Senior Scientist – QC Micro

Are you interested in working with cutting-edge laboratory technology to improve quality and accelerate regulatory compliance?  If so, this Senior Scientist QC Micro role could be an exciting opportunity to explore.

As a Senior Scientist QC Micro, you will ensure that the QC testing of all products is performed to GMP and company standards. This involves microbiological testing (as applicable), analyzing samples, recording, evaluating and reporting data using prescribed procedures with limited or no supervision.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Provide technical support and leadership pertaining to microbiological testing. Verify that results are accurate and complete. Recognize deviations in analytical test procedures and SOP’s. Evaluate product trends and perform analytical testing when necessary.

• Coordinate and direct the use of laboratory resources to meet manufacturing/packaging schedules, distribution and market requirements, stability commitments, and validation/process engineering initiatives.

• Assess the training needs of the staff to coordinate training as necessary.

• Release (approve/reject) analytical data from the laboratory for purposes such as manufacturing, product release to the commercial market, and stability reporting.

• Serve as site representative for specialized technology in interdepartmental and international project teams (e.g., new product development, CAPs, USP).

• Review and provide input into the development of analytical methods, specifications, testing protocols, SOPs, and regulatory documents (NDAs, sNDAs, MAAs, etc.).

• Ensure compliance to regulated procedures.

• Troubleshoot methods and instrumentation.

• Participate/assist in laboratory investigations for out of specification or atypical results.

• Notify and participate with management and interdepartmental teams concerning expanded investigations (external to the laboratory).

 Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's Degree in Micobiology/Biology or related field and 2+ years’ relevant pharmaceutical experience or associate's degree and 4+ years’ relevant pharmaceutical experience or High School Diploma and 8+ years’ relevant pharmaceutical experience.

• Experience of providing QC testing support to at least one value stream

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Knowledge/experience with internal and external audits (cGMP and FDA).

• Ability to lead and encourage continuous improvement.

• Knowledge/experience in performing user acceptance testing for LIFT system.

• Operational knowledge of microbiology (as applicable) laboratory equipment, including ability to diagnose problems and identify appropriate actions.

• Full understanding of the requirements and application of GMP principles in a laboratory environment.

• Effective verbal and written communication on an individual and group basis targeted to appropriately audiences of several levels within GMS.

• Understanding of installation and validation of analytical equipment.

• Understanding of validation and transfer of test methods.

• Developing leadership skills with an ability to form strong win/win partnerships. A demonstrated willingness to collaborate with colleagues to share best practices and /exchange ideas. Supports other teams when required.

• Technical expertise in a broad range of microbiology techniques such as microbial limit testing, validation of raw materials and products, sample preparation techniques, growth promotion testing, peer reviewing of analyst test data, organism identification, environmental monitoring (active air, non-viable particulate, compressed air/gas testing) and understands training methods and practices to ensure that staff are trained to employ these techniques to a high standard (as applicable).

• Developing knowledge and application of the Quality Management System (QMS)

• Demonstrated ability to participate in product projects - command of ICH guidance (ICHQ), GMP requirements and FDA/EMEA regulations. Develop/design lab studies and protocols to be acceptable to regulators, as applicable

• Good understanding of products, data and statistical tools, to be able to discuss and understand the state of the laboratory in relation to the business metrics.