Sr Analyst 1 QC Chemistry 2 Openings

The QC Chemistry Sr. Analyst 1 works with limited direction to execute QC analytical chemistry methods used in biological product manufacturing including chromatography spectroscopy electrophoresis wet chemistry glycan analysis subvisible particle analysis peptide mapping and physical appearance etc. The QC Chemistry Sr. Analyst 1 adheres to GMPcompliant laboratory operations in accordance with regulatory guidelines. This role generates analytical results and identifies laboratory exceptions invalid assays deviations change controls and corrective and preventative actions (CAPAs). The role is primarily responsible for executing routine analytical methods in support of manufacturing supporting laboratory of analytical method transfers and validations and training other QC Chemistry laboratory associates. The ability to effectively communicate and function in a fastpaced highly technical environment is essential to success.

Follow Your Genki to North Americas largest stateoftheart Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine cure or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion energy and drive what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a newlargescale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest endtoend cell culture CDMO provider in North America.

The new site will offer endtoend solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture it will alsoprovideautomated fillfinish and assembly packaging and labeling services. The new stateoftheart facility is located in Holly Springs North Carolina United States.

What Youll Do

Executes physical and chemical analytical testing methods used in biological product manufacturing including chromatography (GC HPLC UPLC SEC) spectroscopy (MS GC/MS LCMS/MS UV UVVis FTIR) electrophoresis (GE nonreducing and reducing CESDS imaged capillary isoelectric focusing (icIEF) wet chemistry glycan analysis subvisible particle analysis peptide mapping and physical appearance etc.
Ensures analytical testing of inprocess drug substance (DS) drug product (DP) and stability samples is performed according to appropriate GMP regulations.
Ensures analytical testing data is captured in LIMS software and data integrity is maintained.
Reports assay performance and assists with implementing improvements that ensure quality and efficiency within QC Chemistry.
Identifies and follows up on excursions and deviations and initiates corrective and preventative actions (CAPAs).
Coordinates and supports QC Chemistry lab activities as needed.
Provides training for QC Chemistry lab associates.
Authors and reviews SOPs and technical reports.
Works crossfunctionally with other QC departments Manufacturing Process Science and Quality Assurance stakeholders to achieve customer and FUJIFILM Diosynth Biotechnologies objectives.
Performs other duties as assigned

Minimum Requirements:

B.S. in Chemistry Biochemistry Biological Sciences Engineering or related science field with 3 years of relevant experience
3 years laboratory experience
13 years GMP laboratory experience
Experience with physical and chemical analytical testing methods used in biological product manufacturing including chromatography (GC HPLC UPLC SEC) spectroscopy (MS GC/MS LCMS/MS UV UVVis FTIR) electrophoresis (GE nonreducing and reducing CESDS imaged capillary isoelectric focusing (icIEF) wet chemistry glycan analysis subvisible particle analysis peptide mapping and physical appearance etc. with cellular and molecular analytical testing methods.

Preferred Requirements:

M.S. in Chemistry Biochemistry Biological Sciences Engineering or related science field with 1 years of experience

Familiar with Raw Material methodology as it pertains to cGMP
Experience with LIMS software

Physical and Work Environment Requirements:

Ability to discern audible cues.

Ability to inspect or perform a task with 20/20 corrected vision visual acuity including distinguishing color.

Ability to stand for prolonged periods of time up to 240 minutes

Ability to sit for prolonged periods of time up to 240 minutes

Ability to conduct activities using repetitive motions that include writs hands and/or fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions.

Will work in warm/cold environments

Will work in small and/or enclosed spaces.

To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM viaemail the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().