Job Description

　　As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

　　Location/Division Specific Information

　　Florence, SC (East)/ Drug Substance Division - DSD is one of the five divisions that make up the Pharma Services Group. We specialize in both small and large molecule development and commercial drug substance services. This allows us to serve the needs of Small/Emerging, Mid-Sized, and Large Pharma sectors globally.

　　Discover Impactful Work:

　　A Qualified candidate will provide Quality Assurance oversight and support for process validation, APQR, and CPV activities. Maintain site compliance using GMP standards. This role will be primarily responsible for reviewing process validation protocols, provide guidance for study execution and analyzing the findings as provided in written reports. Interface closely with Quality Control, Quality Assurance, MSAT, Operations, Engineering and, Project Management, as the need arises.

　　A day in the Life:

　　Provide quality assistance to core teams and act as a quality customer-facing SME as neededSupport the reporting of PV program activities for individual products and/or clients; ensure status, risks, and open issues are tracked and that all collaborators are informed of changes.Help design PV studies to meet the stated intent including development of acceptance criteria.Review PV Plans and protocols.Identify potential root causes of variation and deviations using a systematic approach.

　　Keys to Success:

　　Education

　　Minimum of a BS in Chemistry, Life Sciences, Engineering, Regulatory Affairs or related field in a pharmaceutical environment.

　　Experience

　　Minimum of 5 years of pharmaceutical experience preferably with a plant manufacturing focusGMP and technical writing experience with protocol and report preparationExperience with quality systemsWorking knowledge of validationKnowledge of 21 CFR 110, 21 CFR 211, ICH Q7, and other regulatory standards governing the manufacture of bulk drug substance and drug product.Tech transfer experience

　　Equivalency

　　Combinations of education, training, and relevant work experience may be considered.

　　Knowledge, Skills, Abilities

　　Ability to engage the organization at multiple levels. Depth of experience writing and reviewing technical reports/protocols. Basic knowledge of intermediate to advanced statistical analyses such as T-tests, F-tests, box-plots, understanding p values, etc. as well as control charting, Nelson's/Shewart's rules (or other statistical trending rules), etc. Basic knowledge of mainstream statistical software analysis program such as SAS, MiniTab, or JMP as well as advanced knowledge of process validation principles and their application in biologics drug substance manufacturing. Demonstrated ability to build and maintain productive internal and external facing customer relationships to foster collaboration and continued process improvement

　　Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

　　Apply today! http://jobs.thermofisher.com

　　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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