooperation with technical resources to troubleshoot and resolve problems
• Custodian of laboratory systems and is proactive in implementing system improvements
• Uses available software to control instrumentation, collect data, process and calculate results, and report results
• Perform testing to evaluate physical characteristics of raw materials and finished products
• Work independently with minimum of supervision
• Calculates results and assesses conformance with specifications and historical data
• Notifies supervisor immediately of nonconforming data or unexpected occurrences

Responsibilities:

• Organize work schedule to complete assigned tasks efficiently and on schedule
• Provides training to new analysts on practiced techniques
• Maintain accurate record of analysis and perform documentation to company standards
• Perform routine maintenance and calibration of laboratory equipment
• Prepare test solutions, reagents, and samples used in analysis
• Applies chemistry or related scientific education to work and thought processes
• Familiar with department and plant systems and effectively operates within systems to achieve desired results
• The Quality Control Chemist 1 performs all of the duties outlined for the Senior Technician as required
• Other duties as assigned by supervisor

Qualifications:

• BS in Chemistry or related field or college chemistry coursework plus 5 years laboratory experience
• Strong oral and written communication skills
• Proficient in computer use (Word, Excel, internet) with ability to learn new computer applications
• Ability to comprehend and follow standard operating procedures and test methods
• Strong analytical aptitude, scientific judgment, and operates with a sense of urgency in a fast paced environment
• Strong organization, communication, and interpersonal skills

Skills:

• The Quality Control Chemist 1 minimally possesses basic skills in the performance or operation of five or more of the following within 1 year of service
• High Performance Liquid Chromatography (HPLC) (multiple modes)
• Gas Chromatography (GC)
• Dissolution
• Atomic Absorption Spectroscopy (AA)
• UV-Visible Spectroscopy (UV-Vis)
• Titrations and Karl Fischer
• Identification by FTIR, Raman, and wet chemistry techniques
• USP/EP content and requirements
• Validation (equipment and methodology)
• Metals by USP/EP wet chemistry methods
• Numerous USP/EP wet chemistry assay methods
• Industry guidelines related to job function (ICH, FDA, USP)
• Manufacturing Process Development and validation
• Statistical analysis (trending, SAS, APR)

Decision Making:

• Escalates lab/testing issues to his/her Manager
• Provides input for method development decisions as appropriate
• Provides input for the writing/ revision of SOP’s and QAT’s as appropriate
• Provides input into laboratory investigations as appropriate

Practice Compliance Department Manager

Responsibilities include managing key portions of the Company's Corporate Compliance function.

Roles and Responsibilities:

• Independently managing oversight of domestic and international audits / inspections that ensure compliance with the FDA and other worldwide health authority regulations / guidelines, site SOP's, protocols, and industry standards and marketing authorization.
• Applying developed skills to assure management that the facilities and building, equipment, personnel, organization, methods, procedures, records, reports, and / or controls are in conformance with applicable regulations.
• Applying developed skills to assure monitoring and management of clinical studies are conducted in accordance with applicable regulations.
• Applying developed skills to assure adherence and application of GMP, GLP, GCP and CRP practices.
• Responsible for development and dlelivery of formal compliance training through various methods; including formal presentations, on-line training, workshops and written materials.
• Responsible for maintaining strict ethical, legal adherence and confidentiality at all times.
• Support the development and approval of Quality Service Agreements and assure adherence during site audits.
• Provides recommendtaions for corrective actions and tracks corrective action commitments derived from audit observations.
• Integrating compliance controls into the scope of existing business practices company-wide.
• Maintain professional expertise and knowledge of local and international regulations.
• Responsible for oversight and management of Validation activities.
• Review and approve Validation Development reports and Final Summary reports.
• Responsible for serving as an active member of the Change Management Board to ensure that all changes to critical systems are evaluated for validation requirements.
• Provide technical expertise in all aspects of validation principles.

Qualifications / Key Criteria:

Education and Experience

• PhD or MS degree in a scientific or health-related field is required with at least 8 - 10 years industry experience and 4 - 6 year auditing experiene in pharmaceutical industry.
• Excellent interpersonal and communication skills are required. In addition, candidate must be organized with excellent attention to detail.
• Candidate must demonstrate ability to work independently, and posses excellent project management skills.
• Candidate must demonstrate appreciation of need to maintain confidentiality of audit process and internal investigations.
• Candidate must demonstrate willingness to travel (Domestic and International) 25% annually.

Project Manager

Technical & Development Services (T&DS)

Roles and Responsibilities:

• Performs as a Project Manager (PM) for new initiatives start ups, major business initiatives, and major commercial projects/improvements. The PM leads and coordinates the transfer process from the time of contract approval to turnover to production & customer service (approximately validation). The PM leads the cross-functional team to bring in new products, equipments, and processes into the facility. Members on the cross-functional tam will typically include: QA Methods, QA Systems, QA Standards, Process Engineer, Validation, Mfg. representative, Pkg. representative, Logistics/Sourcing and Safety. Typically, the PM will be managing 2-4 projects (dependant on complexity) at a time by managing multiple priorities.
• Develop, maintain and meet transfer/start up schedule. Microsoft Project is used as the primary software tool to aid in this activity. PM is to help identify and remove barriers to successful execution.
• Perform as primary interface for customer. PM is responsible to insure an excellent relationship with the customer is maintained and that the customer needs are being met. PM is responsible as primary conduit for communications and to coordinate/to be cognizant of ‘technical experts’ discussions across the customers.
• Ensure Project Budget is met. Approve project spending. Secure Capital funding as required. Manage cost and income for the project.
• Ensure that contract deliverables are met on time. Manage project scope. Adjust project scope as necessary to meet customer needs, redefined the scope and costs as necessary.
• Develop controversial expertise (working knowledge, but not expert) in all phases of standards, SAP requirements, plant systems, etc.
• Occasionally help out in other areas of the project which may include equipment installation, IOQ, validations, etc.
• Ensure project meets site requirements (Tech-NM, Validation Change Control, Safety, Environmental, Compliance, Training, Spare parts, Preventative Maintenance, Turnover Criteria to Production & Customer Service etc.)
• Ensure short and long term project plans and goals are in place and are aligned with Site business objectives and Department goals.
• Interfaces with the Process Engineering, Facility & Equipment Engineering, QC, QA, Manufacturing Operations, Packaging Operations, Logistics, and Customer Service Staff to align resources to deliver project expectations. Builds mastery in the assigned areas in self and others.
• Ensures that safety and efficiency of products manufactures at Norwich Pharmaceuticals, Inc. are never compromised.
• Ensures assigned CAPAs eliminate root cause and get completed ton time.
• Supports Agency and Customer quality audits.

The primary role of the Project Manger is to ensure excellent relationship with the customer and to ensure the project meets deliverables on required timing by coordinating the work of many resources. The PM is not expected to master all phases of technical transfer.

Qualifications / Key Criteria:

Qualifications:

• Education: Bachelor of Science/Bachelor of Engineering (BS/BE) or equivalent combination of experience and education.
• Experience: 3-5 years of project management experience in a Manufacturing and/or Packaging Facility

Decision Making

• Review and approve documents as required.
• Provides input for product and material release/reject decisions made by the Quality Assurance Organization as needed.
• Determines required technical training and champions the resources to deliver against specific training plans.

Process Development Technologist

Technical & Development Services (T&DS)

Roles and Responsibilities:

• Sets up, operates, cleans, & maintains pilot scale equipment
• Identifies key process parameters and their impact on product quality.
• A technical resource for the T&DS Pilot Scale Group, who ensures the application of technical knowledge and problem solving approaches.
• Uses statistical methods to determine in-control/out-of-control processes.
• Participates in the development of solutions and action plans to address quality and production improvements.
• Implements process changes/improvements.
• Develops training material for the pilot scale process equipment.
• Supports integration of new business utilizing current equipment and work processes.
• Executes Design of Experiments.
• Performs process mapping and assessment to eliminate waste, improve efficiencies, and propose changes to customers that “add value” to their product.
• Insures correct, up-to-date technical information is readily available and used by the operating teams.
• Supports scale-up activities, moving products from smaller scale to commercial scale.
• Interfaces with the Project Management, Facility & Equipment Engineering, QC, QA, Manufacturing Operations, Packaging Operations, Logistics, and Customer Service Staff to align resources to deliver process definition and capability.
• Builds mastery in the assigned areas in self and others.
• Sets and enforces standards (cGMPs, Safety, Delivery, Cost) and incorporates expectations in daily work.
• Ensures that safety and efficacy of products manufactured at Norwich Pharmaceuticals, Inc. are never compromised.
• Ensures assigned CAPAs eliminate root cause and get completed on time.
• Supports Agency and Customer quality audits.

The primary role of the Project Manger is to ensure excellent relationship with the customer and to ensure the project meets deliverables on required timing by coordinating the work of many resources. The PM is not expected to master all phases of technical transfer.

Qualifications / Key Criteria:

Qualifications:

• Education: Associates degree in Science or Engineering Technology or equivalent combination of experience and education
• Experience: Minimum 5 years of experience working in Rx Manufacturing Environment.
• Excellent written and verbal communication skills
• Strong Problem Solving Skills
• Flexible Work Schedule- days and shifts will change week to week

Desired Qualifications:

• Knowledge of DOE using statistical software such as JMP and MiniTab
• Operational experience with granulation, blending, compression, encapsulation, and coating equipment.
• Understanding of analytical testing procedures and the results reported.
• Understanding of the theory of the various solid dose manufacturing operations

Process Engineer, Packaging Engineer, Process Engineer Pilot Scale

Date: February 2009

Technical & Development Services (T&DS)

Roles and Responsibilities:

• A technical resource for the Operations Department, who ensures the application of technical knowledge and problem solving approaches.
• Identifies key process parameters and their impact on product quality.
• Uses statistical methods to determine in-control/out-of-control processes.
• Leads the development of solutions and action plans to address quality and production improvements.
• Ensures process changes/improvements do not negatively impact process performance or product quality.
• Is involved in initial room designs, equipment specifications, etc. as part of new business initiatives.
• Develops and executes equipment installation and operational qualifications. Develops and executes process validations.
• Ensures correct up-to-date technical information is readily available and being used by the operating teams.
• Assist in the development of training material.
• Supports integration of new business utilizing current equipment and work processes.
• Leads and executes Deign of Experiments.
• Performs process mapping and assessment to eliminate waste, improve efficiencies, and propose changes to customers that “add value” to their product.
• Ensures correct, up-to-date activities, moving products from smaller scale to commercial scale
• Ensures short and long term project plans and goals
• Interfaces with the Project Management, Facility & Equipment Engineering, QC, QA, Manufacturing Operations, Packaging Operations, Logistics, and Customer Service staff to align resources to deliver process definition and capability.
• Builds mastery in the assigned areas in self and others.
• Sets and enforces standards (cGMPs, Safety, Delivery, Cost) and incorporates expectations in daily work.
• Ensures that safety and efficacy of products manufactures at Norwich Pharmaceuticals, Inc. are never compromised.
• Ensures assigned CAPAs eliminate root cause and get completed on time.
• Supports Agency and Customer quality audits.

The primary role of the Project Manger is to ensure excellent relationship with the customer and to ensure the project meets deliverables on required timing by coordinating the work of many resources. The PM is not expected to master all phases of technical transfer.

Qualifications / Key Criteria:

Qualifications:

• Education: Bachelor of Science/Bachelor of Engineering (BS/BE) or equivalent combination of experience and education.
• Experience: 3-5 years experience working in a Rx Manufacturing and/or Packaging facility.

Decision Making:

• Review and approve Change Controls and Equipment Qualifications.