Scientist, Eye Care

Role Summary

Scientist, Eye Care will lead manufacturing projects to improve process efficiency, yield, quality, cycle time, and cost. They will provide technical support for manufacturing investigations and laboratory experiments, conduct structured problem-solving investigations, and document deviations with impact assessments. They will lead process validation for technology transfers and operational changes, and support experimental and validation lot execution in compliance. The role includes collaboration with cross-functional teams and supporting regulatory audits and submissions, with accountability for EHS performance.

Responsibilities

• Lead manufacturing projects to enhance process efficiency, yield, quality, cycle time, & cost reduction.
• Utilize statistical process control to monitor performance & develop plans to increase robustness & quality control.
• Provide technical support for manufacturing investigations & laboratory experiments.
• Conduct structured problem-solving investigations.
• Document process deviations & assess impact on quality & yield.
• Participate in cross functional teams by handling project management tasks.
• Lead process validation for technology transfers, operational changes, & new technologies.
• Support experimental & validation lot execution, maintaining compliance with current procedures & regulations.
• Provide technical support during regulatory audits & submissions & demonstrate accountability for EHS performance.

Qualifications

• Education & Experience: Must possess a BS in Chemistry, Biology or Engineering (Chemical, Mechanical, Bio-chemical, or other relevant scientific field) or equivalent education & 5 years of experience as a scientist in the pharmaceutical/medical device/chemical industry.
• Experience: Of experience required, must have 5 years:
  • applying fundamentals of pharmaceutical drug product process including sterile/aseptic product manufacturing, media fill, sterilization, fill finish operations, & cGMP;
  • performing design control, process validation, & technology transfer;
  • providing regulatory support for IND and BLA submission;
  • performing statistical analysis using Minitab, JMP, Lean Six Sigma);
  • experience in project management working in a cross functional organization; &
  • preparing scientific documents & reports, orally & in writing, for peers, business stakeholders, management & vendors.
• Alternative: MS or equivalent education Chemistry, Biology or Engineering (Chemical, Mechanical, Bio-chemical, or other relevant scientific field), & 1 year of experience as a scientist in the pharmaceutical/medical device/chemical industry.
• Of experience required, must have 1 year of each of (i), (ii), (iii), (iv), (v), (vi) & (vii). Work experience may be gained concurrently. Will accept reasonable combination of education, training & work experience.

Education

• BS in Chemistry, Biology or Engineering (Chemical, Mechanical, Bio-chemical, or other relevant scientific field) or equivalent education & 5 years of experience as a scientist in the pharmaceutical/medical device/chemical industry.
• Alternatively, MS or equivalent education Chemistry, Biology or Engineering (Chemical, Mechanical, Bio-chemical, or other relevant scientific field), & 1 year of experience as a scientist in the pharmaceutical/medical device/chemical industry.

Skills

• Project management in a cross-functional organization
• Statistical analysis using Minitab, JMP, Lean Six Sigma
• Structured problem-solving and root-cause analysis
• Technical documentation and communication of scientific data
• Regulatory support for IND/BLA submissions
• Process validation and technology transfer
• Quality and compliance in manufacturing and laboratory environments
• Environmental, health and safety (EHS) accountability