Sr. Clinical Microbiologist
This position is a member of the R&D Microbiology team to conduct antimicrobial testing, method development and scientific research in support of PDI’s growth strategies.
The position is a key component of scientific advancement in skin antisepsis and medical device disinfection. Primarily, the role supports new market launches with input across all facets of project progression including scientific insights, prototype assessment and clinical testing to meet regulatory requirements. In addition, developing equity building studies that enhance PDI’s current portfolio to provide a competitive edge in a challenging marketplace.
Be an agent of change by creating new methods and cultivating complex scientific research into understandable language for the non-technical.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
RESEARCH & DEVELOPMENT:
a. Perform antimicrobial testing studies according to FDA requirements.
b. Manage external in-vitro and in-vivo GxP studies.
c. Actively seek new partnerships in both technologies and testing support.
d. Partner with the Healthcare Industry and/or Academia to propose new scientific and behavioral research.
e. Develop novel methodologies in support of new product territories/claims.
f. Leads own projects and scientific endeavors.
g. Maintain a pulse on Industry direction with respect to new claims.
h. Represent PDI in industry groups and technical committee meetings.
i. Prepare technical reports, scientific publications and technical presentations for internal meetings.
a. Responsible for the creation and maintenance of quality management systems.
b. Provide technical training to your peers and foster a laboratory environment of collaboration.
c. Optimize laboratory space to ensure an efficient flow of work.
d. Prepare media and process glassware as necessary to perform experiments.
e. Create new SOPs where gaps exist. Maintain SOP version revisions for continuous improvement initiatives.
FORMULATION AND REGULATORY SUPPORT:
a. Help formulators to determine the correct test method for product tests and partner to develop effective chemistries.
b. Identifies technical and project risks and proactively recommends strategies and options to management to avoid/mitigate risks.
c. Provide input to regulatory strategies as it relates to Microbiology Test methods.
1. Demonstrate research skills to create new test methods/territories in support of PDI’s growth targets.
2. Ability to work in partnership with the product development and regulatory functions without supervision.
3. Support work stream timelines and be able to balance priorities according to stakeholder needs.
4. Able to communicate and cooperate with other team members and cross function teams effectively.
5. Demonstrate ability to add value to the organization through scientific excellence and creative thinking.
6. Take ownership for assigned projects and self-lead initiatives.
EDUCATION/CERTIFICATION: • University Degree in a Biological Science required
• Masters/Ph.D. an advantage
REQUIRED KNOWLEDGE: • Rich Microbiology understanding.
• Working knowledge of FDA regulations including filing requirements.
• Demonstrate understanding of Good Clinical Practices.
• Understands R&D processes for development and launch of new products.
• Strategic thinking in a competitive landscape.
EXPERIENCE REQUIRED: • 5+ years of R&D working experience (academic or industry)
• Ability to develop new test methods.
• Desire to succeed and grow career in a fast moving and dynamic R&D environment.
• Clinical Microbiology experience.
• Previous experience of wipes advantageous
• Previous experience within the Healthcare industry advantageous
SKILLS/ABILITIES: • Excellent communication skills (verbal / written). Ability to explain science to management.
• Prudent risk taker. Identifies opportunities and takes risks to achieve objectives.
• Able to work on multiple projects of varying complexity.
• Able to influence cross-functional partners to gain support and alignment to ideas.
• Computer literate (Outlook / Word / Excel).
NONE: About 50% Lab and 50% office environment
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.
Nice-Pak Products, Inc. (NP) is the global developer, manufacturer and marketer of pre-moistened wipes for the consumer market, specializing in personal care, hygiene, household cleaning and disinfection products.