Xcelience.com

Position Title: Formulator II

Department: Pharmaceutical Development Services

Reports to: Pharmaceutical Development Services Team Leader

FLSA Status: Professional Exempt

General Purpose

Work cross functionally within the department to provide preformulation or formulation development technical support to facilitate the successful completion of development projects.

Essential Duties

• Demonstrate good oral and written skills.

• Work with word processing, spreadsheets, and data analysis.

• Handle math calculations, i.e. be able to calculate percentages, able to calculate free acid/base equivalents from a salt, ability to work with weight/weight or determine molarity etc.

• Work under the direction of a more senior analyst. Able to complete work with minimal supervision. Gain ability to do routine analysis of data. Begin to review others work.

• Keep supervisor aware of the status of the assigned work.

• Document all work in a laboratory notebook following cGMP’s.

• Follow company written policies and procedures including all appropriate SOP’s. Offer suggestions as to where improvements can be made.

• Author and review formulation development batch records. Recognize problems in process or formulation.

• Able to work on multiple projects and meet all project deadlines as needed.

• Understand operating principles behind instrumentation and equipment. Able to trouble shoot when problems arise. Be a trainer for a piece of equipment or an instrument.

• Maintain clean and safe laboratory work environment.

• Develop an understanding of compliance regulations.

• Compare data to specifications. Develops an understanding of Out of Tolerance and Out of Specification situations.

• Develop a proficiency in how to operate the instrumentation and work with Empower software.

• Maintain a positive work environment.

• Maintain training folder up to date.

• Ensure timesheets are filled out appropriately.

• Maintain a positive, professional and confidential relationship with internal and external clients.

• Write and review documents including SOP’s, deviation reports, change controls, and test methods.

• Perform additional duties as assigned by supervisor.

Competency

• Analytical –able to operate a variety of instrumentation. Learn to trouble shoot when problems arise.

• Formulation-able to operate variety of equipment. Learn to trouble shoot and offer suggestions when problems arise.

• Problem Solving – Develops ability to recognize problems and bring them to their supervisor, gathers information skillfully. Starts to offer possible solutions.

• Interpersonal – Listens to others without interrupting; Keeps emotions under control.

• Written Communication – Writes clearly and informatively; Presents work to supervisor effectively; Able to read and understand written information.

• Ethics – Works with integrity and ethically; upholds organizational values.

• Cost Consciousness – Works within approved budget; conserves organizational resources.

• Quality – Demonstrates accuracy and thoroughness, Applies feedback to improve performance, Monitors own work to ensure quality.

• Safety and Security – Reports potentially unsafe conditions; Uses equipment and materials properly.

Supervisory Requirements:  none

Qualification

Education and/or Experience Associates degree with 8 – 10 years experience, Bachelor’s degree and 2 – 6 years of relevant experience or Masters Degree with 0 – 3 years experience.

Language Skills Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.

Ability to collect and record data. Ability to effectively present information to management and to clients.

Mathematical Skills – Able to do some calculations such as percentages. Ability to use mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to understand mathematical operations to do such tasks as frequency distribution, determination of RSD’s etc.

Reasoning Ability – Ability to identify problems, collect data, and establish facts and discuss possible solutions. Ability to follow technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills To perform this job successfully, an individual should have knowledge of Word Processing software.

Certificates, Licenses, Registrations No certifications needed.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include Close vision, Distance vision, Peripheral vision, Depth perception and Ability to adjust focus. While performing the duties of this Job, the employee is regularly required to use hands to handle or feel. The employee is frequently required to stand; sit and reach with hands and arms. The employee is occasionally required to walk; climb or balance and stoop.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently asked to work with toxic or caustic chemicals. The noise level in the work environment is usually moderate.

Additional Information

EXPECTATIONS

The Employee in this position is expected to support and enforce the values and goals of Xcelience by exhibiting mutual trust, genuine concern and respect for people, integrity and commitment to quality and meeting the expectations of our Clients. Additionally, employees are expected to comply with Xcelience’s policies and procedures and to conduct themselves in a professional manner at all times.