Jobs

Description

 Top Skills

• Sterility Assurance or sterilization methods/modalities
• Moist heat, dry heat, gamma irradiation, electron beam, ethylene oxide
• Relevant ISO standards
• Autoclave Cycle Development
• Biological indicators knowledge
• Depyrogenation
• Aseptic process simulation or media fills
• Microbiological test methods testing or validation
• United states Pharmacopeia (USP) <51>, <61>, <71>. <85> or Ph Eur or JO equivalent
• Bioburden, total aerobic microbial count (TAMC), Total yeasts and molds count (TYMC), bacterial endotoxins test (BET), Sterility, Antimicrobial Preservative Effectiveness, Pyrogen
• Filter Retention and Microbial Viability
• Experience in Pharma or medical device mfg. environment

Updates

Masters degree will work

Open for non local candidates who are ready to relocate at their own expense

• Provide global microbiology support (support US and out of US MFG sites & Third party manufacturers for products)
• Provide support to Mfg. biologics, parental products, combination medical device products
• Supporting validations for all Microbiology methods for each and every products
• Consult, troubleshooting and providing guidance, write regulatory submissions, write global submissions,
• Whenever there is investigation at mfg. sites team supports microbiology issues and provides guidance how investigations can be conducted or what would be the CAPA for root causes. review those investigation reports as well
• Would write protocols for special tests that are not written but typically the sites will write protocol and reports and this candidate will review them
• Knowledge of ISO standards
• Exp ion Pharma or medical device industry is a plus
• Deal with Bioburden, bacterial endotoxin test
• Will not write publications
• Will write submissions to FDA, EMEA or other countries
• Will present data to senior leadership
• Time management
• Ability to prioritize
• Background in microbiology at a mfg. facility
• Someone who has worked in quality in mfg. site that will be helpful
• Quality exp in mfg. site preferred

Description:
 

Technical expert that will independently investigate, identify, develop, and optimize new methods/ techniques to address critical project needs. Continuously seek to improve existing laboratory methods and processes. Read and adapt literature to accomplish assignments. Demonstrate mastery of broad range of experimental techniques and methods of data analysis.

• Independently design, execute and interpret critical experiments to answer scientific questions. Understand the broad objectives of the project as well as their role in achieving those objectives, and modify experimental plan when required, to respond.
• Learn, understand and master new experimental techniques, and act as a resource or mentor for others.
• Innovate and implement new experimental protocols.
• Demonstrate a high level of proficiency in his/her field.
• Set and meet experimental timelines.
• Effectively organize and present scientific plans and data.
• Contribute to writing and conceptual framework of publications, presentations, and patents.
• Routinely read and apply relevant scientific literature. Impact projects mostly through lab and/or pilot plant-based activities where applicable.

Years of experience/education and/or certifications required:

• BS or equivalent education with typically 7 or more years of experience or MS or equivalent education with typically 5 or more years of experience.

What are the top 3-5 skills requirements should this person have?

• Demonstrated ability to independently design, execute and interpret critical experiments to answer scientific questions.
• Demonstrated scientific writing skills and strong verbal communication skills.
• Ability to multitask and work within timelines.
• Reading and adapting literature
• Reading and applying scientific literature
• Innovate and design a new experimental protocol to solve problems
• Scientific writing skills
• Previous experience in pharmaceutical or medical device fields

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?

• Previous Quality or regulatory experience

What type of environment is this person working in?

• Group environment, working independently on different things

Work Schedule (Define days,# of hours)/ Is Overtime offered or required?

• Monday – Friday 8 – 5; Overtime not required but may be needed occasionally 

Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)?

• Onsite
• Possiblity of working remote up to 2 days a week