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
Job Type: Full-time
Pay: $80,000.00 - $160,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Education:
- Bachelor's (Preferred)
Ability to Relocate:
- Bethlehem, PA 18017: Relocate before starting work (Required)
Work Location: In person