QC Raw Material Scientific Sr. Associate/Associate (Contract) 29688

The QC raw material scientific/sr. scientific associate operates independently to perform raw material testing such as appearance and ID of materials including but not limited to small molecules, chemicals, solvents and gases. The associate will be responsible for supporting shipment of samples to external contract testing labs which includes - process and receipt in LIMS, packaging of samples at appropriate storage conditions, completion of respective vendor sample submission form, and processing of final results in LIMS/associated internal forms. The associate will also be responsible for performing particle characterization of foreign particulates found in various sample types (i.e. finished product, cryopreserved intermediate, water flushing). The ideal candidate will have expertise in particle analysis techniques and instrumentation as well as conducting various raw material analytical testing.

** The identified candidate will need to pass a vision and color blindness test **

Key Duties and Responsibilities:

• Works with multiple functional groups to meet business needs.
• Performs internal raw material testing per associated material specification to support GMP operations
• Supports shipment of samples to external contract testing labs for respective testing per associated material specification
• Characterize sub-visible and visible particulates by FTIR and optical microscopy
• Individual should be capable of writing reports related to work completed in laboratory.
• Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatoryprocedures and guidelines. 
• Problem solving, either independently or with assistance pertaining to extraction of particulates and/or instrumentation problems. 
• Performs work assignments accurately, and in a timely and safe manner
• Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP)
• Performs self and peer review of the data for accuracy and compliance

Knowledge and Skills:

• Team focused, demonstrate high level of integrity, and have strong collaboration, communication, interpersonal and organizational skills
• Prior experience using FTIR and raw material testing experience
• Knowledge of multiple applicable techniques such as: particle size, microscopy
• Proficient in Microsoft Excel and Word 
• Proven ability in technical writing skills 
• Proven problem solving and troubleshooting abilities 
• Good written and oral communication skills 
• Ability to work in a collaborative work environment with a team
• Experience being involved with analytical investigations/deviations 

Education and Experience:

• Bachelor’s degree in a biologic field, life sciences, engineering, chemistry, pharmaceutical science.
• At least 5 years’ experience in the pharmaceutical industry, biotech industry, life sciences industry.
• Particle ID and raw material experience is a plus

Work Hours

• Standard Hours: Monday – Friday 8:00am - 4:30pm (with flexibility to support second shift / weekends as needed)

$35-42/hr (Associate) $42-48/hr (Sr. Associate)

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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