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Lead QC Microbiology Engineer
4 months ago
Lead QC Microbiology Engineer
At Minaris Regenerative Medicine our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.
The Lead QC Microbiology Engineer position will report into the Manager of Microbiology. Incumbent will be responsible for sourcing out new in-house methods, development of test protocols and new standard operating procedures, product qualification, vendor communication, and creation of training materials for new test methods.
Essential Functions and Responsibilities
Below is the summary of the role responsibilities. This is not an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice.
Core responsibilities include, but not limited to, performing in-house microbiology test, sourcing out new in-house methods, development of test protocols and new standard operating procedures, product qualification, vendor communication, creation of training materials for new test methods, and supporting timely review and release of Environment monitoring data including the trend reports.
Qualifications
BS, MS, PhD with Microbiology, or related science.
BS with 8+ years, or MS with 6+ years’ experience in Pharmaceutical Microbiology, Biotech, life science, or suitable field preferred.
Comprehensive knowledge of regulatory requirements and standards (FDA, EU, ICH, ISO, USP)
Proficient with method verification/method transfer and equipment/instrument validation.
Maintain current awareness and contribute to current scientific literature and actively apply new concepts and technologies. Preferred working experience in gene therapy. Previous biologics contract manufacturing organization or CDMO experience preferred.
Microsoft Office experience (Word, Excel, PowerPoint, etc.).
Able to work independently to execute new test method. Able to rigorously analyze and interpret data. Able to support multiple projects and strong organizational and problem-solving skills.
Competencies/Candidate Profile
Excellent verbal and written communication skills; clear and concise technical writer
Ability to set deadlines and prioritize work for self, group members, and support groups involved.
Ability to train others in the area functions needed for performance of job and review work for accuracy and alignment with procedures.
Ability to work in a team environment and interact with various departments.
Strong computer knowledge is required, including Microsoft Office and the ability to learn relevant internal computer systems.
Strong business acumen
Ability to think strategically and tactically (detail-oriented)
Strong collaborative and influencing skills.
High analytical and problem-solving skills
Strong written and oral communication skills
Meeting management/facilitation skills/teamwork
The ability to multi-task a team is essential.
Flexible and able to adapt to company growth and evolving responsibilities.
Lead by influence to drive quality culture.
Supervisory Responsibility
This job has no supervisory responsibilities.
Quality Requirements
Build Quality into all aspects of your work by maintaining compliance to all quality requirements.
Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
Attend all required Quality & Compliance training at the specified interval.
Minimum Required Training to be Completed within the First 90 Days of Hire
Must understand and adhere to Good Documentation Practices (GDP)
Maintain 100% training records for all required training.
Valid driver’s license and clean driving record
Working Environment
Must have the ability to work in a team-oriented environment and with clients.
While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.
Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noise.
