Principal Scientist, Technical Project Leader

SUMMARY/OBJECTIVE:

The Technical Project Leader (TPL) is responsible for all technical activities associated with assigned projects. This includes generating protocols, master batch records, and reports. The TPL collaborates closely with the project manager, operations leadership, and laboratory leadership to plan and execute all project activities. Externally, the TPL partners with customers to ensure all scientific aspects of the project are addressed, including proposing new scientific work, interpreting experimental data, and presenting results. This role requires strong awareness of all scientific project activities and proactive management of them.

 Key Responsibilities

• Design experiments to support formulation and process development, and author the associated protocols.
• Manage experimental activities, with the potential to assist in hands-on execution.
• Receive and analyze analytical, physicochemical, and manufacturing data using statistical tools, mathematical models, and spreadsheets.

Data Analysis Skills

• Excel, including pivot tables
• Graphing (scatter plots, line, bar, etc.)
• Effective data presentation through tables and graphs
• DOE (design of experiments) and factorial studies
• Capability analysis
• Statistical process control
• Risk & Quality Tools
• FMEAs
• Quality by Design
• Root Cause Analysis (5 Whys, Fishbone, 6Ms)

Additional Qualifications

• Working knowledge of basic analytical methods to properly interpret data
• Strong presentation skills for discussing experiments and data with customers
• Strong protocol and report writing skills (writing sample preferred)
• Excellent organization and data-interpretation abilities
• Ability to work in both GMP and R&D settings, including operating effectively within R&D activities conducted in        a GMP environment
• Ability to collaborate with a GMP production group
• Understanding of the appropriate level of quality required for different situations
• Ability to read and author SOPs and Work Instructions when needed

Desired Specializations (at least one)

• Process Development
• Spray Drying (formulation and/or process)
• Oral Solid Dosage Formulation
• Powder Filling/Handling
• Other relevant pharmaceutical, scientific, or engineering expertise
• Experience with purchasing, commissioning, and qualifying equipment is a plus.

 QUALIFICATIONS AND EXPERIENCE:

PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field + 3–5 years of relevant industry experience

OR

Master’s degree (MS) in a scientific or engineering discipline + 5–8 years of relevant industry experience

 SUPERVISORY RESPONSIBILITIES:

None

 SCHEDULE:

On-Site 4 days a week and 1 day working from home

 SALARY:

$135,000 to $175,000

WORK ENVIRONMENT:

Standard office environment

 PHYSICAL DEMANDS:

Office Environment (standing and sitting) requiring minimal physical exertion.

 TRAVEL:

Domestic travel will be required less than 5% of the time.

The job demands described here are representative of those that must be met by an employee to successfully perform the functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job.  It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations and for establishing performance standards.  The percentage of time spent performing the various job duties is not absolute.  The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.

 EXPERIC is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.