Senior Development Chemist

About the role

We are seeking a Senior Method Validation and Development Chemist to join our team at Unither Manufacturing LLC. in Rochester, NY. This position is responsible for method validation and development, project management, and analytical support.

Responsibilities

• Solutions that Minimize Commercial Lab & Manufacturing Downtime
• Conducts incident investigations to determine root cause
• Works with the appropriate discipline to identify corrective/preventative measures
• Collaborates with internal groups to determine and implement preventative measures
• Coordinates documentation required at the completion of investigations
• Collaborates with internal groups to implement preventative measures
• Identifies, offers, and implements plans to prevent and overcome analytical issues
• Provides analytical leadership and consultation internally
• Serves as analytical lead for customer and government regulatory agency site inspections
• Methods for New Products & Product Transfers
• Coordinates work of lab personnel to support on-time delivery of analytical data to projects
• Functions as Analytical Representative and SME on project teams
• Performs analytical method development, validation, and project support from design to execution
• Provides scientifically sound, clearly written analytical data packages/reports suitable for submission
• Writes protocols and reports
• Reviews and checks analytical data generated by peers and maintains integrity of data
• Internal Analytical Support
• Provides analytical solutions to manufacturing troubleshooting, process development, and improvements
• Evaluates regulatory changes to existing methods
• Investigates and recommends analytical instrumentation purchases
• Suggests and leads process improvements to refine current systems and improve efficiencies
• Laboratory Training Program
• Buils systems that translate training and development needs into appropriate, cost-effective learning and development interventions
• Develops methods to transfer information and techniques from training sessions to actual on-the-job performance
• Evaluates training effectiveness by using pre-test and post-test measures, interviews, and examining various records and reports; and recommends modifications to training as appropriate
• Delivers one-on-one or group training to individuals on assigned processes

Qualifications/Experience

• Bachelor’s degree in life science or closely related field
• 5-10 years of experience working in analytical laboratory experience with knowledge and/or familiarity with HPLC, GC, GC/LC-MS, FTIR, UV/Vis, SEM, CE, Chiral Separations, dissolution
• 3-5 years in Regulated Industry, Pharm preferred
• Proven success in method development and validation

Skills

• Statistical data evaluation to include experimental design (plus)
• Basic Outlook and PowerPoint skills
• Intermediate MS Word and MS Excel skills

Physical Requirements/Environment

• Must demonstrate visual acuity, color recognition, finger dexterity
• Work responsibilities involve chemical and biological agents that have assigned biological and chemical hazards
• Sitting approximately 50% of day and standing approximately 50% of day
• Occasional lifting of up to 35 pounds
• Normal office environment and occasional controlled environment work that may require removal of jewelry and cosmetics
• Occasionally subjected to weekend, holiday and irregular hours

Compensation

The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations. A Smarter Total Compensation Package At Unither, your base salary is just the beginning. Our Total Rewards include: 100% employer-paid medical premiums (a $2,000–$6,000+ annual value) 401(k) contributions: 6% match plus an additional 4% company-funded contribution HSA contributions with wellness incentives And more—because we invest in your health, your future, and your peace of mind. It’s a package designed to reward impact—not just hours worked.