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POSITION TITLE: Lab / Sterile Production Technician
SPECIFICATION NUMBER: 69907CRI
LOCATION: Wharton, New Jersey
COMPENSATION: $Hourly – 40 hours a week and time and half OT over 40 hours – 4 day work week
DURATION: 6 months and possibly be extended or cross over to permanent.
COMPANY: Our client is a Compound Medication producer.
POSITION SUMMARY
Technician will be responsible for conducting cGMP manufacturing of sterile pharmaceutical dosage forms for commercial manufacturing. Under the direction of the Production Supervisor, the Sterile Production Technician will work hands on, under ISO7 and ISO5 area, with a variety of manufacturing production equipment and technologies. Daily responsibilities vary and include production equipment set up, weighing of materials, manufacturing of batches, sterilization of product, submitting samples, performing filling operations under ISO5 environment.
This is an opportunity to play a key-role in an aggressive, growth-oriented Company that provides an entrepreneurial work environment in an emerging industry.
ESSENTIAL DUTIES AND RESPONSIBITIES
Ensures that all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs). Knowledge of current Good Manufacturing Practices (GXP) guidelines.
Gowning up to 10 hours per day- 4 days per week. Gowning/Aseptic Technique Experience
Reports any accidents, incidents and injuries or illnesses immediately and notifies manager of any hazards, unsafe acts or conditions in the workplace
Prepares for production run by reviewing the production schedule; identifying batch specific requirements; weighing and measuring ingredients and adding to mixing equipment.
Operation of pharmaceutical manufacturing equipment including automated aseptic fill lines, washers, ovens, filter integrity testers and autoclaves with mechanical aptitude.
Completes all necessary cleaning and sanitizing of production equipment and area. Accurate completion of production documentation and all appropriate logbooks. Maintains cleaning logs per SOP requirements.
Updates job knowledge by participating in training opportunities. Takes ownership for individual training plan.
Assists with the training of new operators as required and support investigating non-conformance deviations.
Cross train and provide support in other areas such as manual vial inspection, labelling and packaging and Other duties and responsibilities as assigned,
Excellent organization and time-management skills required. Must be able to manage heavy workload and aggressive timelines in a timely manner, prioritize and work under pressure.
Must possess technical knowledge to operate and troubleshoot all operating equipment with minimal help.
Responsible to review all documentation including Batch records and Logbooks in “Real Time and Right First Time” and demonstrate error free documentations. Immediately reports any error or deviations noticed to management.
QUALIFICATIONS
High School diploma with 5 years -Pharma/Biotech Manufacturing Support and 3 years- within Clean Room environments and some technical certification is desired in related field.
Demonstrated ability to successfully gown into aseptic manufacturing areas.
Environmental Monitoring, Water and product sampling.
Fluent in English both written and spoken.
Strong work ethic, Positive Attitude, Time Management, Problem Solving, Team Player, Self-Confidence & Ability to Accept & apply Lessons Learned as needed. Works with a sense of urgency, while engaging and listening to experts.
Ability to work in a fast-paced environment while demonstrating excellent time management and organization skills.
Strong organizational skills with the proven ability to prioritize.
Proficient in the use of standard Microsoft Office software products, including Excel, Outlook, Word
Ability to handle sensitive information with a high degree of confidentiality.
Must be flexible to work 1st or 2nd shift with holidays, weekends and overtime as per business needs. Work hours will be subject to change as required based on business demand and production workload.
COMPETENCIES
Customer/Client Focus.
Ethical Conduct respect for others and solidarity.
Technical Capacity to operate and troubleshoot processing equipment.
Conscientiousness for work and documentation.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions.
While performing the duties of this job, the employee is regularly required to communicate effectively. The ability to see distinctions in colors and shapes is also required. This position is moderately active and requires standing and walking for the duration of the shift. There is a high frequency of reaching over your head and bending down throughout the duration of each shift.
WORK ENVIRONMENT
While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.
This job operates in a health care setting. This position requires frequent standing and walking to storage shelves and filling counters to fill prescriptions. While performing the duties of this role, the employee will be exposed to light, noise and ability to lift to 50lbs.
POSITION TYPE AND EXPECTED HOURS OF WORK
This is a full-time position that will start out on first shift and then move to a 1st or 2nd shift position (Monday to Thursday). This position may occasionally flex between shifts and variable hours depending on business needs.
Our client has immediate opportunities for 1st and 2nd shifts - 5am and 7am - 4/10 hours days.
Sometime in March they will be changing to traditional 1st shift 7am and 3pm - 5/8 hours days. Shift differential will be offered for 2nd shift.
Please note that these shifts are subject to change based upon production schedules.
POSITION TITLE: Lab / Quality Technician (Position Filled)
SPECIFICATION NUMBER: 68898CRI
LOCATION: Morristown, New Jersey
COMPENSATION: $Hourly – 40 hours a week and time and half OT over 40 hours
DURATION: Now to the end of the year and possible be extended or cross over to permanent.
COMPANY: Our client is a leader in the Medical Device industry.
POSITION SUMMARY
Responsible for the daily QC Lab functions, including testing of product, calibration of lab equipment, testing for raw materials and paperwork and process audits.
This is an opportunity to play a key-role in an aggressive, growth-oriented Company that provides an entrepreneurial work environment in an emerging industry.
ESSENTIAL DUTIES AND RESPONSIBITIES
Accurately perform and report daily testing of product according to established methods and requirements.
Manage the testing schedule to support timely deliveries of customer orders.
Evaluation of test data to support production.
Interface with production personnel to communicate status of testing.
Monitor and report test status of various production runs to QC Manager, Manager of Ink Technology, or Process Engineer.
Provide support to R & D as needed.
Maintain necessary calibrations for lab instruments and equipment, i.e. densitometers, thermocouples, thermometers.
Assist in the inspection and testing of raw materials used in the manufacturing process.
Perform trend analysis of data and make recommendations for improvements.
Support data collection activities by entering information into various databases and spreadsheets.
QUALIFICATIONS / COMPETENCIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
The requirements listed below are representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Training may be necessary to improve, assess and verify improvement of employee competencies through the Performance and Development Appraisal process (PDA).
EDUCATION
Must have a High School Diploma or GED and two to four years related experience and/or training or a combination of equivalent education and experience.
GENERAL QUALIFICATIONS / ENVIRONMENT
Language Ability:
Good verbal and written communication skills necessary. Must be able to read and follow written instructions and generate legible records of work performed.
Math Ability:
Must have a basic knowledge of elementary statistics. It is desirable for an individual to have an understanding of statistical sampling and process capability.
Reasoning Ability:
Ability to create, read and interpret graphical data as it relates to test results.
Computer Skills:
Basic computer skills: Word processing, knowledge of spreadsheet functions, and electronic mail in a Windows environment.
Certificates and Licenses:
No certification necessary. Experience in an ISO or GMP environment is highly desirable.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job the employee is occasionally exposed to moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals and extreme cold. The noise level in the environment is quiet.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee is regularly required to lift up to 10 pounds. The vision requirements include close vision and distance vision.
INTERPERSONAL / OTHER SKILLS:
Key Critical Skills:
Able to use judgment to make decisions relating to product quality
Able to review data to identify trends; based on those trends identify and implement corrective action before trend results in out-of-specification condition
Ability to apply common sense understanding to develop and carry out instructions furnished in writing, oral or diagram form. Ability to define problems, and draw valid conclusions
Excellent mathematical skills
Well organized and able to prioritize and manage multiple activities/projects simultaneously
Strong communication skills to effectively interact with Manufacturing/Quality personnel, vendors, customers and management; verbally and in writing
Other Desired Skills:
Strong business acumen
Results oriented
Creative
Enthusiastic
Sense of urgency
Intellectually curious
Persistent
Leadership qualities, effective communicator both externally and internally
Flexibility
Team Player
Able to develop people
Hands-on
Self-starter
Ability to multi-task
Sense of urgency
Well organized
Cooperative; able to resolve conflict
Goal oriented
Strong work ethic
Pre-disposition to identify opportunities for improvement as well as recommend and implement solutions
POSITION TITLE: Regulatory Affairs Manager (Position Filled)
SPECIFICATION NUMBER: 66323CRI
LOCATION: Princeton, New Jersey
COMPENSATION: $200,000 + Bonus
COMPANY:
Our client is a leader in the Pharmaceutical Industry
POSITION SUMMARY
You will serve as the US Regulatory Lead for a portfolio of assigned projects. Manage projects through all phases of development, post-approval and life-cycle management. Work with the global Bio-pharm Regulatory Affairs (BRA) Leads to develop regulatory strategies, provide regulatory guidance, critically review documents for submission to FDA, and oversee the execution of the US regulatory strategy in line with the project team’s goals. Represent US BRA on cross-functional project teams, clinical and commercial teams, and provide strategic regulatory leadership. Supervise and mentor other regulatory staff working on assigned products and regulatory process-related topics.
MAJOR ACCOUNTABILIIES:
• Ensures the overall regulatory strategy aligns with the target product profile (TPP), US specific needs, US bio-similar regulatory environment, and global development strategy for assigned projects.
• Represents US BRA as a member of the cross functional project team to provide regulatory guidance throughout the research, development, launch and post-approval process. Acts as the single point of contact for the business on US regulatory issues for assigned projects. Interacts with key scientific, clinical research, and commercial personnel within and outside the company to ensure timely and accurate regulatory compliance.
• Identifies and assesses regulatory risks associated with product development. Defines strategies to mitigate risks.
• Acts as a FDA liaison contact for project issues. Leads FDA project meetings and major label negotiations with FDA.
• Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects and programs, including IND, BLA, NDA, 510(k), product line extension application, change control supplements and labeling supplements.
• Reviews reports from contributing functions and provides comments to assure accurate and complete documents for FDA submissions.
• Coordinates and supervises the development of regulatory strategies for new medical devices as part of combinational product registration for injectable biologics.
• Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to bio-similar products and understand the impact on current and future submissions.
• Leads work plans and provides regulatory affairs direction to lower-level resources. Creates schedules and work plans for monitoring, compiling and submitting filings that are consistent with company standards. Often plays a proactive role in developing and applying new approaches to tracking data and submitting filings.
• Participates in the modification, development and implementation of company policies and practices for regulatory affairs that affect subordinate resources.
• Directs the activities of resources, both internal and outside contractors/vendors, with similar technical or functional responsibilities. Responsible for implementing operation- al and strategic policies and directives. Develops functional processes for area man- aged.
• Interfaces with senior management to report on project and program milestones andto present project needs. Requires the ability to influence others to achieve results. Assignments are given in the form of objectives with no process defined. May or may not manage lower-level supervisors.
SUPERVISORY
• May manage lower level employees; Supervises junior regulatory staff with the planning, preparation and submission of regulatory documentation.
KEY PERFORMANCES
• Ability to translate over-arching goals into specific objectives and strategies to meet these objectives.
• Demonstrates a track record of successful interaction with FDA, as manifested by successful and timely submissions and approvals of bio-similar products.
• Build and maintain excellent relationships with FDA. Utilizes familiarity with the intricacies and nuances of different review divisions within FDA, as well as the decision- makers within the agencies.
• Successful interactions with R&D and commercial leadership teams. Diverse and sufficient technical expertise to be a credible interface to all development and business partners (CMC, preclinical, clinical, statistician, sales and marketing, legal, etc.). Able to lead and influence cross functional teams, committees to attain group goals.
• Demonstrates in-depth working knowledge in interpreting regulations, guidelines, guidance, policy statements. Applies regulatory and therapeutic area knowledge to commercial team’s objectives and initiatives for developing vision and solutions for effective communication.
• Assignments are received in task and objective oriented terms. Provides direction to subordinates based on general policies and management guidance. Work is reviewed upon completion for adequacy in meeting objectives.
• Interprets and executes policies and procedures that typically affect subordinate organizational units. Recommends modifications to operating policies.
• Functions as an advisor to a unit regarding tasks, projects, and operations. Becomes actively involved in daily operations only when required to meet schedules or to resolve complex problems.
• Ensures that projects are completed on schedule and within budget. Erroneous decisions or recommendations or failure to complete assignments would normally result in serious delays to assigned projects resulting in considerable expenditure or additional time, human resources, and funds.
• Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling of specific phases of projects or contracts. Conducts briefings and participates in technical meetings for internal and external representatives concerning specific operations.
EDUCATION
Bachelor's Degree required
PhD, PharmD or MS in Biology or Chemistry preferred
EXPERIENCE
10+ years of professional related experience including a minimum of 7 years of regulatory experience preferred. Experience in CMC regulatory and biologics preferred.
KEYWORDS
Biosimilars, biologics, NDA, BLA, submission, large molecule, FDA primary contact, FDA liaison
POSITION TITLE: Research & Development - Atomic Spectroscopy Senior Research Leader
SPECIFICATION NUMBER: 66315CRI
LOCATION: New Haven, Connecticut (area)
COMPENSATION: Base salary: $175,000 range (based on market rate & experience)
COMPANY:
Our client is a leader in life science and environmental applications.
POSITION SUMMARY
The senior atomic spectroscopy research leader is responsible for driving innovation & disruptive technologies for products with ~$200 million/year in revenue. This position requires thought leadership, industry expertise, customer relationships, leveraging collaboration ecosystems and driving specific research projects aligned with the product line strategies
KEY RESPONSIBILITIES
Identify long term customer needs, monitor technology trends & market shifts and drive research projects to deliver differentiated market products and services
Complete competitive assessments and product tear-downs to identify gaps and opportunities.
Mange Intellectual Property for spectroscopy product lines, including patent renewals and new patent filings.
Collaborate with other key areas (including product development, product management, service or marketing) and identify product need and then translate those needs to plans and actions.
Identify & engage leading external research groups for non-core and/or emerging technology areas.
Identify, develop and manage university collaborations in relevant areas; prepare collaborative research proposals for review by leadership.
Maintain a day to day research program in the lab environment, including resources, expenses and capital improvements.
Provide technical oversight and guide group member activities.
Proactively collaborate cross-functionally to product and business plans to drive profitable growth.
Prepare research project plans; execute those plans and/or assist others in doing so.; communicate results and business significance to senior leadership accordingly.
Work to evaluate critical projects with emphasis on speed of learning & decisions; projects should be continued, shifted or stopped as progress and learnings warrant.
Staff of 2: Application Scientist and Optical Design Engineer.
JOB REQUIREMENTS
MS degree in Chemistry with emphasis in Spectroscopy. PhD is preferred
8+ years of experience in Atomic Spectroscopy.
Technical Skills: Strong understanding of analytical and physical sciences and instrumentation with emphasis on Atomic Spectroscopy (especially AA and ICP-OES).
Knowledge of the systems and processes required for analytical measurements, the concept of uncertainty and factors affecting signal to noise.
Ability to identify high-risk, high reward concepts of interest. Identify innovative opportunities in adjacent technologies.
Communication Skills: Demonstrates interpersonal skills required to interface with cross functional teams to ensure completion of initiatives.
Management of Resources: Allocates time and resources efficiently, focusing on ever-shifting priorities; continually seeks way to improve individual/team efficiency.
Ability to manage and lead other science professionals; identify potential candidates for open positions, justify needed positions and candidate qualifications.
Business & Organization Knowledge: Understands our client’s business and the impact of the R&D organization on the operation.
Participate in professional societies and standards bodies (e.g. ASTM), present research papers where appropriate.
Change Management: Exhibits an assertive personality with a strong bias for action with a results-orientation; tackles tough problems with firm deadlines.
EDUCATION
Master's Degree
TRAVEL
10%
POSITION TITLE: Quality Technician (Lab Technician)
SPECIFICATION NUMBER: 68872CRI
LOCATION: Morristown, New Jersey
COMPENSATION: $Hourly Consultant: 6-9 month contract (then can possibly cross over to Permanent)
COMPANY: Our client is a leader in the Medical Device industry.
POSITION SUMMARY
Responsible for the daily QC Lab functions, including testing of product, calibration of lab equipment, testing for raw materials and paperwork and process audits.
This is an opportunity to play a key-role in an aggressive, growth-oriented Company that provides an entrepreneurial work environment in an emerging industry.
ESSENTIAL DUTIES AND RESPONSIBITIES
Accurately perform and report daily testing of product according to established methods and requirements.
Manage the testing schedule to support timely deliveries of customer orders.
Evaluation of test data to support production.
Interface with production personnel to communicate status of testing.
Monitor and report test status of various production runs to QC Manager, Manager of Ink Technology, or Process Engineer.
Provide support to R & D as needed.
Maintain necessary calibrations for lab instruments and equipment, i.e. densitometers, thermocouples, thermometers.
Assist in the inspection and testing of raw materials used in the manufacturing process. Perform trend analysis of data and make recommendations for improvements.
Support data collection activities by entering information into various databases and spreadsheets.
QUALIFICATIONS / COMPETENCIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
The requirements listed below are representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Training may be necessary to improve, assess and verify improvement of employee competencies through the Performance and Development Appraisal process (PDA).
EDUCATION
Must have a High School Diploma or GED and two to four years related experience and/or training or a combination of equivalent education and experience.
GENERAL QUALIFICATIONS / ENVIRONMENT
Language Ability:
Good verbal and written communication skills necessary. Must be able to read and follow written instructions and generate legible records of work performed.
Math Ability:
Must have a basic knowledge of elementary statistics. It is desirable for an individual to have an understanding of statistical sampling and process capability.
Reasoning Ability:
Ability to create, read and interpret graphical data as it relates to test results.
Computer Skills:
Basic computer skills: Word processing, knowledge of spreadsheet functions, and electronic mail in a Windows environment.
Certificates and Licenses:
No certification necessary. Experience in an ISO or GMP environment is highly desirable.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job the employee is occasionally exposed to moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals and extreme cold. The noise level in the environment is quiet.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee is regularly required to lift up to 10 pounds. The vision requirements include close vision and distance vision.
INTERPERSONAL / OTHER SKILLS:
Key Critical Skills:
Able to use judgment to make decisions relating to product quality
Able to review data to identify trends; based on those trends identify and implement corrective action before trend results in out-of-specification condition
Ability to apply common sense understanding to develop and carry out instructions furnished in writing, oral or diagram form. Ability to define problems, and draw valid conclusions
Excellent mathematical skills
Well organized and able to prioritize and manage multiple activities/projects simultaneously
Strong communication skills to effectively interact with Manufacturing/Quality personnel, vendors, customers and management; verbally and in writing
Other Desired Skills:
Strong business acumen
Results oriented
Creative
Enthusiastic
Sense of urgency
Intellectually curious
Persistent
Leadership qualities, effective communicator both externally and internally
Flexibility
Team Player
Able to develop people
Hands-on
Self-starter
Ability to multi-task
Sense of urgency
Well organized
Cooperative; able to resolve conflict
Goal oriented
Strong work ethic
Pre-disposition to identify opportunities for improvement as well as recommend and implement solutions
POSITION TITLE: Scientist
SPECIFICATION NUMBER: 68934CRI
LOCATION: Morristown, New Jersey
COMPENSATION: $80,000 - $90,000+ 12% Bonus
COMPANY: Our client is a leader in the Medical Device industry.
POSITION SUMMARY
Plans and conducts lab experiments, interprets data and reports results to support research and development projects.
REQUIRED SKILLS AND EXPERIENCE
Product Development, with a focus on early-stage development of chemistry and technology to explore its potential for commercialization
Strong hands on R&D laboratory skills.
Must have personally taken chemistry-related projects from concept, prototype through development, qualification to commercialization.
Proficient using Analytical Instrumentation and interpreting results provided in order to advance innovative projects (Examples include; FTIR, DSC, UV/Vis spectrometer, Microscope, Particle Size Analyzer, etc.)
Strong hands-on lab skills and ability to draw conclusions from results
Strong documentation skills (Protocol reports, R&D reports, work instructions, SOPs, verbal presentations to management, etc.)
Project Management and Time Management skill sets
NICE TO HAVE
Experience with any of the following disciplines emulsion science, polymer science, organic chemistry, reaction kinetics, formulation of inks or other surface coatings, web-based processes such as printing or adhesives lamination
Experience working in a regulated environment (ISO, cGMP)
DUTIES AND RESPONSIBILITIES
Plans and conducts research activities effectively following the product development process (PDP) using laboratory equipment and chemicals, with appropriate use of computer software.
In addition to carrying out routine tasks with minimal supervision, can exercise creativity and work independently. (Supervision is at the assignment and project level, rather than at the task level.)
Understands the role of ingredients in product formulations and is able to modify formulae to investigate changes to product performance.
Knows how to perform a wide range of analytical tests, with an understanding of their scientific basis and is therefore able to modify test methods to investigate other aspects of sample behavior.
Interprets data to assess trends and interactions, summarizing results and recommending further investigation.
Responds to changing priorities to complete experiments within deadlines.
Develops and performs tests to support customers under guidance and with review by Sales & Marketing.
Writes memos, work instructions, and protocols for further review.
Represents R&D on teams with representatives of other functions such as QC and Operations.
Creates effective relationships with internal customers and possibly external customers on occasion.
Follows work instructions with rigor and raises questions when unexpected results are obtained.
Maintains a detailed lab notebook with complete descriptions of experimental procedures, results, and conclusions. Ensures notebook is witnessed in a timely manner.
Follows safe work practices; must assess and take into account any hazards associated with the equipment and chemicals (referring to MSDS).
QUALIFICATIONS / COMPETENCIES
Education and Experience: Bachelor’s Degree in science/technology (Chemistry preferred) (Associate’s Degree may be suitable, with relevant experience) preferably with laboratory work experience in the chemical or pharmaceutical industries.
If candidate has a BS, must have about 10 years industrial experience in innovation and new technologies.
If candidate has a MS (and we prefer MS with thesis), must have about 5 years’ industrial experience in innovation and new technologies.
If candidate has a Ph.D., must have industrial experience of at least 2 years’ industrial experience in innovation and new technologies, preferably more, and the individual must be very practical, not academic.
Language Ability: Excellent verbal and written communication skills are necessary. No foreign-language skills are needed.
Math Ability: Must have a basic knowledge of statistics. Six Sigma certification is not required but is beneficial, as is training and experience using a range of statistical tools.
Reasoning Ability: Ability to create, read and interpret graphical data Additional training in problem-solving techniques and teamwork may be provided.
Computer Skills: Basic computer skills are essential: Word processing, knowledge of spreadsheet calculations and graphing, electronic document sharing and storage, and electronic mail in a Windows environment. Training may be required in the use of specific computer software.
Certificates and Licenses: No certifications are needed but computer, electrical, engineering, first aid or health/safety-related certificates are beneficial. Experience in an ISO or GMP environment is highly desirable.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee works primarily in the laboratory but moves between the office, laboratory, instrument rooms, and manufacturing areas. In the laboratory and instrument rooms the employee engages in hands-on operation of lab equipment, uses various measurement devices, and operates small-scale “pilot” model equipment. Hazardous and non-hazardous chemicals are used in small amounts with protective equipment. While performing the duties of this job the employee is occasionally exposed to extreme cold, for which warm clothing is provided. In the manufacturing environment the employee is an observer only.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee must be capable of operating of lab equipment, transporting samples and equipment throughout the site (including up and down stairs), and using protective equipment and safety devices. While performing the duties of this job the employee is regularly required to use hands to finger, handle, feel, write, type, reach with hands and anns; and talk or hear. Employee is frequently required to stand, stoop, sit, kneel, crouch, crawl and bend. The vision requirements include close vision, distance vision, peripheral vision, and depth perception. The employee is frequently required to sit or stand for extended periods. The employee is occasionally required to stoop, kneel, crouch, or crawl. The employee is regularly required to lift up to I 0 pounds.
INTERPERSONAL / OTHER SKILLS:
Strong leadership skills
Flexibility
Results oriented
Team Player
Creative
Hands On
Enthusiastic
Self Starter
Persistent
Ability to multi-task
PERSONAL ATTRIBUTES
Results-oriented, a self-starter, and a team player who will form strong, supportive collaborations FSD
High energy, goal oriented with strong work ethic.
Hands on, team player that will do what it takes to make the entire Company team successful.
Self-motivated with a pre-disposition to identify opportunities for improvement as well as recommend and implement solutions.
Intellectually curious
Thorough and organized with a keen sense of urgency.
POSITION TITLE: Project Scientist
SPECIFICATION NUMBER: 68939CRI
LOCATION: Morristown, New Jersey
COMPENSATION: $80,000 - $90,000+ 14% Bonus
COMPANY: Our client is a leader in the Medical Device industry.
POSITION SUMMARY
Plans and oversees R&D projects. Conducts lab experiments, interprets data and reports results in the execution of research and development projects.
REQUIRED SKILLS AND EXPERIENCE
Product Development, with a focus on early-stage development of chemistry and technology to explore its potential for commercialization
Strong hands on R&D laboratory skills.
Must have personally taken chemistry-related projects from concept, prototype through development, qualification to commercialization.
Proficient using Analytical Instrumentation and interpreting results provided in order to advance innovative projects (Examples include; FTIR, DSC, UV/Vis spectrometer, Microscope, Particle Size Analyzer, etc.)
Strong hands-on lab skills and ability to draw conclusions from results
Strong documentation skills (Protocol reports, R&D reports, work instructions, SOPs, verbal presentations to management, etc.)
Project Management and Time Management skill sets
NICE TO HAVE
Experience with any of the following disciplines emulsion science, polymer science, organic chemistry, reaction kinetics, formulation of inks or other surface coatings, web-based processes such as printing or adhesives lamination
Experience working in a regulated environment (ISO, cGMP)
DUTIES AND RESPONSIBILITIES
Plans, organizes and conducts research often within a cross-functional project team using laboratory equipment and chemicals, with appropriate use of computer software.
Has a solid understanding of the Product Development Process and ensures the timely completion and documentation of the required steps within the process.
Provides technical guidance within and outside the R&D department for solving unusual problems or designing experiments to understand complex variable interactions.
In the evaluation of new raw materials and vendors, conducts audits of vendor quality systems where technical expertise is required to ensure that raw materials meet identified requirements, and identifies/implements effective specifications to ensure quality.
Ensures all appropriate documentation is established for R&D equipment validations.
Possesses a general awareness/understanding of the technical aspects involved in the various Manufacturing processes in order to contribute to high-level discussions about operational issues.
In addition to carrying out routine tasks with minimal supervision, can exercise creativity and work independently. (Supervision is at the assignment and project level, rather than at the task level.)
Understands the role of ingredients in product fonnulations and is able to modify formulae to investigate changes to product performance.
Knows how to perform a wide range of analytical tests, with an understanding of their scientific basis and is therefore able to modify test methods to investigate other aspects of sample behavior.
Interprets data to assess trends and interactions, summarizing results and recommending further investigation.
Responds to changing priorities to complete experiments within deadlines.
Develops and performs tests to support customers under guidance and with review by Sales & Marketing.
Writes memos, work instructions, and protocols for further review.
Represents R&D on teams with representatives of other functions such as QC and Operations.
Creates effective relationships with both external and internal customers.
Follows work instructions with rigor and raises questions when unexpected results are obtained.
Maintains a detailed lab notebook with complete descriptions of experimental procedures, results, and conclusions. Ensures notebook is witnessed in a timely manner.
Follows safe work practices; must assess and take into account any hazards associated with the equipment and chemicals (refe1Ting to MSDS).
QUALIFICATIONS / COMPETENCIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Training may be necessary to improve, assess and verify improvement of employee competencies through the Personal Performance Review (PPR).
Education and Experience: Bachelor's Degree in science/technology with at least 5 years of experience in research and development within the chemical or pharmaceutical industries. Experience in the areas of new product development, process development and technology transfer is preferred.
If candidate has a BS, must have about 10 years industrial experience in innovation and new technologies.
If candidate has a MS (and we prefer MS with thesis), must have about 5 years’ industrial experience in innovation and new technologies.
If candidate has a Ph.D., must have industrial experience of at least 2 years’ industrial experience in innovation and new technologies, preferably more, and the individual must be very practical, not academic.
Language Ability: Excellent verbal and written communication skills are necessary. No foreign-language skills are needed.
Math Ability: Must have a basic knowledge of statistics. Six Sigma certification is not required but is beneficial, as is training and experience using a range of statistical tools.
Reasoning Ability: Ability to create, read and interpret graphical data Additional training in problem-solving techniques and teamwork may be provided.
Computer Skills: Basic computer skills are essential: Word processing, knowledge of spreadsheet calculations and graphing, electronic document sharing and storage, and electronic mail in a Windows environment. Training may be required in the use of specific computer software.
Certificates and Licenses: No certifications are needed but computer, electrical, engineering, first aid or health/safety-related certificates are beneficial. Experience in an ISO or GMP environment is highly desirable. Training in statistical analysis of laboratory data is desired.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee works primarily in the laboratory but moves between the office, laboratory, instrument rooms, and manufacturing areas. In the laboratory and instrument rooms the employee engages in hands-on operation of lab equipment, uses various measurement devices, and operates small-scale “pilot” model equipment. Hazardous and non-hazardous chemicals are used in small amounts with protective equipment. While performing the duties of this job the employee is occasionally exposed to extreme cold, for which warm clothing is provided. In the manufacturing environment the employee is an observer only.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee must be capable of operating of lab equipment, transporting samples and equipment throughout the site (including up and down stairs), and using protective equipment and safety devices. While performing the duties of this job the employee is regularly required to use hands to finger, handle, feel, write, type, reach with hands and anns; and talk or hear. Employee is frequently required to stand, stoop, sit, kneel, crouch, crawl and bend. The vision requirements include close vision, distance vision, peripheral vision, and depth perception. The employee is frequently required to sit or stand for extended periods. The employee is occasionally required to stoop, kneel, crouch, or crawl. The employee is regularly required to lift up to I 0 pounds.
INTERPERSONAL / OTHER SKILLS:
Strong leadership skills
FlexibilityResults oriented
Team Player
Creative
Hands on
Enthusiastic
Self Starter
Persistent
Ability to multi-task
PERSONAL ATTRIBUTES
Results-oriented, a self-starter, and a team player who will form strong, supportive collaborations FSD
High energy, goal oriented with strong work ethic.
Hands on, team player that will do what it takes to make the entire Company team successful.
Self-motivated with a pre-disposition to identify opportunities for improvement as well as recommend and implement solutions.
Intellectually curious
Thorough and organized with a keen sense of urgency.