This job description contains the fundamental responsibilities and priorities of the job. Furthermore, Particle Sciences is committed to cross training and team effort to accomplish business goals.
Every job, regardless of experience level or status requires regular attendance and punctuality. You are expected to act in a courteous and professional manner, and to comply with company, safety, and regulatory policies and procedures. Particle Sciences evaluates performance against the job description, tasks, goals, and various other factors, including accuracy, quality, creativity, customer focus, productivity and teamwork. Please note, the order of duties and responsibilities are not necessarily listed in the order of importance.
Essential Duties and Responsibilities
Responsibilities include, but are not limited to:
Execution of client projects involving planning and application of methodologies to address pre-formulation, formulation development and physical characterization
Expertise in a wide range of formulation processes, techniques and equipment
Experience in production of pre-clinical and clinical trial materials including necessary documentation required, ability to interface with Quality Assurance and Manufacturing groups
Scale-up and technology transfer to client companies
Interfacing with Analytical Services for testing of excipient compatibility, raw material qualification, and analysis of drug substance and drug product stability
Mentoring junior formulators on to equipment, processes, techniques and procedures
Working within a regulated environment following cGMP and SOP protocols
Writing client reports and developing SOPs, and other GMP documentation
Knowledge, Skills and Abilities
BS/MS/PhD degree in a scientific field
2 to 15 years of related experience in pharmaceutical industry, preferably including design, formulation and all phases of product development from inception to scale-up, or equivalent combination of education and experience with knowledge of current Good Manufacturing Practices (cGMP)
Experience with sterile product is a must
Experience with multiple dosage forms (solids, solutions, suspensions, long-acting formulations, including sterile and non-sterile) is desired
Experience with complex formulation technologies (nanoparticles, microparticles, lyophilization, sterile and aseptic) is desired
Strong physiochemical understanding of formulation components and interactions
Experience in physical characterization techniques, such as particle-size distribution measurement and optical microscopy
Proficient with common PC based applications and specifically in the use of MS Office
Knowledge of laboratory safety precautions and protocols for safe handling and the disposal of hazardous agents/reagents, chemicals and materials
Organization, communication and analytical skills
Ability to understand and effectively communicate technical and business information, both oral and written to others, including co-workers, supervisors, subordinates, clients, and vendors
Intermediate mathematical skills, including algebraic functions, statistics (mean, median, standard deviation, variance, probability), basic geometry (area, volume calculations), and scientific calculators
Ability to define problems, collect data, establish facts, and draw valid conclusions
Ability to work varied and extended hours/days, as business dictates
Qualification Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential job functions.
Physical Demands:
Regularly lift/carry/move up to 10 pounds, and occasionally lift/carry/move up to 50 pounds
May require standing for extended periods of time
This position requires the use of respirators.
Employees must pass the medical evaluation and fit test to be eligible for respirator use.
Proper fit testing requires the employees
Agno Pharma/Particle Sciences is an equal opportunity employer. We are committed to providing an environment where every employee can be the best they can be, no matter their race, color, religion, sex, national origin, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic.
Job Type: Full-time
Pay: From $1.00 per year
Benefits:
401(k)
401(k) matching
Dental insurance
Health insurance
Health savings account
Life insurance
Paid time off
Tuition reimbursement
Vision insurance
Schedule:
8 hour shift
Ability to Relocate:
Bethlehem, PA 18017: Relocate before starting work (Required)
Work Location: In person
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