The Principal Scientist will support the research and development and manufacturing programs of biotechnology clients. Demonstrates strong expertise in one or more of the following area; molecular biology, biochemistry, chemistry, protein chemistry, toxicology, and mass spectrometry. Supports analytical studies for peptides, proteins, carbohydrates, nucleic acids as well as small molecule drugs in solid dosage forms, parenteral, transdermal patches, liquids and APIs.
Maintains an expert knowledge and mastery of equipment, instrumentation, procedures and scientific methodologies necessary to perform complex research or projects. Provides complex problem solving and technical trouble-shooting assistance applying state-of-the-art scientific principles and innovative, efficient use of instrumentation and equipment. Extrapolates scientific trends and theory for presentation to management. Ability to efficiently organize work with little or no supervision. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Determines methods and procedures on new assignments. Will review own work and conduct peer review. Demonstrates expert knowledge of scientific principles.
Trains others in technical field and provides coaching and mentoring to new employees/staff. Assists in implementation of new methods and processes to solve problems. Prepares summaries of observations, capable of verbal and written presentations to peers. Documents proficiently in laboratory notebooks. Will assist in the maintenance and calibration of the laboratory equipment as needed.
Maintains a high level of professional expertise and a through familiarity with scientific literature. Participates in scientific conferences and contributes to scientific journals. Writes client communications, deviations, specifications and investigations. Interact with clients and participates in FDA and/or client audits.
Key Job Responsibilities:
Performs assigned tasks carefully and on schedule according to standard operating procedure with little or no supervison.
Will assist in maintenance and calibration of the laboratory equipment.
Writes SOPs, test procedures, specifications and summary reports.
Maintains working knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks. Act as technical resource for the company.
Analyzes information for technical correctness and accuracy.
Participates in company sponsored training and maintains current status of certifications.
Participates in national meetings, such as AAPS, as appropriate.
Provides technical training and leadership for subordinate technical positions.
Interacts with peers and outside departments and clients.
Maintains a safe, clean, and organized work environment free of safety hazards.
Suggests improvements for safety, work quality, and productivity.
Works the hours necessary to meet scheduling commitments; is punctual with low absenteeism.
Essential Job Requirements:
Ph.D. in Chemistry, Biochemistry, Physics, Molecular Biology, Toxicology, Pharmaceutical Science or related field is required, with 4 – 9+ years related experience. MS in Chemistry, Biochemistry, Physics, Molecular Biology, Toxicology, Pharmaceutical Science or related field with 10-15+ years experience.
Proficiency in Word and Excel.
Extensive knowledge of chemical and scientific calculations.
Extensive understanding of GLP/GMP Policies/Regulations.
Extensive Laboratory Skills (equipment usage, terminology, etc).
In depth knowledge one or more of the following: protein chemistry, chromatographic separations, electrophoresis, mass spectrometry, immunoassays, biological or cell based potency assays
Ability to work well in a team setting and to collaborate across working groups.
Ability to plan and schedule multiple tasks
Excellent verbal and written communication skills.
Supervisory skills preferred.
Supervision Received: General
Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Acts independently to determine methods and procedures on new assignments. May seek management direction for problems of diverse and/or complex scope.
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.
While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is occasionally required to walk; sit; climb or balance and stoop, kneel, crouch, or crawl. 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, color vision, peripheral vision, depth perception and ability to adjust focus.
Environment and Protective Equipment:
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 occasionally exposed to wet and/or humid conditions; moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.
LIMITATIONS AND DISCLAIMER
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position.
All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees.
This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. Job Description Position Title: Principal Scientist Job Family: Biotechnology
Requirements are representative of minimum levels of knowledge, skills, and/or abilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.