Chemist II: Reference Standards & Compliance

Bausch & Lomb GmbH; City of Rochester (NY); On-site; USD 71,000 - 80,000; Full time

Benefits offered by this job

Health, wellness & retirement benefits

Paid time off

Learning opportunities

Job summary

Bausch & Lomb GmbH in Rochester, NY seeks aReference Standards program analyst to evaluate materials, determine characterization methods, coordinate testing, and author protocols and reports.

The role requires a BS in Chemistry or related field (or AAS with experience) plus strong analytical and cGMP knowledge, and LIMS experience. We offer comprehensive benefits and growth opportunities.

Qualifications

• Bachelor's degree in Chemistry or related field preferred with 2+ years in FDA-regulated industry.
• AAS in Chemistry or related field with 5+ years in pharmaceutical or medical device industry.
• Equivalent combinations of education, training and experience may be considered.
• Candidates with 5+ years in pharma/medical device may be considered in lieu of degree.
• Strong analytical problem solving and data integrity skills.
• Working knowledge of cGMP requirements and data integrity principles.
• Excellent written, verbal, and organizational skills.
• Experience with LIMS and cross-functional teamwork.

Responsibilities

• Serve as the primary analyst supporting the internal Reference Standards program.
• Coordinate testing of reference standard samples with laboratory analysts.
• Author characterization protocols, characterization reports, and reference standard protocols.
• Review reference standard protocols for compliance with pharmacopeial requirements.
• Continuously improve methods and reference standards; stay updated with updates.
• Identify opportunities to reduce external testing costs by insourcing when feasible.
• Participate in Reference Standard Review Board meetings and collaborate cross-functionally.
• Maintain training and a safe, compliant work environment.

Skills

Analytical problem solving

Written & verbal communication

Cross-functional teamwork

cGMP knowledge

Data integrity

LIMS experience

Education

BS in Chemistry or related field

AAS in Chemistry or related field

Equivalent combinations of education/experience

5+ years in pharma/medical device industry (as substitute for degree)

Tools

LIMS

Job description

Bausch & Lomb GmbH in Rochester, NY seeks aReference Standards program analyst to evaluate materials, determine characterization methods, coordinate testing, and author protocols and reports.

The role requires a BS in Chemistry or related field (or AAS with experience) plus strong analytical and cGMP knowledge, and LIMS experience. We offer comprehensive benefits and growth opportunities.