Website Mindlance
Mindlance
Company : Mindlance
Job Description (Required): What You Will Achieve:
You will be at the center of our operations, and you ll find that everything we do, every day, is in line with an unwavering commitment to quality. Your work in the Analytical R&D Microbiology Strategy & Testing organization helps enable development of biological therapeutics at Client. Your responsibilities will be applying GMP microbiological methods (bioburden, endotoxin, etc.) in the assessment of product quality and detection of impurities. Your contributions are part of a group performing microbiology identification, testing, and method qualifications to support multiple sites in the Client network. You will be responsible for Environmental Monitoring (EM) of manufacturing facilities, waters, and compressed gases at the site. Responsible for utilizing established microbiological methodologies to support GMP in-process and research & development testing of clinical supplies. You will become proficient in aseptic lab technique and facility gowning to thrive in this fast-paced environment. Your strong foundation in general scientific practice, its principles and concepts will help in meeting critical deadlines. You will be relied on as a technical contributor to assess the assigned tasks and make decisions that involve direct application of your knowledge. It is your focus and commitment that will help in making us ready to achieve new milestones and help patients across the globe.
How You Will Achieve It:
Exercise and build basic team effectiveness skills {e.g., commitment, feedback, consensus management) within the work group.
Review and contribute to technical documents, including validation protocols and reports, analytical test procedures, investigation reports, monitoring trend reports, and change controls.
Directly interact with multiple department team members, including presentation of data.
Complete all Good Laboratory Practice {part of GxP} and safety training in compliance with departmental requirements and follow appropriate safety practices in the workplace.
Perform various experiments for microbial analysis, qualification/validation, and characterization of biological therapeutics.
Perform and document environmental monitoring of manufacturing areas and related Microbiological activities.
Conduct all work according to appropriate Standard Operating Procedures following Good Manufacturing Practices/Good Laboratory Practices (GMP/GLP) requirements and ensure integrity of all data generated and documented.
Independently analyze and provide conclusions regarding data generated.
Plan and prioritize assigned testing activities.
Present problems and propose solutions in discussions with group members.
Education & Experience
Must-Have
Bachelor’s Degree in microbiology, biochemistry, biology, or related field
Good documentation skills with high attention to detail
Strong organizational skills and effective interpersonal and written communication skills
Be self-motivated and highly effective in a team-based environment
Ability to follow established procedures under minimal supervision
Nice-to-Have
Experience with Quality Systems in a Good Manufacturing Practices (GMP) environment
Experience with laboratory data systems such as Laboratory Information Management Systems (LIMS)
Hands on experience or working knowledge in pharmaceutical industry and handling of analytical instruments
Some knowledge of drug development process for progression of biological candidates
Environmental monitoring of ISO 7 and ISO 8 manufacturing areas, reading plates, qualifying media plates, TOC & Conductivity testing, kinetic endotoxin testing, water & pharma gas sampling and testing, and other general support for the laboratory.
Good lab safety awareness and a good foundation in microbiological testing.
Prefer experience of working within a GMP framework with particular regard to manufacturing environments.
Required:
1. Environmental Monitoring Aseptic Techniques
2. Bachelor’s Degree in microbiology, biochemistry, biology, or related field
3. Good lab safety awareness and a good foundation in microbiological testing.
Interview Process:
30-min Panel Interview (Camera On)
Position Comments visible to Supplier:
Request: Clinical-Scientific – Microbiologist
Number of Contractors Needed: 1
Candidate Submission Limit Per Supplier: 2
Shift: Other (08:00 AM – 04:30 PM)
Desired Start Date: 5/6/2025
Hrs/Wk: 40.00
MSP Owner: Franco, Crystal
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans