Quality Control Director

Basic qualifications:

BA/BS in a science discipline Chemistry / Biochemistry

A general understanding of the disciplines included in QC is required.

Ph.D in a science discipline

Chemistry / Biochemistry

15+ years industrial experience in biopharmaceutical industry, such as Biochemistry, Analytical Chemistry or related field, particularly in the area of assessing physiochemical characteristics of product purity, activity and functional indicators of biological products, along with 10+ years of supervisory and managerial experiences.

Demonstrated leadership capability in laboratory environment with people development and performance management skills.

Fully versed in GMP's, NIH, ICH Guidelines, FDA and other regulatory agency requirements for validation and operations of analytical and stability functions

Preferred qualifications:

Excellent influencing and negotiating skills.

Srong verbal and written communication skills.

Demonstrated success leading a team comprised of varying levels of technical expertise and functions.

Demonstrated ability to think strategically and identify innovative, sustainable solutions to complex business issues.


Lead the responsibility and accountability for the Quality Control (QC) Laboratories to meet testing requirements to support supply chain and site manufacturing.

You will oversees the operation of the following groups in Quality Control: QC Chemistry and Stability, QC Bioassay, QC Microbiology, and QC Raw Materials. These groups are responsible for supporting the QC testing, utility and environmental monitoring and overall support for clinical, CMO and commercial product manufacturing.

You will manage, develop and provide leadership to employees executing analytical testing, stability testing, and analytical instrumentation in the areas of microbiology, molecular biology, protein chemistry, small molecular chemistry and immunochemistry for in process and bulk drug substance.

You will be accountable for the following:

Microbiology, chemistry, biochemistry and stability laboratory testing, review and data release for all raw materials, in-process, bulk drug that meets specifications, and the recommendation for disposition of those not meeting requirements.

The technical and compliance suitability for all testing, including contract lab testing, is conducted appropriately.

Planning and execution of QC testing to ensure agreed upon cycle time are met, associated records are evaluated and data are accurate, valid, and complete.

All QC instrumentation has been qualified, is maintained in a qualified state, and subsequent PM and calibration programs implemented.

The development, validation, and approval of all microbiology, chemistry, biochemistry, stability, and raw materials test methods used in Biopharmaceutical production operations.

Assay technology transfer between R&D and external customers to GMS. Assures consistency of assay procedures between sites.

Current Good Manufacturing Practices (GMP) and adhering to current FDA Guidelines, ICH, and foreign regulations in the areas of microbiology, biochemistry, chemistry, methods, validation and stability.

Ensuring microbiology, chemistry and biochemistry support to the manufacturing, validation, facility and maintenance departments within Biopharmaceuticals Operations.

Continuous improvement and performance management to increase productivity and reduce quality risks.

Interacting with the FDA and other regulatory agencies, worldwide regarding any questions relating to microbiology, biochemistry, chemistry and stability testing.

Ensuring appropriate training is planned, executed, and documented for the QC employees.

Evaluating new equipment for purchase and inclusion in laboratory operations.

The management of the QC employees including performance management, technical and leadership development, and succession planning of department.

Provides in depth technical and scientific advice and guidance to laboratory managers, supervisors and analysts in the Quality Control department.

Approve and monitor contract analysts.

Accountable for ensuring that all QC instrumentation has been qualified, is maintained in a qualified state, and subsequent PM and calibration programs implemented.

Provide support of product filings with regulatory agencies (IND, BLA MAA etc).

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Contact information:

You may apply for this position online by selecting the Apply now button.

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