Apex Life Sciences is actively seeking a Formulation Chemist in the Greenville, SC area for a permanent opportunity. This individual will be responsible for all aspects of product development for pharmaceutical solution and suspension products, such as formulation development, sourcing raw materials, and oversee the process from scale-up through launch.
ESSENTIAL DUTIES AND RESPONSIBILITIES
1. Fulfills the essential tasks and responsibilities on a daily basis. This position is considered full time (40 hours a week on average, sometimes more) position. Follows all policies, procedures, SOPs, cGMPS, Work Instructions, and supervisor instructions. This duty is performed daily, about 100% of the time.
2. Formulates new and/or improved oral solution and suspension products. Interpret analytical and process data to further develop and optimize formulations and manufacturing processes. This duty is performed daily, about 100% of the time.
3. Assists in the development and/or performs all testing requirements on new formulations and develop specifications. This duty is performed daily, about 100% of the time.
4. Collaborates with the Manufacturing and Validation Departments in the scale up and validation activities. This duty is performed weekly, about 75% of the time.
5. Write and review technical documents including formulation development protocols and reports, SOP's, method validation/verification protocols and reports and other documents. This duty is performed weekly, about 50% of the time.
6. May assist and/or perform method validations for new formulations. This duty is performed weekly, about 50% of the time.
7. Communicates, in a timely fashion, all information regarding formulation and project status to PD management. This duty is performed daily, about 100% of the time.
8. Process development in support of commercial scale up. This duty is performed weekly, about 50% of the time.
9. Perform any other related duties as required or assigned.
To perform this job successfully, an individual must be able to perform each essential duty mentioned satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
EDUCATION AND EXPERIENCE
Four year college degree in a scientific field such as Chemistry or Biology plus 3 years related experience or training, or equivalent combination of education and experience.
Ability to read and understand documents such as policy manuals, safety rules, operating and maintenance instructions, and procedure manuals; Ability to write routine reports and correspondence.
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
CRITICAL THINKING SKILLS
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal, logical or scientific symbolism such as formulas, scientific equations, and graphs. Ability to deal with a variety of abstract and concrete variables.
Under direction where a definite objective is set up and the employee plans and arranges own work, referring only unusual cases to supervisor.
Limited responsibility with regard to specific assignments in planning time, method, manner, and/or sequence of performance of own work operations.
Performs work operations which permit infrequent opportunity for decision-making of minor importance and which would only affect the operating efficiency of the individual involved to a slight degree.
ANALYTICAL ABILITY / PROBLEM SOLVING
Moderately directed. Activities covered by wide-ranging policies and courses of action, and generally directed as to execution and review. High order of analytical, interpretative, and/or constructive thinking in varied situations.
Regular use of highly complex machines and equipment; specialized or advanced software programs.
Occasional routine contacts with persons outside the organization. This would include contacts with suppliers, mail service, etc.
Contacts of considerable importance within the department or office, such as those required in coordination of effort, or frequent contacts with other departments or offices, generally in normal course of performing duties. Requires tact in discussing problems and presenting data and making recommendations, but responsibility for action and decision reverts to others.
SOFTWARE SKILLS REQUIRED
Basic: Other, Spreadsheet, Word Processing/Typing
The following work environment characteristics described here are representative of those an employee encounters while performing essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the functions of this job, the employee is regularly exposed to fumes or airborne particles; frequently exposed to toxic or caustic chemicals; and occasionally exposed to extreme heat.
The noise level in the work environment is usually moderate.
Experience with analytical instrumentation including IR, UV/VIS, HPLC and GC. Must be experienced with USP, FDA and cGMP regulations and/or requirements. Understanding of formulation development and product development cycle. No FDA sanctions.