Position Title: Quality Control Laboratory Chemist 2

Business Unit: Operations

Job Duties and Responsibilities:

Perform Duties and Responsibilities:

• Perform routine and complex sample analysis requiring refines laboratory skills, technical prowess and astute observations
• Comprehend scientific principles and follow written test methods accurately in the performance of sample analysis
• Performs analysis with expertise and understanding of scientific principles of one or more of the following: HPLC, GC, Dissolution, USP/EP raw material testing, wet chemistry, spectroscopic, techniques, or microbiological techniques
• Applies theoretical knowledge, education, experience, and training in corporation with technical resources to troubleshoot and resolve problems
• Provides laboratory leadership and effects positive change through system ownership
• Function as the laboratory representative on multi-department project teams
• Communicate with clients, contactors, and regulatory agents as required
• Uses advanced software functions to control instrumentation, collect data, process and calculate results, and report results
• Provides leadership and guidance to junior staff and coordination of work efforts for junior staff in relation to project work as assigned
• Develops and authors laboratory procedures as assigned
• Works independently and seeks supervision when requires
• Calculates results and interprets data in relation to project objectives
• Notifies supervisor immediately of non conforming data or unexpected occurances and proactively participates in resulting investigations
• Organize work schedule and coordinates with cooperating analysis to complete testing on time
• Provides training to new analysis on practiced techniques
• Drafts technical reports demonstrating strong technical writing skills
• Perform specialized maintenance and calibration of laboratory equipment
• Familiar with department and plant systems and effectively operates within systems to achieve desires results
• The Quality Control Chemist 2 performs all of the duties outlined for the Quality Control Chemist 1 as required
• Other duties as assigned by supervisor

Skills:

The Quality Control Chemist 2 minimally possesses basic skills in the performance or operation of the majority of the following. Additionally, the Quality Control Chemist 2 has recognized expertise in 5 or more of the following within 5 years of grade:

• 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 we 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 Manger
• 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 investigation decisions as appropriate
• Provides input into required training decisions and serves as a training resource
• Determines when an analysis is considered trained

Director, Business Development

Norwich Pharmaceuticals, Inc.

Summary of Position:
This person will be responsible for generating Contract Service Revenues and meeting sales quotas by calling on Pharmaceutical Companies interested in contract services offered by Norwich Pharmaceuticals.

Roles and Responsibilities:

In cooperation with the President and other members of the Business Development Group, this person:

Will be responsible for making assessments of marketing opportunities and targeting companies to generate leads for possible sales.

Will be responsible for generating sales management information:

• Reasons for wins and losses
• Progress of opportunities in relation to sales process
• Success rates

Will be responsible to customer relationship management.

Will be responsible for generating sales forecast and probability analysis.

Will be responsible for follow up sales activities.

Will assist in intelligence gathering on customers and competitors.

Will advise and assist on drafting sales policies and procedures.

Will be responsible for making customer sales presentations.

Will participate in the preparation of CDA’s, REP’s, LOU’s and Supply Agreements.

Will participate in trade shows.

Will participate in customer site visits.

Organization Structure:

This position reports to the President of Norwich Pharmaceuticals.

Qualifications / Key Criteria:

• Minimum of 4 year degree with a focus in Science coupled with business experience.
• Minimum of 5 years experience in selling Contract Manufacturing Services/Outsourcing Service or with extensive experience working with a third party Pharmaceutical Contract Manufacturer.
• Experience in selling large-scale commercial manufacturing and clinical services required.
• Experience in selling oral solid and oral liquid dosage manufacturing and development services preferred.
• Experience in selling Clinical Services in combination with manufacturing and development services would be highly attractive.
• Good oral, written, and communication skills.
• Experience in contract negotiations and problem solving.
• Proficient in Microsoft Word, Excel, PowerPoint, and Salesforce.com.

Formulation Scientist - PD&TS

Summary of Position:

The Product Development and Technical Services (PD&TS) Chemist II is a primary resource in performing testing, developing and validating the quality control methodology necessary to support commercialization of pharmaceutical products. The PD&TS Chemist II is responsible for performing the bench chemistry testing of pharmaceutical products supporting product development. Responsibilities include all phases of the project from initial project evaluation through commercialization. The PD&TS Chemist II will assist in installing quality control methodologies and performs development, transfer, validation, and/or qualification for methods related to analyzing raw materials, semi-finished/finished products, and stability and ensures appropriate training and qualification of the receiving quality control laboratory unit. Frequent customer communication and active participation as the analytical chemistry expert on work teams may be required.

Responsibilities:

• Assist in the development of the installation strategy for all quality control methods necessary for commercialization of pharmaceutical products. This includes evaluating validation/qualification/transfer requirements, equipment acquisition/installation, reference standards/reagents, Techs-NM, authoring methods/reports, training, quality standards development, and other steps as required.
• Hands on laboratory bench work for testing supporting development of pharmaceutical products.
• 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 scientific contributions toward troubleshooting, method development and validation difficulties. Works through problems with method installation / acts quickly, efficiently, and relentlessly until root cause is determined and solution is found.
• Contribute to improvements of analytical methods positively affecting accuracy, precision, efficiency, robustness, cost, and reduction of complexity.
• Assist in the development of the method installation strategies designed to simplify use for the QC end user supporting commercial production. Utilizes detailed and concise procedural documentation, automation, new technologies, and computerized solutions to streamline and simplify method execution in the commercial environment.
• 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.
• Identifies work that is out-of-scope with the original project plan and works with customer service and manager to determine cost impact and update the project scope as required.
• Serves as the method expert supporting troubleshooting and problem solving for methods following training and qualification of receiving QC laboratory.
• Manages and maintains project timelines. 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, plus 5-10 years experience in pharmaceutical method development or equivalent combination of experience and education.
• Familiar with GxP (M: manufacturing; L: laboratory) and ICH guidelines.
• Extensive experience with expertise in the majority of the following: HPLC, GC, dissolution, UV-Vis, AA, Karl Fischer, IR, PSD, wet chemistry, and USP/EP compendial test procedures.
• Experience with data acquisition systems such as TotalChrom, ChemStation.
• 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 PD&TS Chemist II has authority to perform all aspects of installation of quality control methodology into NPI. This includes determination of method techniques, choosing appropriate materials, determining test plans, and proposing test / validation criteria.

Lab Assistant

The product Development and Technical Services (PD&TS) Lab Assistant performs activities supporting the laboratory function in executing daily operations of the analytical laboratory duties typically include laboratory custodial maintenance, cleaning of laboratory apparatus and glassware, chemical handling, basic laboratory analysis, preparation of laboratory solutions, administrative function and data manipulation and analysis. The PD&TS Lab Assistant performs work in accordance with established procedures and/or under the supervision of a PD&TS chemist.

Responsibilities:

• Performs laboratory housekeeping duties such as facility cleaning and glassware washing, drying and storage.
• Maintains laboratory apparatus and supplies.
• Performs handling of packaged and open chemicals, removal of expires or depleted stock and coordinates sample disposal.
• Prepares laboratory solutions, mixtures and apparatus used in analysis under the close supervision of a Chemist.
• Performs administrative duties in support of laboratory function such as reagent and sample inventory control ordering, filing, record keeping, distribution, coordination.
• Performs purchase order generation, order for shipment, goods receipts, service entry, init to samp’, or other functions as required in SAP in accordance with training and job aids.
• Maintains laboratory records, files, and Standard Operating Procedures.
• Other duties as assigned by supervisor.
• Work 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.

Qualifications:

• High School Diploma plus 3 years working experience.
• Strong oral and written communications skills.
• Proficient in computer us (Word, Excel, internet) with ability to learn new computer applications.
• Ability to follow standard operating procedures to perform work function.
• Strong clerical aptitude, sound judgment and operates with a sense of urgency in a fast paced environment.
• Strong organizational, communication, and interpersonal skills.

Decision Making:

The PD&TS Lab Assistant has authority to perform work as assigned supporting the laboratory function. This includes following approved procedure and guidance received from supervisors.

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.