Job Details

Requisition Number 20-0112
Post Date 3/20/2020
Title Scientist I
City Woodcliff Lake
State NJ
Description Driven by a commitment to research, quality and service, PDI, Inc. provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world.

We have several locations across the US and are looking for new Associates to join our team!


POSITION PURPOSE

This position is a member of the R&D Analytical team and will work to support development and continued improvement of our Interventional Care drugs and medical devices for projects such as skin antisepsis, device disinfection, and nasal decolonization.

The primary function of this position is to perform GMP and non-GMP analytical testing (assay, ID, impurities, stability), and conduct method developments, validations, and transfers for our Interventional Care business function. This individual will be responsible to uphold our quality, safety, and efficiency in the laboratory.


ESSENTIAL FUNCTIONS AND BASIC DUTIES


RESEARCH & DEVELOPMENT:
a. Performs routine GMP and non-GMP analytical testing using chromatography (GC, LC), titration (auto and manual), and/or spectroscopy (FTIR, NIR, UV/Vis). Tests stability and release samples for pH, color, appearance, and other studies as required.
b. As directed by supervisor, performs testing for method development, validation, and transfers with minimal supervision.

LABORATORY SUPPORT:
a. Prepares mobile phases, buffers, reagents, sample preparations, dilutions, etc. as needed.
b. Maintains supplies and equipment as required.
c. Drafts reports, performs data analysis, and maintains a compliant laboratory notebook.

FORMULATION AND REGULATORY SUPPORT:
a. Adhere to strict timelines and communicate testing status to the larger formulation team.
b. Provide analytical support to QC and regulatory, as needed.


PERFORMANCE MEASUREMENTS
1. Willing to learn additional analytical skills and take on more responsibility and functional activities
2. Able to work efficiently to meet timelines and balance priorities as directed by supervisor.
3. Communicate effectively with other team members and across the organization with R&D, Corporate Quality, and the Quality Control laboratory.
Requirements QUALIFICATIONS

EDUCATION/CERTIFICATION:
• University degree in Science or Engineering required
• Degree(s) in Chemistry preferred

REQUIRED KNOWLEDGE:
• Previous experience in a R&D or QC lab working with chromatography equipment
• Analytical chemistry, method development and validation understanding.
• Willing to learn the FDA, ICH, etc. regulations directing their testing

EXPERIENCE REQUIRED:
• 1-3 yrs in a R&D or QC laboratory
• Previous experience working in a GMP laboratory highly desired
• Chromatography experience (LC preferred), and demonstrated proficiency with a variety of other analytical instrumentation

SKILLS/ABILITIES:
• GMP experience; able to follow explicit directions, keep diligent records, and conduct work with the highest integrity.
• Excellent communication skills (verbal / written).
• Computer literate (MS 365, Empower, Electronic Notebook).


WORKING CONDITIONS

About 80% Lab and 10% office environment. Willing to routinely travel between headquarters and production facilities (30 min)

#LI-PDI
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INTENT AND FUNCTION OF JOB DESCRIPTIONS

Job descriptions assist organizations in ensuring that the hiring process is fairly administered and that qualified employees are selected. They are also essential to an effective appraisal system and related promotion, transfer, layoff, and termination decisions. Well-constructed job descriptions are an integral part of any effective compensation system.

All descriptions have been reviewed to ensure that only essential functions and basic duties have been included. Peripheral tasks, only incidentally related to each position, have been excluded. Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions. In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all-inclusive. Additional functions and requirements may be assigned by supervisors as deemed appropriate.

In accordance with the Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals. However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose undue hardships on the organization.

Job descriptions are not intended as and do not create employment contracts. The organization maintains its status as an at-will employer. Employees can be terminated for any reason not prohibited by law.
  • Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
  • Please view Equal Employment Opportunity Posters provided by OFCCP here.
  • The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
  • Please refer to the Company’s Substance Abuse Policy which protects the safety and well-being of all associates and potential associates.
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