At Starton Therapeutics, we are working together to develop innovative therapies that transform standard of care therapeutics. Our mission is to improve outcomes and quality of life for patients.

Current openings:

Starton Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

To apply for a position, please click on the “Submit Application” button or send your resume and cover letter to careers@startontx.com

Pharmaceutical Technician – Full Time

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. This individual shall be enthusiastic, self-motivated and a self-starter.  The individual will be responsible for performing, under direct supervision, analytical methods development, chemical and physical assays in support of pharmaceutical development projects. The individual will support quality assurance, analytical laboratory, and GMP pilot plant.  The individual will assist with the stability program and validation activities.  The individual will assist in the manufacturing of clinical trial material and process development of drug products. The individual will assist in project management.

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.

Essential Functions

  • 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.

Qualifications:

  • 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.

Compensation

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.

How to Apply

  • To apply for a position, please click on the “Submit Application” button or send your resume and cover letter to careers@startontx.com
  • Accepted file types: pdf, doc, docx, rtf.
  • Accepted file types: pdf, doc, docx, rtf.

Director of Clinical Operations – Remote

Starton is currently seeking a Director of Clinical Operations. The selected candidate will be responsible for leading and directing the cross-functional study team in managing multiple, complex clinical studies in oncology. The Director of Clinical Operations is expected to manage the Clinical Operations function in its entirety within Starton while simultaneously managing all aspects of clinical studies from protocol concept to clinical study reporting and disclosure.

The entire organization works on a virtual model, with a development laboratory in New Jersey. The Team is highly experienced.

Essential Duties and Responsibilities:

  • Directs study operational plan and CRO activities, including project timelines, quality of deliverables and budget(s) throughout clinical trials.
  • Selects and oversees study vendors for assigned studies.
  • Maintains frequent and meaningful contact with contractors and CROs to assess performance and provide guidance as needed.
  • Reviews and refines clinical operational plans including the study monitoring plan and other plans as needed.
  • Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials.
  • Contributes to relevant study documentation including clinical protocols, statistical analysis plan, clinical study reports as well as operational plans (CMP, DMP).
  • Participates in developing and managing study timelines (including recruitment).
  • Participates in the selection of investigational sites with input from Clinical/Medical functions and vendors.
  • Participates in medical issue resolution.
  • Proactively identifies project risks and creates mitigation strategies in collaboration with Clinical/Medical function.
  • Participates in study data review and other review activities.
  • Oversees clinical trial sites’ adherence to pertinent regulations and SOP’s through review of monitoring reports, CQA-GCP audit report, communications with investigators, study site personnel, CRAs, and other CRO resources.
  • Leads ongoing review of data to ensure GCP.
  • Oversees the submission of trial-related and essential documents to the Trial Master File.
  • Identifies and provides solutions to clinical trial issues and/or risks.
  • Represents Clinical Operations in cross-functional initiatives.
  • Provides or facilitates training to clinical study teams on assigned protocol specific topics.
  • Work closely with other teams in the organization, e.g. quality, regulatory, biostats, etc.
  • Provide input into non-project related activities and development of department processes and standard operating procedures.
  • Recruit, manage and mentor clinical operations staff.

Qualifications:

  • BS in nursing, pharmacy, medicine, life science, or related field (or equivalent experience).
  • Minimum of 10 years of clinical research experience, at least 5 of which are as a Clinical Operations Director and/or a Project Manager for clinical studies at
    CRO/pharmaceutical/biotech organizations.

Preferred Requirements:

  • Master’s Degree in nursing, Doctor of Pharmacy, Medical degree (license in US not necessary), doctorate level in life science, or related field (or equivalent experience).
  • 10+ years of clinical research experience, at least 5 of which are as a Clinical Operations Director and/or a Project Manager for clinical studies at pharmaceutical/biotech organizations.
  • Experience in managing nonclinical programs and assisting manufacturing staff for translation into the clinic.
  • Extensive experience in oncology (particularly hematologic malignancies), and immuno-oncology preferred

Travel:

  • Travel up to 20% of the time, within U.S.
  • US citizen or able to work in the U.S.

 

Compensation:

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.

How to Apply

  • To apply for a position, please click on the “Submit Application” button or send your resume and cover letter to careers@startontx.com
  • Accepted file types: pdf, doc, docx, rtf.
  • Accepted file types: pdf, doc, docx, rtf.