Scientist

Actalent is hiring a Scientist for their pharmaceutical client who specializes in regenerative therapies for maternal health, GI, and uro-oncology! Candidates must have at least 5-7 years of industry experience with ELISA and other assays, PCR, and flow-cytometry in a GMP environment to be considered for this role.

WHY ACTALENT

• Work with a dedicated career partner specialized in your scientific skill set
• We advocate on your behalf so you get what you want and need out of your job
• Get performance feedback, career advice, and access to ongoing professional development tools
• Build your career and learn new skills through projects as diverse as your curiosity 
• You are eligible for benefits, sick-time, and competitive wages that are paid weekly

Summary:

• Leads and performs experimental design, compendia method qualifications and assay transfers to ensure successful project transfer and performance in the laboratory.
• Executes microbiological methods using, but not limited to, Bioburden testing, Microbial Limits Testing, Antimicrobial Effectiveness Testing, Sterility Testing, and Bacterial Endotoxin Testing, and Microbial and Fungal Identification.
• Executes stability program including pulling, testing, submitting to external laboratories and protocol and report generation.
• Performs training of new hires and assists junior analysts with water sampling, environmental sampling – routine/batch, gas testing, gown qualification and media fills.
• Oversee environmental performance qualification of new cleanroom areas. Performs risk assessments and develops sampling plans and site maps for new cleanroom areas.
• Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance; performs data trending.
• Supports research laboratories on experimental design and method qualification of clinical or preclinical products.
• Perform configuration of new analyses, products and specifications in LIMS as necessary.
• Creates, reviews, and performs authorization of GMP data on paper, logbooks and in LIMS, including but not limited to test results and records, validation protocols/reports, method transfer protocols/reports, test methods, equipment records, process transfer activities, etc. Ensures adherence to regulatory agency requirements, ICH guidelines, and client's standards and procedures
• Monitors the life cycle microbiology instruments for preventative maintenance and calibration - ensuring conformance to specifications. Ensures lab equipment conforms to specifications. Oversees the execution of IQ/OQ/PQ of new purchased instruments in a timely manner. Troubleshoots instruments in the lab when necessary.
• Issues deviations, laboratory investigations, corrective actions change controls, and monitors effectiveness checks in LIMS and in QA-Track.
• Authors SOPs, test method, specifications, developmental protocols, method qualification protocols/reports, annual product reviews and technical reports as needed.

Skills & Qualifications:

• Bachelor of Science Degree in Biological or Environmental Sciences from an accredited College or University is required. Master of Science degree preferred.
• Minimum of 5-7 years of QC laboratory (pharmaceutical or biopharmaceutical industry) with a Bachelor’s Degree or 4 years of industry experience with a Masters degree.
• Strong preference for experience in the following:
• Cell/Gene Therapy (CarT)
• TT Activities
• Cell-Based Assay (ELISA, PCR)
• Rapid Microbial Methods

Benefits:

• Health Insurance (Medical, Vision, Dental)
• 401k
• Financial Discounts and Resources

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.

Salary : $45 - $50