Lead Scientist

BuzzClan; Round Rock (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

BuzzClan is seeking a Lead Scientist (Analytical) in Round Rock, TX to independently lead complex QC activities and guide the team. The role involves solving analytical problems, developing new methods, and overseeing OOS investigations, with 100% on-site work.

Required qualifications include an advanced degree in chemistry or a life sciences field and 4+ years of related experience; PhD candidates with no work experience are acceptable.

Qualifications

• BS/MS/PhD in chemistry or life sciences is required.
• 4+ years of related work experience for BS/MS; PhD with no prior experience is acceptable.
• Experience with ISO/GMP/GLP environments is a plus.

Responsibilities

• Perform analytical testing of finished products, raw materials, and in-process samples per SOPs.
• Develop investigational strategies for OOS investigations and write OOS reports.
• Lead method development and analytical validations/technical studies.
• Maintain instruments and perform qualifications and troubleshooting.
• Document work and maintain audit-ready QC lab condition.
• Train staff and contribute to process improvements and quality systems.

Skills

Analytical methods

Technical writing

OOS reports

Leadership

Troubleshooting

Education

BS/MS/PhD in chemistry or related life science

Tools

Instrument qualifications

Job description

The Lead position requires a higher level of technical experience and the ability to independently lead complex QC activities and provide technical guidance to the team. Look for demonstrated experience leading technical investigations, troubleshooting complex analytical issues, and providing technical guidance to other analysts.

100% on-site

Scope of Responsibility:

The Lead Scientist (Analytical) is responsible for performing analytical testing of finished products, raw materials, custom analytical services, and in-process samples. The Lead Scientist will use their experience and education to solve problems, optimize processes, develop new processes and methods, and assist in the development and analysis of new products. The Lead Scientist will also develop investigational strategies and participate in Out of Specification (OOS) investigations.

Purpose of the Position:

• Conduct work in a professional manner.
• Undertake an expanding range of analytical analyses in support of custom and new products.
• Lead or participate in technical problem solving, implementation of new processes and initiatives.
• Complete laboratory maintenance and housekeeping activities efficiently and in accordance with safety and quality policies and procedures.
• Complete laboratory equipment calibrations, verifications and maintenance activities on schedule with required documentation.
• Train on and demonstrate understanding of multiple analytical techniques.
• Participate in development of and demonstrate understanding of departmental goals.

Essential Job Functions:

• Perform analytical testing of finished products, raw materials, custom analytical projects, and in-process samples as directed in standard operating procedures and methods.
• Develop and execute investigational strategies in OOS investigations and write OOS reports.
• Lead or participate in method development.
• Lead and participate in analytical method validations and technical studies.
• Perform instrument qualifications and maintenance/troubleshooting of analytical instruments.
• Lead or participate in improvement of processes, procedures and systems.
• Document work in accordance with MilliporeSigma and regulatory requirements.
• Maintain the QC Laboratory in a state of audit readiness that includes a clean and organized work environment.

BASIC QUALIFICATIONS

Education:

• BS or MS or PhD in chemistry or relevant life science related field.

Knowledge and Skills:

Experience:

• BS or MS will have 4+ years prior work experience in a related field
• PhD and no prior work experience.
• Knowledge of the ISO 9001, ISO 17025 and ISO 17034 requirements.
• May have prior work experience in a GLP, GMP and/or ISO environment.
• May have knowledge of quality system requirements of the medical device, pharmaceutical and/or clinical industries.

Knowledge and Skills:

• The Lead Scientist has demonstrated knowledge and experience in analytical methods and interpretation of analytical results.
• Excellent verbal and technical writing skills. Ability to write procedures, reports, OOS reports, training documents, technical presentations, etc.