cGMP Project Manager
cGMP Project Manager
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Job Description
- Demonstrates and promotes the company vision
- Regular attendance and punctuality
- Applies GMP/GLP in all areas of responsibility as appropriate
- Represents the single point of control for research studies and projects
- Coordinates efforts of the study team
- Manages client relationships
- Compiles and communicates study requirements to appropriate study team members
- Develops protocols and ensures that the protocol and report including any changes are approved and in compliance with appropriate SOPs GXPs quality agreements and regulatory agency guidelines
- Provides relevant information to assure accuracy of forecast and revenue recognition reviews cost estimate and financial information for accuracy
- Monitors progress and status of assigned studies. Ensures that all experimental data including observations of unanticipated responses to the test system are accurately recorded and verified
- Leads efforts with the study team to troubleshoot and solve assay problems as necessary
- Reviews reports for scientific accuracy and completeness
- Provides technical/scientific guidance and leadership to ensure project completion and to other areas of the company
- Performs post-project analysis of study performance
- Leads and sponsors client visits
- Responsible for ensuring that any unforeseen circumstances that may affect the quality and integrity of the study are identified and documented as they occur and corrective action is taken
- Responds to unscheduled deadlines client needs and crises without neglecting other duties
- Co-authors scientific papers/posters which are published or presented at scientific meetings
- Assures on-time delivery of high quality data and reports
- Evaluates data to assure regulatory guidelines and scientific expectations are met
- On a broad basis able to apply appropriate chemistry principles theories and concepts within the field of discipline. Applies a working knowledge of related disciplines
- Trains less-experienced staff
- Travels to various EFII and client locations to support studies and projects
- Travels to technical conferences to represent Eurofins
- Conducts all activities in a safe and efficient manner
- Performs other duties as assigned
Qualifications :
To perform this job successfully the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge skill or ability required.
- At least 6 months of related experience with PhD in chemistry microbiology or equivalent degree or 6-10 years of relevant education/experience without PhD
- GMP experience preferred
- Skilled in chemistry field
- Knowledge of regulatory agency guidelines
- Proficiency in project management skills
- Ability to conduct review of related literature and references to obtain the required information and subsequently apply it
- Skilled in data interpretation and report writing
- Skilled in performing scientific presentations and preparing scientific publications
- Excellent interpersonal skills
- Ability to learn new tasks
- Ability to think critically and solve problems quickly and efficiently
- Skilled in the appropriate chemistry field
- Knowledge of regulatory agency guidelines
- Proficiency in project management skills
- Ability to conduct review of related literature and references to obtain the required information and subsequently apply it
- Skilled in data interpretation and report writing
- Skilled in performing scientific presentations and preparing scientific publications
- Excellent interpersonal skills
- Ability to learn new tasks
- Ability to think critically and solve problems quickly and efficiently
Additional Information :
What we offer: As an employer were keen to look after our people with as much dedication as they look after our patients. Thats why we offer competitive salaries excellent training and exceptional career prospects. Were a growing and ambitious company so there is huge potential here to develop with us and enjoy fantastic rewards in your career.
Your data:
As part of any recruitment process the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations.
Eurofins is a M/F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.
Eurofins USA Food Testing is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
