Pharmaceutical Project Manager Jobs in Rochester, MN

JOB SUMMARY

The Chemist II position responsibilities include both physical and chemical tests on raw materials and finished products according to Current Good Manufacturing Practices (cGMP), United States Pharmacopeia (USP) requirements, the Food and Drug Administration (FDA) and Pharmaceutical Specialties, Inc. Standard Operating and Analytical Procedures.

ESSENTIAL JOB FUNCTIONS

• Perform physical and chemical tests on raw materials and finished products:
  • Infrared Spectroscopy
  • UV-Vis Spectroscopy
  • pH
  • Titrations
  • Quantitation
  • HPLC
  • GC
  • Viscosity (Rheology)
  • Specific Gravity
  • TOC
  • Wet chemistry
  • ICP-OES
• Be able to follow Standard Operating Procedures (SOP).
• Document work in a clear and organized manner.
• Be accountable for the accuracy and validity of test results.
• Follow hygiene and safety rules for the Quality Control laboratory and other departments.
• Maintain a clean lab and assists in purchasing.
• Understand and perform IQ/OQ/PQ and calibration of equipment.
• Develop and validate analytical methods (ICH/USP compliant)
• Assist with new methodology for raw materials and finished products.
• Author and execute method validation protocols and reports.
• Be able to assist with new methodology for raw materials and finished products.
• Author and edit SOP’s.
• Pipetting skills are required.
• Weighing skills are required.
• Must be able to handle chemicals, including strong acids and bases, safely.
• Execute stability protocols including testing.
• Performs related duties as assigned.

COMPETENCIES

• Experience in the area of Pharmaceutical/Cosmetic Chemistry preferred.
• Analytical laboratory experience is required.
• cGMP experience is required.
• Experience with Quality Control testing is preferred.
• Experience with advanced analytical techniques is required.
• Experience with analytical method validation activities is required.
• Able to use judgement to make decisions in carrying out assignments that have impact on safety, quality, regulatory compliance and brand value for PSI and its clients.
• Be self-motivated with ability to work independently with a strong sense of good judgement.
• Good communication skills and the ability to work with multiple departments.
• Able to multi-task between routine testing and other projects.
• Experience revising and authoring technical documents is required.
• Proficiency in MS Word and Excel required.
• Proficiency in other laboratory computer systems, such as OpenLab, is preferred.
• Experience with other computer systems, such as document management and equipment management is preferred.
• Experience in statistical analysis preferred.

SUPERVISORY RESPONSIBILITY

• There are no supervisory responsibilities for this position.

WORK ENVIRONMENT

• While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles and moving mechanical parts. The noise level in the work environment is usually moderate.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential function of this job.

• While performing the duties of this job, the employee may be required to sit and use hands. The employee will also be required to stand, walk, use hands and arms, talk and hear. The employee must occasionally lift and/or move up to 50 pounds. Specific vision requirements are good close vision and to be able to see color at close and far distances.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

USUAL WORKING HOURS

• Monday – Friday, 7:30 a.m. to 4:30 p.m.
• Capability to work extended hours if necessary.

TRAVEL

• This position may be required to travel for educational purposes.

REQUIRED EDUCATION/EXPERIENCE

• Bachelor’s degree in chemistry or related science with 2-5 years of GMP Pharmaceutical/OTC experience.
• Master’s degree in chemistry preferred.
• Demonstrated experience with:
  • Method Validation
  • Stability indicating methods
  • Data integrity compliance
  • Instrument Qualification
• Strong knowledge of chromatography techniques
• Experience writing technical reports

ADDITIONAL ELIGIBILITY QUALIFICATIONS

• Must be able to work with Quality Assurance (QA) department, Research and Development (R&D) department, Production department and Regulatory Department.
• Good communication skills, both written and verbal, are essential when working on interdepartmental projects.
• Language skills- Must have the ability to read and speak English fluently, interpret documents such as directions, instructions, safety rules, and procedure manuals in the English language. Must be able to record written information accurately.
• Must have the ability to apply common sense and understanding to carry out instructions furnished in written, verbal, diagram, or schedule form.

COMPENSATION AND BENEFITS

• This position is eligible for all full-time benefits including:
  • Health Insurance greatly subsidized by the company
  • Dental, Life, Paid Leave and Disability Insurance at no cost to employees
  • HSA, HRA, and Day Care Assistance Plans
  • 401(k) Retirement Plans with Profit-Sharing
  • Bonus opportunities
  • Generous PTO and paid holidays
• The starting salary for this position is $70,000.00 per year

EEO STATEMENT

PSI does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, or any other characteristic protected by law.

WORK AUTHORIZATION

Must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship at this time.

OTHER DUTIES

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities and activities may change at any time with or without notice.