Description
Job Responsibilities:- Oversee the daily activities in the QC Chemistry laboratory to ensure that all cGMP, company specifications, procedures and guidelines are followed.
- Plan and analyze work flow, delegate and prioritize, to ensure tests and projects are completed in a timely manner.
- Direct the identification of assay problems and offer explanations and/or solutions where possible.
- Perform trending and investigations as needed and generate reports.
- Oversee the maintenance of accurate and complete records and review of test record results for accuracy and completeness.
- Provide hands-on guidance in the technical area of chemical laboratory operations when needed.
- Oversee and ensure adequate inventory of lab reagents and supplies.
- Conduct performance reviews of personnel.
- Write and revise laboratory standard procedures as needed.
- Assist in the development of, and performance of method validation studies and production validation studies.
- Designs and executes laboratory protocols necessary to complete Quality and Production-originated projects. Also, provides scientific advice and counsel regarding projects as needed
- Maintains current knowledge of regulatory and related scientific enhancements, trends and advancements through independent reading and training.
Qualifications, and Educational Requirements:
- MS or Ph.D. in chemistry, biochemistry or related scientific field. Ph.D is preferred.
- Minimum of 3 years of managerial or supervisory experience in a biologics, biotech, or pharmaceutical laboratory is required.
- Knowledge of and proficiency in the use of analytical instruments, including troubleshooting skills.
- Strong knowledge of small molecule analytical technologies (e.g. GC, HPLC, AA, etc.).
- Strong knowledge of analytical techniques for biologics or protein-based therapeutics.
- Understanding of immunological based method of analysis desired.
- Prior experience with blood coagulation products and coagulation-specific analytical techniques desired (APTT clotting assays, RCo and vWF analysis, etc.)
- Strong knowledge of cGMP regulations and prior experience successfully handling US and international regulatory agency audits and inspections.
- Ability to follow a wide array of Standard Operating Procedures and ensure laboratory personnel follow all SOPs.
- Experience with investigating Out of Specification events, and writing thorough reports regarding the investigational findings.
- Excellent oral and written communication, as well as good organizational and decision making skills.
- Demonstrated leadership skills with ability to guide, train, coach and develop subordinates.
Please email me your latest resume and salary requirements to be considered
To find out more about Real Staffing please visit www.realstaffing.com