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

Senior Manager/Director, Regulatory- Full Time (Remote Optional)

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 is entering human clinical studies.

This Senior Manager position will provide tactical and strategic leadership on complex projects within the Regulatory Affairs Chemistry, Manufacturing, and Controls organization by actively contributing to the development and implementation of global CMC regulatory strategies throughout the lifecycle of pharmaceuticals and drug-device combination products. Our company has a dynamic portfolio consisting of both clinical and preclinical products in oncology, hematology, and cancer supportive care.

The organization management works on a virtual model, with site management of a physical location setup as an FDA-registered GMP analytical laboratory and development facility in Paramus, NJ. The team is highly experienced and ambitious. We are looking for team members who want to make an impact like never before. The products you help us develop will make people’s lives better. If you desire a stimulating fast-paced environment, working with intelligent people who are making an impact in cancer, Starton is a rapidly expanding opportunity and we would love to meet you!

Essential Duties and Responsibilities:

Responsibilities:

  • Function as regulatory affairs and CMC lead
  • Drive global technical regulatory strategy development and implementation for multiple complex products and programs.
  • Interact with manufacturing and quality groups, regulatory agencies, partner organizations, regarding CMC issues
  • Identify related risks and develop and implement risk mitigations, while anticipating regulatory responses and preventing downstream challenges.
  • Collaboratively interact with regulators and internal and external stakeholders regarding complex, high-visibility, and high-risk projects.
  • Stay abreast of, interpret, and communicate existing and/or proposed government regulations, registration requirements to Operations, Business, and R&D disciplines and apply these changes as necessary to facilitate Starton’s business plans and long-term goals.
  • Represent Starton by acting as a primary contact with regulatory authorities, including in the planning and leadership of complex health authority interactions, and regarding the authoring, review, and submission of complex CMC/Quality supplements and variations.

Required Qualifications

  • US citizen or able to work in the U.S.
  • 5 years of GXP regulatory experience
  • Pharmaceutical development and lifecycle management experience.
  • Robust critical thinking, writing, communication, presentation, and project management skills.
  • Ability to interpret and apply global CMC/Quality drug and medical device regulations and guidance documents to supported programs, products, and cGMP changes to ensure fully compliant submissions, regulatory dossiers, and project plans.
  • Capacity to quickly and accurately define technical data and information requirements necessary to obtain first-pass global regulatory CMC approvals regarding supported submissions and project plans.
  • Ability to independently lead the preparation, review, and submission of high-quality, globally complex CMC supplements and variations, and to document submissions and follow-up appropriately.

Preferred Skills/Qualifications:

  • Strong basis of scientific knowledge in oncology/hematology
  • Expert knowledge of regulations and experience with interpretation and application
  • Strong negotiation skills and significant experience in interacting with regulatory authorities
  • Risk identification and collaborative problem-solving skills
  • Established relationships with regulatory authorities
  • Solid knowledge of pharmaceutical science and quality assurance
  • The candidate must be proficient in English; additional language skills are a plus

Travel: Less than 10% but need passport

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.

At Starton, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex, physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

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.

Quality Assurance Associate/Manager- 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 is entering human clinical studies.

Starton is currently seeking a Quality Assurance Associate. The ideal candidate is enthusiastic, self-motivated and a self-starter.  Under direct and minimal direction, the individual will be able to monitor, update, and manage the Quality Management Systems for the Paramus facility.  Maintain the Quality Assurance and Quality Control for processes and procedures in accordance with the guidelines and regulations set forth by FDA and other regulatory agencies and authorities.  Provide quality input, oversight, and assistance for the efficient functioning of the analytical and manufacturing operations of a GMP analytical laboratory, warehouse, and GMP Pilot Plant for production and control of clinical trial materials.  Ensure compliance with GMP documentation and training.

The organization management works on a virtual model, with site management of a physical location setup as an FDA-registered GMP analytical laboratory and development facility in Paramus, NJ.  The candidate is expected to have hands-on experience in all aspects of a pharmaceutical development and manufacturing organization to include analytical, research and development, formulation, GLP, and cGMP manufacturing of clinical trial materials.  If you desire a stimulating fast-paced environment, working with intelligent people who are making an impact in cancer, Starton is a rapidly expanding opportunity and we would love to meet you!

Essential Functions

  • Knowledge of Quality Control and Quality Assurance process and procedures in the pharmaceutical industry.
  • Knowledge of current FDA, DEA, ICH, State of NJ, and OSHA guidelines and regulations.
  • Assist with Monitoring, Updating, Managing, and Maintenance of the Quality Management System to include but not limited to Document Control, Record Control, Filing Management, Investigations, Deviations, Change Controls, OOS/OOT, Personnel Training, CAPAs, Internal and External Audits, Vendor Management in order to comply with GMP and regulatory requirements for Phase I GMP.
  • Establish, Implement, Manage and Maintain procedures and documents to include but not limited to SOPs, STPs, Specifications, Investigations, Certificates of Analysis, Batch Records, Validation Protocols, Analytical Methods and Validation, Stability, Samples, and other documents as necessary.
  • Write, Review, Approve and Release authority on documentation in the quality management system.
  • Prepare, issue, and release procedures and documents applicable to the different areas of Quality Control, Quality Assurance, Analytical, Manufacturing, Inventory Control, Cleaning and Safety.
  • Oversee compliance with the established procedures.
  • Identify QMS gaps with problem-solving anticipation for resolution.
  • Contributes to all aspects of the day-to-day laboratory operations and creating and implementing laboratory operations systems and procedures, to assure the QC laboratory complies with all regulatory requirements to include stability, warehouse, validation, and other aspects of pharmaceutical analytical laboratory and manufacturing as deemed necessary.
  • Maintain rigor and high quality of execution and documentation complying with all regulations.
  • Conduct work in accordance with guidelines and requirements established by FDA Good Manufacturing Practices, Code of Federal Regulations, and other regulatory agencies.
  • Communicate clearly and concisely, both verbally and in the form of written reports, including drafting and review of protocols, SOPs, batch records, and regulatory documentation to support clinical development.
  • Identify and troubleshoot technical problems with equipment and analytical procedure.
  • Draft and execute analytical procedure qualification/validation protocols and write reports.
  • Design and conduct studies to optimize and improve the robustness of analytical procedures.
  • Assist in project management to establish and maintain timelines.

Qualifications:

  • BS or MS 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 experience working in cGMP environment.
  • Must understand the difference between development and GMP quality requirements.
  • Must have demonstrated experience with Good Documentation Practices.
  • Excellent oral and written communication, computer, scientific and organizational skills.
  • Ability to work independently and as part of a team, self- motivated, adaptable and with positive attitude.
  • Ability to learn new techniques performs multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.

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.

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.