- Responsible for the operation of Vanrx SA25 Vial Filling Isolator.
- Responsible for overseeing the formulation of the bulk drug product in accordance to procedures.
- Responsible for visual inspection and labeling of filled bulk drug product vials in accordance to procedures.
- Responsible for writing, reviewing, and/or updating Standard Operating Procedures (SOPs) and Batch Production Records (BPRs).
- Document and maintain activity records according to cGMP regulations and ensure team members are trained.
- Help implement project safety and quality assurance programs in collaboration with senior staff and EH&S.
- Ensure proper documentation and execution of Batch Production Records for assigned projects.
- Maintain confidentiality of proprietary company information.
- Participate in incident investigations.
- Maintain an effective working relationship with others.
- Perform all other duties as assigned.
Required Skills & Abilities:
- Excellent oral and written communication skills as well as excellent interpersonal and organizational skills.
- Demonstrated leadership, coaching and mentoring skills.
- Ability to train others to perform and maintain cGMP standards
- Strong proficiency with Microsoft Office applications.
- Experience working in cleanroom environments.
- Must have flexible work hours, and be willing to work outside of normal, scheduled hours, as necessary. Must be able to work alternative shift hours and weekends as required.
- Self-discipline and good attention to detail.
- Excellent math and computer skills.
- Must have exceptional planning skills and be willing to interface with colleagues in many different roles and functions throughout the manufacturing facilities and lead projects.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee, in order to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:
- Experience prolonged standing, some bending, stooping, and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
- Ability to lift up to 25 pounds; frequently, and up to 50 pounds; on occasion.
- Attendance is mandatory.
- Master’s Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field with 4 years relevant experience of which 2 year must be in a GMP environment as a lead or supervisor; OR
- Bachelor’s Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field with 6 years relevant experience of which 2 year must be in a GMP environment as a lead or supervisor; OR
- High School or Associates Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 10 years relevant experience of which 5 year must be in a GMP environment.
- Six Sigma Certification
- Cross training with downstream processes or other identified functional areas.
- Biotechnology Certificate
- SAP experience
- Train the Trainer Certification
- Drug Product experience
- Handling of Live Virus