Job description
AthenPollo is looking for an Associate Director, QC Analytical to support a leading pharma company. This is a Full Time position close to San Rafael, CA. Security, Satisfaction, flexible working hours and Happiness, come along with a handsome package!
Job Title: Associate Director, QC Analytical
Job Type: Full time Permanent.
Location: San Rafael, CA
Summary:
· The Quality Control Analytical Director is responsible for direction of the GMP Quality Control laboratory providing analytical support. This function performs Quality Control testing that supports manufacture and release and stability of drug substance, intermediates, and drug product from CHO cell and bacterial cell production platforms as well as viral vector platforms. In addition, testing support of Contract Manufactured materials is performed.
Responsibilities
· Test and release of Bulk Drug Substance and Drug Product.
· Test of stability samples.
· Testing and support for critical reagents and reference standards.
· Support of CMO testing.
· Provide technical expertise and leadership for the performance of analyses of Manufacturing and Clinical Manufacturing In-Process samples under cGMP to meet specified timelines.
· Directly supervise QC Staff.
· Implement the concepts of Operational Excellence and deploy appropriate systems and processes to enable the efficient operation of a GMP laboratory supporting multiple platforms and modalities.
· Critically analyze and assess data.
· Prepare protocols, summaries, and reports.
Education Required:
· PhD with at least 4 years of experience in a relevant functional area.
· M.S. with at least 6 years of experience in a relevant functional area.
· B.S. with at least 8-10 years experience in a relevant functional area (at least 2 years in Quality Control).
Experience Required:
· At least two years in a cGMP laboratory, Quality Control experience preferred.
· Demonstrate expertise with analytical methods used to assess biopharmaceutical products.
· Lean Labs and, Six Sigma, and 5S experience.
· Computer literacy is required. Experience with Laboratory Information Management systems (i.e., LIMS) is preferred.
Required technical skills:
· Immuno Assays.
· Chromatography.
· Spectroscopy.
· PCR (Polymerase Chain Reaction) based assays.
· Total Organic Carbon Analysis.
Contact: Ismail
Email : ismail(AT)athenpollo.com
I appreciate if you forward your updated word formatted resume for review before we speak.
About Us:
AthenPollo is a fast growing and dynamic organization providing IT consulting and staffing services for over 10 years and committed to becoming one of the nation’s premier IT companies. Our highly skilled and experienced team strives to deliver the highest levels of service and value to our Customers and Consultants. Our client base is comprised primarily of Fortune 100 companies and large system integrators.
Job Type: Full-time
Pay: $180,000.00 - $200,000.00 per year
Benefits:
- 401(k) matching
- Paid time off
- Relocation assistance
Schedule:
- 8 hour shift
- Monday to Friday
Supplemental pay types:
- Signing bonus
Education:
- Bachelor's (Preferred)
Experience:
- Quality Control: 6 years (Preferred)
- cGMP laboratory: 8 years (Preferred)
- Analytical methods: 8 years (Preferred)
- Immunoassays: 4 years (Preferred)
- Spectroscopy: 4 years (Preferred)
- Bioassays: 4 years (Preferred)
Work Location: One location
Speak with the employer
+91 7178898786
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