1+ months

Lead Specialist QA Drug Product - Lexington MA

Patheon
Massachusetts Gore, ME 04936
107471BR
Location :
US - Massachusetts - Lexington
:
Job Description
Thermo Fisher Scientific is a rapidly growing, dynamic gene therapy contract development and manufacturing organization that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients
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Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.

The QA Drug Product Lead Specialist is responsible for quality oversight and guidance for Thermo Fisher's manufacturing and testing facility for drug product. The QA Drug Product Lead Specialist will be a key member of QA team and oversee the quality systems to be developed and approved for implementation in the manufacturing and testing operations for drug product. In addition, the he/she will be responsible for ensuring Thermo Fisher bio’s quality policies, practices, procedures standards, and systems for necessary adherence to aseptic production and product management in accordance to the cGXP compliance to US, ATMP and EU regulations.

Essential Duties and Responsibilities: This position is providing lead drug product quality support and oversight for multiple operational activities such as facility build and validation, manufacturing operations, equipment qualification, quality control environmental monitoring and testing reviews and creating procedures to help establish a commerical GMP viral vector manufacturing facililty. The QA Drug Product Lead Specialist will be providing quality leadership for establishing the compliance systems and procedures that will be used to manufacture and test GMP products. This is an opportunity to develop best practices in the quality operations and be involved at the ground up of a new facility buildout. The QA Drug Product Lead Specialist will be the main QA liasion for defined operational activities and lead those groups to successful implementation for drug product operations. Provide quality oversign and support to the operations in the following areas: QA Operations and Compliance QC Release Testing and Product Disposition Facility, Utility and Equipment Validation and Qualification GMP Documentation Manufacturing Operations Floor Support Establishmen of Complinace Expectations Visual Inspection, Vial Labeling Aseptic Operations and Media Fills. BS/MS in Biology discipline and 8+ years of experience in a cGMP environment, with strong knowledge of FDA, EU, ATMP and JP regulations. Experience in setting up GMP operations and systems in new facility is beneficial, in addition to experience in cell or gene therapy drug product. Detail oriented and the ability to communicate effectively, proactively and professionally to clients and members of the management team. Skilled in use of Microsoft Outlook, Powerpoint, Word, Excel and GMP system programs and spreadsheets is mandatory, as is a capacity to follow written procedures, and the ability to read, write, speak, understand and to be understood in English. This position requires the ability to work in a fast paced team environment to meet goals and timelines and as such requires appropriate behavioral characteristics to be effective and successful. Individual must be self-motivated, have excellent quality and management skills and be detail oriented. Individual should also be able to review and provide details to ensure accurate written records, manage time effectively and be organized. Individual must be quick to learn and provide quality and compliance support to the facility and manufacturing operations. Attention to detail, GMP awareness, oversight and guidance is a must. Successful candidate must have the ability to read, write legibly, present data and follow written and verbal instructions in English.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.


If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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Posted: 2019-11-13 Expires: 2020-01-11

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Lead Specialist QA Drug Product - Lexington MA

Patheon
Massachusetts Gore, ME 04936

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