Job Description

TITLE:                           PDM Associate

REPORTS TO:             Scientists/Group Leaders

DEPARTMENT:             Pharmaceutical Development and Manufacturing (PDM)

JOB SUMMARY:

PDM Associate will work under general direction, assisting the research investigators by performing moderately complex research and experimentation following established protocols.

ESSENTIAL DUTIES/RESPONSIBILITIES:

1.    Perform cGMP manufacturing of Sterile and Non-sterile dosage forms.

2.    Responsible for ordering GMP and PDM supplies for manufacturing campaigns and GLP studies.

3.    Work with Quality departments (QC and QA) to maintain Manufacturing project goals and timelines.

4.    Responsible for set-up of Production suites as per IRISYS LLC SOPs.

5.    Perform various editorial duties; writes, reviews and edits SOP’s, Batch records and Material specifications.

6.    Create and Execute Qualification Protocols for new equipment at IRISYS LLC.

7.    Sets-up and operates various scientific apparatus, such as centrifuges, mixers, lyophilizers, incubators, homogenizers, tablet press, capsule filling machine.

8.    Perform and analyze data generated by analytical methods such as HPLC and Particle Size analyzer.

9.    Assist Scientists/Group Leaders with research projects.

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.

KNOWLEDGE, SKILLS AND/OR ABILITIES:

Familiarity with cGMP/FDA regulations.

Knowledge of laboratory procedures, of the use and preparation of solution, chemicals, and reagents.

Verbal and written communication skills.

Ability to follow oral and written instructions, to tend to details, to maintain records and inventory.

COMPETENCIES:

o   Responsibility/Ownership – the individual takes ownership of their assigned system or process and is constantly trying to improve it.

o   Problem solving—the individual identifies and resolves problems in a timely manner and gathers and analyzes information skillfully – including researching the internet.

o   Interpersonal Skills—the individual maintains confidentiality, remains open to others’ ideas and exhibits willingness to try new things. Respects co-workers.

o   Oral communication—the individual speaks clearly and persuasively in positive or negative situations.

o   Written Communication—the individual edits work for spelling and grammar, presents numerical data effectively and can read and interpret written information.

o   Planning/organizing—the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans.

o   Quality control—the individual demonstrates accuracy and thoroughness and monitors own work to ensure quality.

o   Quality assurance—the individual demonstrates competency by following all related SOP’s and immediately disclosing any discrepancies.

o   Adaptability—the individual adapts to changes in the work environment, manages competing demands and can deal with frequent change, delays or unexpected events.

o   Dependability—the individual is consistently at work and on time, follows instructions, responds to management direction and solicits feedback to improve performance.

o   Enthusiasm—the individual actively promotes and personally projects a positive attitude and a willingness to learn and go the extra mile when appropriate.

EXPERIENCE:

2+ years in the Pharmaceutical or Health science sector.

Experience with cGMP manufacturing is highly preferred.

Experience with or some knowledge of pharmaceutical Research, Development and Manufacturing unit processes (e.g., powder granulations, powder blending, tablet compression, encapsulation, aseptic mix and fill procedures, microencapsulation, etc.) is desirable.

EDUCATION:

A qualified candidate for the position must have at a minimum bachelor’s degree in Chemistry, Biochemistry, Physical Chemistry or other related field.

IRISYS, LLC is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. IRISYS does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.