Avid Bioservices Inc (CDMO)

[biopharm]

Job Posting Update : Peregrine/Avid : 42 total now..1 more added




Director, Quality Control Avid Bioservices


31-Jul-2015 to 31-Dec-2015 (PST)
Quality Control
Tustin, CA, USA
Salary
Full Time

Avid Bioservices is an established Contract Manufacturing Organization (CMO) based in Orange County, CA. We are a subsidiary of Peregrine Pharmaceuticals which is on the list of Deloitte & Touche's 500 fastest growing North American technology companies. Avid invites you to bring us your excellent quality control analyst skills and proven abilities in the life sciences industry.

SUMMARY

Responsible for oversight of the Quality Control testing at the Company as well as contract testing labs (CTL) and contract drug substance and drug product manufacturing operations (CMOs). This includes vendor oversight, project management, data review, external auditing, exceptions management (Deviations, CAPAs), and change control. The incumbent will oversee designation of critical quality attributes, trending of method performance as well as in process, release and stability data, and setting of specification. He/she will deploy appropriate process analytical technologies aligned with manufacturing control strategies. This position directs method transfers and method validation and develops corporate quality systems for laboratory controls. This includes ensuring that effective Laboratory Controls are established and managed in compliance with regulations so that the Quality of the company's products is maintained, the patients' interests are protected, and the Company's quality objectives are met.

ESSENTIAL DUTIES & RESPONSIBILITIES

Ensures company's CMOs and labs are in compliance with appropriate Quality practices to meet the desired quality attributes of the Company and ensures the facilities/Quality Systems will pass regulatory inspections.

Oversees method transfers and method validations at contract labs and CMOs.

Provides QC oversight and approval of cGMP QC documents (change controls, deviations, CAPAs, procedures, validation protocols, etc.).

Reviews QC raw data from third parties, and generates Certificates of Analysis.

Participates in cGMP audits of contract testing labs.

Contributes to appropriate sections of Annual Product Review for applicable products.

Authors QC sections of regulatory filings (CTD/NDA/BLA or IND).

Promotes a culture of total quality and operational excellence.

Keeps abreast of industry developments, new technology, forthcoming regulations & competitor activity

Serves as an SME for analytical methodologies, specifications, stability, reference standard, etc. during regulatory inspections.

Proposes quality improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies.

Supports corporate and third party inspection readiness activities.

QUALIFICATIONS

• Bachelor's Degree in science related discipline. Advanced degrees preferred
• 10 -15 years of overall QC experience in a manufacturing environment and a preferable mix of experience in QC Biologics with a pharmaceutical manufacturer, pharmaceutical CMO or testing lab.
• 5-7 years of QC Biologics work experience and 3-5 year of experience with analytical test method transfer, qualification and validation including oversight of outsourced testing.
• Work with small molecules/pharmaceuticals is preferred.
• Experience in implementation and maintenance of laboratory information management systems.
• Demonstrated success in preparation of regulatory submissions to support first in human studies as well as commercial licensure.
• Demonstrated knowledge of Quality Systems and cGMP within an FDA-regulated environment.
• Seasoned professional with broad experience and demonstrated success in interacting with regulatory health authorities during review of regulatory filings as well as during inspections.
• Excellent oral and written communication skills for effectively interfacing with internal and external organizations.
• Proven leadership, negotiation and conflict management skills.

RELOCATION AVAILABLE

Please note this position is based in Orange County, CA and is an onsite role. Competitive relocation assistance within the continental USA will be provided for well-qualified individuals.

EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Peregrine Pharmaceuticals and Avid Bioservices do not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran.

https://peregrineinc.applicantpro.com/jobs/254887.html

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