Scientist Genomic Medicine Bioanalytics Qc Jobs in Maine

Oversee and guide lab analysts on continuous improvement tools such as standard work and visual management.

Oversee project management of all Data Integrity related activities with the relevant teams.

Manage multiple projects and ongoing work activities of moderate complexity within the division typically involving cross-functional representatives.

Demonstrated experience in Quality Control

Reasoning ability including strong analytical and problem solving abilities

Strong verbal and written communication skills

Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development

Broad Knowledge and Hands-on experience in HPLC, compendial analytical and microbiological methods, capillary gel electrophoresis, ELISA and plate-based assays.

Experience in method verification, qualification, validation and transfer.

Excellent effective written and verbal communication and interpersonal skills; established relationships within business lines

Applies discipline’s principles, appropriate procedures, and leadership skills to action plan and contribute to executing toward team/project goals

Demonstrated experience in Quality Control

Responsible for detailing requirements for Laboratory Information Management System builds, building, testing and managing its Master Data changes.

Experience within the biopharmaceutical industry, including knowledge and experience relevant to biopharmaceutical unity operations and/or laboratory operations.

Able to create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records.

Demonstrated experience in manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.

Excellent effective written and verbal communication and interpersonal skills

Laboratory experience, including Cell Culture, Bioassay, Aseptic Technique, and ELISA

Oversee and guide lab analysts on continuous improvement tools such as standard work and visual management.

Oversee project management of all Data Integrity related activities with the relevant teams.

Manage multiple projects and ongoing work activities of moderate complexity within the division typically involving cross-functional representatives.

Reasoning ability including strong analytical and problem solving abilities

Strong verbal and written communication skills

Knowledge in the application of statistical tools, root cause analysis and/or six sigma methodologies.

Performs all work in compliance with cGMPs and site requirements.

Perform microbiological assays and PCR-based assays for routine testing and qualification/validation of new methods.

Trains less experienced analysts in new and existing procedures, techniques and governmental regulations.

Mentors analysts by providing technical knowledge and support in resolving technical problems.

High technical knowledge and practical application of relevant techniques – classical microbiology techniques

Experience with novel rapid microbial technologies such as PCR or rapid bioburden

Experience with electronic document management systems and laboratory information management systems such as LIMS, SAP,and Trackwise strongly preferred.

Actively participate in visual management, standard work, and 5S activities in the QC

Knowledge and experience in cGMP test methods utilizing and applying compendial monographs and procedures such as USP/NF, EP, JP

Support qualification of instrumentation including coordination of vendor maintenance

Communicate potential improvements and updates to Raw Materials Manager

Scientific understanding and experience with laboratory instrumentation and techniques such as HPLC, pH, titrations, UV, and wet chemical techniques.

Knowledge of GMP compliance requirements for Quality Control Laboratories

Knowledge and practical application of relevant techniques – classic microbiology techniques as well as rapid microbial techniques, desired.

Experience with LWLIMS, MODA, EAMS, QTS and PDOCs is a plus.

Normal lifting, sitting, standing and walking requirements to facilitate testing in a laboratory environment.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Perform bioburden, endotoxin, and TOC assays

Exercise and build basic team effectiveness skills, such as commitment, feedback and consensus management, within the work group.

Act safely and follow Environment, Health and Safety requirements for site and QC laboratories.

Lab Experience in basic analytical methods: HPLC, UV, pH

Knowledge of Advanced analytical methods: Peptide map and Oligosaccharide, ELISA, iCE, CE

Strong oral and written communication skills

Knowledge and understanding of cGMP and industry standards

Sufficient depth of knowledge within their scientific discipline and previous area of experience

Awareness to know their own limitations and seek senior scientist or management guidance when appropriate

Willingness to use personal skills and knowledge to achieve individual and company goals and objectives

Understands the importance of feedback and receives feedback well from management and other colleagues

Makes good decisions based on knowledge of quality systems/technical experience and work is accurate with little to no errors

sufficient depth of knowledge within their scientific discipline and previous area of experience

Performs all work in compliance with cGMPs and site requirements.

May train less experienced analysts in existing procedures, techniques and governmental regulations.

BS in Microbiology or related field with 2+ years of molecular technique experience, preferably in the biopharmaceutical industry

CGMP experience is a plus but not required

Nice to Have: Direct experience with ddPCR technology.

cGMP experience is a plus but not required