Current Job Openings
Analytical Validation Chemist - Simply Biotech
OVERVIEW
Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.
Immediate opening for a Analytical Validation Chemist with a biotech company in San Diego, CA who possesses:
- BS degree in Chemistry, Biochemistry or related field
- 2+ years of experience in a cGMP pharmaceutical/biotechnology laboratory
- Proficient use of analytical techniques/instruments, such as, HPLC, GC, MS, etc.
Email resumes to mrico@simplybiotech.com or call 949.204.3861.
FULL DESCRIPTION: The analytical method validation chemist is responsible for designing, planning and executing experiments to determine quality attributes of various samples. Analytical methods are validated to ensure compliance with regulatory standards. This role contributes to our commitment to delivering exceptional quality and on-time delivery to our customers.
The selected candidate will be responsible for:
- Generate, review and execute phase appropriate method validation/verification/transfer protocols to meet project timelines and deliverables.
- Execute feasibility (pre-validation) studies to support validation experimental design.
- Write, review and assist in the evaluation of the effectiveness of SOPs and identify necessary changes following validation activities.
- Work closely with Quality Assurance to ensure documents are reviewed and approved in a timely manner.
- Troubleshoot equipment or analytical method issues to minimize downtime and optimize performance.
- Assist with investigation into deviation related to validation studies, identify root causes, issue corrective and preventive actions.
- Assist with training, competency assessment and performance evaluations of laboratory personnel as appropriate.
The selected candidate will also possess:
- Education & Experience:
- Required Education: Bachelor's degree in Chemistry, Biochemistry, Engineering, or a related field
- Experience: Minimum 2 years in cGMP pharmaceutical manufacturing or a regulated environment; peptide manufacturing experience preferred.
- Skills & Competencies:
- Technical Skills: Strong technical knowledge of HPLC, GC and MS, proficient use of Microsoft Office suite of applications (Outlook, Excel, Word, PowerPoint, etc.)
- Soft Skills: Ability to work as part of a team and also independently with minimal to no supervision. Ability to rapidly change focus during times of shifting or changing priorities. Much collaboration across organization and functional boundaries. Excellent organizational, multitasking and communication skills. Discretion
- Teamwork and collaboration
Work Environment & Physical Demands:
- Work Environment: Main work setting is in a laboratory environment requiring Personal Protective Equipment (PPE).
Performance Metrics (KPIs):
- On-Time Validation Deliverables: o Complete validation projects within designated timelines, achieving a target of [e.g., 95%] completion.
- Compliance Rate: o Maintain [e.g., 98%] adherence to cGMP standards, evidenced by minimal deviation or findings during internal and external audits.
- Documentation Accuracy: o Achieve 100% accuracy in validation documentation with no major discrepancies identified during review or audits.
Salary Range: $27-$31.25/hr
For immediate and confidential consideration, please email your resume to mrico@simplybiotech.com or call 949.204.3861. More information can be found at www.simplybiotech.com