Impress employers and recruiters.
Choose from hundreds of resume examples.

Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

This position performs analyses of materials, drug substances, and drug products following cGMPs. It supports method development and validation activities with supervision, and maintains and proposes improvements to lab quality systems.

Responsibilities

• Performs, interprets, evaluates, and records routine and some non-routine analytical lab tests of materials, drug substances, and drug products following CGMPs.
• Executes protocols and experiments as written.
• Maintains instruments and equipment, including setup and sample testing.
• Performs routine calibration of instrumentation.
• Ensures an adequate supply of test materials for daily testing.
• Maintains and updates training records in a timely manner.
• Supports method development/validation and method transfer activities.
• Proactively identifies issues, communicates them, and proposes/implements solutions.
• Performs laboratory troubleshooting, proposes solutions, and implements them with direction.
• Supports investigations, proposes solutions, and writes investigations with supervision.
• Recommends and assists in the implementation of procedural improvements.
• Supports lab systems as assigned and maintains laboratory in compliance with SOPs, cGMPs, HS&E requirements, and FDA, DEA, USP, EP, and OSHA regulations.
• Implements training to ensure GMP, regulatory, and customer requirements are met, promoting first-time-right delivery.
• Monitors the effectiveness of training efforts and modifies approaches to ensure learning objectives are achieved.
• Distinguishes between training and non-training needs and works with Supervisor/Manager to recommend appropriate solutions to performance problems.
• May support/provide input for investigations, troubleshooting, and method development/validation with supervision.
• Writes basic investigations with supervision.

Requirements

• A.A.S. with 5+ years or B.S. with 2+ years of experience in chemistry or a related science discipline.
• Experience with laboratory analytical techniques.
• Ability to operate and maintain HPLC systems and/or dissolution equipment and spectroscopic instrumentation (UV/Vis, FTIR).
• Experience with HPLC method development & validation in a pharmaceutical environment is desirable.
• Experience in written notebook documentation practices.
• Basic Outlook skills including creating/sending messages, working with address books, message handling, creating/using personal folders, scheduling appointments, working with meeting requests, and managing tasks.
• Intermediate Microsoft Word skills including producing basic business letters, simple tables and charts, checking spelling, setting tabs, changing page orientation, sorting, saving, opening, organizing electronic files, creating moderately complex documents with tables and graphs, mail merging, applying page setup functions, creating an index/table of contents, using search & replace, and printing labels and envelopes.
• Intermediate Excel skills including using workbooks, creating simple formulas, inserting/deleting data, creating/editing charts, filtering/sorting lists, formatting data, linking data, changing page orientation, adding headers/footers, inserting rows, entering/sorting data, and producing graphs and charts.
• Familiarity with LIMS and experience with instrument operating software.
• Must demonstrate visual acuity, color recognition, and finger dexterity.
• Ability to read, write, and communicate in English.
• Work responsibilities involve chemical and biological agents with assigned biological and chemical hazards.
• Sitting approximately 50% of the day and standing approximately 50% of the day.
• Work responsibilities may involve repetitive use of the hands through keyboarding, simple grasping, and fine manipulation.
• Occasional lifting of up to 35 pounds.
• Normal office environment and occasional controlled environment work that may require removal of jewelry and cosmetics.

Skills

• Laboratory analytical techniques
• HPLC systems operation and maintenance
• Dissolution equipment operation and maintenance
• Spectroscopic instrumentation (UV/Vis, FTIR) operation and maintenance
• HPLC method development
• HPLC method validation
• Written notebook documentation
• Microsoft Outlook
• Microsoft Word
• Microsoft Excel
• LIMS
• Instrument operating software

Location

• Rochester, NY

Work Type

• Full-time

Experience Level

• Associate
• Bachelor's

Education Level

• A.A.S.
• B.S.

Salary/Compensations

• 22.00 - 25.00 USD per hour

Benefits

• 100% employer-paid medical premiums
• 401(k) contributions: 6% match plus an additional 4% company-funded contribution
• HSA contributions with wellness incentives
• Annual performance bonuses
• Merit increase eligibility

About the Company

• French pharmaceutical industrial group striving to make healthcare solutions accessible.
• World leader in sterile single dose with 10 sites on 4 continents and over 2400 employees.
• Unither Manufacturing LLC. in Rochester, NY specializes in Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets, and Capsules, with over 360 employees.
• Dynamic company driven by a spirit of victory, pursuing strong growth while maintaining close relationships with customers and employees.
• Culture based on 5 values: Respect, Responsibility, Trust, Courage, and Innovation.
• Committed to granting employees high autonomy and encouraging initiatives.
• Provides working conditions and atmosphere conducive to employee development and potential expression.
• Site values the meaning of work and entrusts employees with a high level of responsibility.

Equal Opportunity

• Unither is an Equal Opportunity Employer.
• Committed to providing reasonable accommodations for qualified individuals with disabilities.
• Ensures equal employment opportunity for all applicants.