Position: PHARMACEUTICAL TECHNICIAN, FULL TIME
Location: PARAMUS, NEW JERSEY
Starton Therapeutics, Inc., founded in 2017, is a clinical stage biotechnology company transforming approved drugs using a transdermal delivery technology. This technology uses an adhesive patch to deliver medicine through the skin. The delivery is a controlled, sustained release over multiple days. The company’s focus is to address hematology and oncology malignancies, initially chronic lymphocytic leukemia, and multiple myeloma. Its lead candidate, STAR-LLD, is entering human clinical studies.
Starton is currently seeking a Pharmaceutical Technician.
The organization works on a virtual model with a physical location setup as a FDA-registered GMP analytical laboratory and development facility in Paramus, NJ. The candidate is expected to have hands-on experience in analytical, formulation, and cGMP manufacturing of clinical trial materials. The position is located at the facility and the candidate is expected to be at the physical location with very limited ability for remote work.
- Provide technical support to company departments.
- To support the analytical laboratory, the individual will perform, under supervision, physical and chemical tests as per written procedure. The individual will have the opportunity to assist in ascertaining degradation profiles, solve scientific problems and develop and validate analytical methods for drug substances and drug products. Instrumentation to include but not limited to HPLC, GC, pH meter, viscometer, adhesive test equipment, FTIR, dissolution and other standard laboratory equipment. Assist in maintaining laboratory equipment and documentation.
- To support the research and development laboratory, the individual will perform formulation work, under supervision. Ability to learn and provide technical leadership for the analytical development. Assist in the management of the laboratory and facility. Develop and validate stability indicating assay procedures for pharmaceutical chemicals and finished dosage forms.
- Perform testing of samples as required to support product development, regulatory submissions and the commercial stability program. Perform laboratory work to support product or process troubleshooting, special investigations and product complaints with sufficient supervision. Assist in the general operation of the analytical laboratory and equipment.
- Perform laboratory work to support method validation or investigations. Assist performing validation of new equipment and the maintenance of the existing analytical equipment. The individual will participate in the writing of stability reports, product development reports and product specifications. Maintain accurate and complete laboratory records as required by company policy and Good Manufacturing Practices (cGMP) requirements.
- Assist and perform formulation work in the production, testing or preparation of drug products and samples.
- Assist in management of the GMP documentation system to include but not limited to Standard Operating Procedures (SOP), Standard Test Procedures (STP), batch records, specifications, and other GMP documentation to support process, functions, training and or equipment.
- Help to define, set, establish, and accomplish product development timelines in a team environment.
- Perform other duties as deemed necessary by the management.
- Design, develop, conduct and provide preliminary interpretation of study results with high level of independence.
- BS in the analytical, chemical, pharmaceutical or life sciences is required
- 3-10 years related experience and/or training; or equivalent combination of education and experience.
- Must have demonstrated thorough working knowledge of chemical analysis, including HPLC, preferably Agilent.
- Must have demonstrated experience working in cGMP environment.
- Must have demonstrated experience with Good Documentation Practices.
Starton will offer a competitive salary, generous bonus program and liberal PTO policy. The company also offers a comprehensive benefits package and pays a large portion of health insurance premiums.
Company equity in the form of stock options will also be offered.