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Formulation Development Specialist
2 meses atrás
Responsibilities:
* 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
Requirements:
* 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
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 to wear a respirator and perform a series of tasks while wearing it.
We are an equal opportunity employer and 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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