Job Description

We are seeking a detail-oriented and analytical Process Development Associate Scientist II to join our team in Middleton, United States. In this role, you will assist in improving procedures in efficiency, quality and robustness in the areas of enzymes, competent cells, next gen sequencing (NGS) kits and analytical testing to meet business objectives. Additionally, tech transfer and process development and other duties as assigned by management.

• Assist development projects, independently or in conjunction with external partners, in at least some of the following areas in a manner consistent with LGC’s ISO 13485 quality systems;
  • cell line creation, upstream manufacturing, downstream manufacturing, formulation development, or analytical development.
• Process, record, analyse, and report data using good documentation practices.
• Develop batch record and test method templates and SOP’s for manufacturing and quality control to optimize product yield, quality, equipment utilization, and process control while reducing waste, and other key performance indicators.
• Develop stability reports to support product expiration assignment using pre-approved templates and executed
• Assist investigations associated with process deviations, product non-conformances, and customer complaints in a manner consistent with LGC’s ISO 13485 quality system.
• Continuously improve the control strategies of the LGC products to drive efficiency and quality based on sound scientific principles aligned with a Quality by Design framework.
• Effectively communicate technical results to both technical and non-technical audiences both within LGC and to external partners.
• Other duties as assigned

Qualifications

Minimum Qualifications:

• Bachelor’s degree in relevant life-sciences field (molecular biology, microbiology, biochemistry, etc.)—or equivalent education based on industry experience
• Prior success serving in a manufacturing, quality control, or technical team.
• Demonstrated capability in carrying out at least some of the following biologics production processes and principles: familiarity with solution preparation, column preparation, plasmid creation, e. coli cell transformation, e. coli cell culture, homogenization, precipitation, chromatography and/or formulation processes.
• Demonstrated capability in independently carrying out at least some of the following standard analytical techniques: electrophoresis, immunoassays, chromatography, mass spectrometry, spectroscopy.
• Ability to follow standard operating procedures (SOPs) and work instructions to effectively meet production needs
• Ability to gather and organize information, interpret and develop appropriate recommendations for effective action
• Working knowledge and proficiency with Microsoft Office, particularly Outlook, Word, and Excel

Preferred Qualifications:

• Experience with process and analytical equipment for solution preparation, column packing, cell culture, homogenization, precipitation, normal flow filtration. chromatography, and/or tangential flow filtration (e.g. Cytiva & Sartorius systems).
• Experience in drafting of manufacturing production records, standard operating procedures (SOP’s) for production and/or analytical activities.
• Knowledgeable in regulatory guidelines around good manufacturing principles (GMP) and ISO 13485 quality systems.

Additional Information

What we offer (US based-employees):

• Competitive compensation with strong bonus program
• Comprehensive medical, dental, and vision benefits for employees and dependents
• FSA/HSA Pre-tax savings plans for health care, childcare, and elder care
• Deductible Buffer Insurance and Critical Illness Insurance
• 401(k) retirement plan with matching employer contribution
• Company-paid short- and long-term disability, life insurance, and employee assistance program
• Flexible work options
• Pet Insurance for our furry friends
• Improved Parental leave of 8 additional weeks
• PTO that begins immediately
• Town Hall monthly meeting onsite/virtual, Cheer program where employees are recognized for outstanding work, Company wide social events, frequent catered lunches and much more!

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or birthing parent, religion, or belief. Shortlisting, interviewing, and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership.

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