Careers

Home
Careers

Open Positions

We are always looking for motivated, talented individuals who share our values to join The Kenox Team. If you are interested in a career at Kenox Pharmaceuticals, Inc., please contact us at hr@kenoxpharma.us.

Current Openings

Quality Assurance Specialist
New Jersey 5 Years Full-Time

Job Description:

Kenox Pharmaceuticals Inc. is a specialty CDMO, based on Princeton NJ, focused on aerosol-based drug-delivery products for ophthalmic, nasal, oral, and inhalation applications. We have been partnered with pharmaceutical and biotechnology companies to bring life-changing inhaled and intranasal therapies to the clinic faster and more efficiently.

We're excited to offer Quality Assurance Specialist to join our rapidly expanding team. The Quality Assurance Specialist will lead QA CMC oversight for drug products including small molecules, peptides, biologics, and combination product programs from pre-clinical stage through Phase 2, ensuring phase-appropriate GMP compliance across manufacturing development. The position will be critical to shaping Kenox’s quality strategy and supporting regulatory readiness for our broad range of complex products in development.

Key Responsibilities
- Quality Management System (QMS): Develop, implement, and maintain a comprehensive QMS to ensure compliance with regulatory requirements and industry standards.
- Audits and Inspections: Conduct internal audits of manufacturing processes and facilities to verify compliance with Good Manufacturing Practices (GMP) and internal quality standards. Prepare for and participate in external regulatory inspections.
- Documentation Review: Review and approve essential documents such as batch production records, standard operating procedures (SOPs), and validation protocols to ensure accuracy and compliance.
- Product Release: Ensure that products are released for distribution only after they meet all required specifications and safety standards.
- Training and Development: Provide training to employees on quality-related topics, including GMP and the QMS, to ensure that all staff are knowledgeable about quality standards and practices.
- Deviation Management: Investigate and resolve quality-related issues, including conducting root cause analysis and implementing corrective and preventive actions (CAPAs).
- Continuous Improvement: Drive continuous improvement initiatives by identifying process inefficiencies and implementing best practices to enhance product quality and operational efficiency.
- Supplier Quality Assurance: Review and approve supplier contracts, conduct supplier audits, and ensure that raw materials meet quality standards.
- Stability Testing: Oversee stability testing of pharmaceutical products to determine proper storage conditions and shelf-life.
Education
- BS degree in Life Sciences, Chemistry, Engineering, or related discipline; advanced degree (MS, PhD, PharmD) strongly preferred
Experience & Proficiencies
- Minimum of 5 years of relevant Quality Assurance experience in the pharmaceutical industry
- In-depth knowledge of phase-appropriate quality systems, regulatory requirements (21 CFR Parts 210/211, 600s, 820, ICH, EU Annexes, ISO 13485/14971), and compliance expectations across clinical development.
- Proven expertise in root cause analysis, investigations, change control, and quality risk management.
- Experience developing OINDP pharmaceutical products preferred.
- Authorized to work in the United States
Please send your resume to hr@kenoxpharma.us
Apply Now
Senior and Principal Scientist - Nasal and Inhaled Product Development
New Jersey 3+ years Full-Time

Job Description:

Kenox Pharmaceuticals Inc. is an emerging specialty CDMO focused on aerosol-based drug-delivery products for ophthalmic, nasal, oral, and inhalation applications. We're excited to offer multiple opportunities for Senior or Principal Scientists to join our rapidly expanding team. These roles will be critical in supporting the preclinical and clinical development (Molecule to First-in-Human) of Orally Inhaled and Nasal Drug Products (OINDPs).

The ideal candidates will support pre-formulation, formulation, and process development for a variety of sterile and non-sterile nasal and inhaled formulations. This includes both liquid (solution or suspension) and dry powder approaches. You'll also be involved in the physical and chemical characterization of drug substances and drug products using a range of analytical tools.

Key Responsibilities:
- Lead the end-to-end development of OINDP products, including nasal sprays, soft mist inhalers, nebulizers, and DPI platforms. This includes driving successful pre-IND meetings, INDs, and NDA/ANDA filings through pre-formulation studies, analytical development, formulation and process development, and OINDP testing.
- Apply thorough knowledge and hands-on experience with nasal and inhalation product testing methods, instrumentation, and software, including Next Generation Impactor (NGI), Spray View, Malvern Spraytec, Laser Diffraction, and Spray Content Uniformity.
- Independently author, review, and approve method documents, protocols, product development reports, and technical reports/summaries.
- Ensure the generation of accurate, reliable data by following established procedures and practices for product development. This includes meticulously recording, tabulating, summarizing, and reporting results.
- Interpret and display data in a clear and concise manner, thoroughly and accurately documenting all developmental and testing work.
- Supervise and mentor junior-level scientists and technicians in the design and execution of various product development and testing activities.
- Ensure safe and effective laboratory operations and timely project delivery.
- Contribute to and develop SOPs and technical documents to support the IQ/OQ/PQ of equipment.
- Manage vendors (CMO/CROs) and provide technical support for successful scale-up.
- Interface with collaborators and key partners, including device companies, R&D leaders, CMC-Leaders, Regulatory Affairs, and QC/QA teams.
Qualifications:
- Minimum of a Bachelor's or Master's degree in Pharmaceutical Sciences or a related field.
- 3+ years of experience in drug-device combination products, with a strong preference for inhaled and intranasal product development and testing.
- Well-versed in early-stage (non-GMP) through IND-enabling and clinical (GMP) development.
- Thorough understanding of general laboratory procedures to reliably conduct analyses and operate lab instrumentation.
- Comprehensive understanding of ICH, FDA, and other regulatory expectations for method validation, transfer, and GMP testing.
- Must be able to interact effectively with peers and thrive in a fast-paced environment.
- Excellent communication, strong organizational, multitasking, and effective interpersonal skills are required.
Please send your resume to hr@kenoxpharma.us
Apply Now