Drug Product Manufacturing Scientist

Porton Pharma Solutions Ltd. is a leading global provider of comprehensive process R&D and manufacturing services to the pharmaceutical industry. We specialize in offering end-to-end solutions for small molecule APIs, dosage forms, and biologics. With a focus on innovation and customer satisfaction, we are committed to delivering high-quality products and services that meet the industry’s evolving needs. Our experienced team of experts works tirelessly to ensure every project is completed on time, within budget, and to the highest possible standards. Whether you need support with drug development, manufacturing, or regulatory compliance, Porton Pharma Solutions Ltd. has the expertise and capabilities to help you achieve your goals.

J-STAR Research, Inc. is a subsidiary of Porton that specializes in providing contract chemistry services to the biopharmaceutical and biotechnology industry. Our primary focus is resolving intricate chemistry problems relating to Active Pharmaceutical Ingredients and Intermediates in the preclinical and clinical development phases. We are adept in synthetic chemistry and process research services, which include Process Chemistry, Quality Control, Good Manufacturing Practice, Quality Assurance, Crystallization Research and Development, Solid Form and Polymorph Screening, Catalysis Screening and Enabling Technology, High Potent Compound Handling (HPAPI), Impurity Isolation and Structural Elucidation, and Preformulation and Formulation Research and Development.

We are seeking an experienced and highly motivated Drug Product Manufacturing Scientist to lead and support the manufacturing of pharmaceutical products in our organization. This critical role will involve the development, optimization, and execution of manufacturing processes while ensuring compliance with regulatory guidelines and maintaining the highest standards of product quality.

Position Title: Drug Product Manufacturing Scientist

Location: Cranbury, NJ

Direct Report: Director, Drug Product Development

Responsibilities:

• Hands-on experience working on equipment used for wet/dry granulation, FBD, tablet press, coater, automated capsule filler, spray dryer, hot melt extruder (HME) & others.
• Experience in scaling up products from lab scale to GMP scale for production & release of clinical trial material.
• Prepare, and review protocols, batch manufacturing records, SOPs
• Assist in GMP lab suite check out, clean out and check in processes.
• Responsible for documenting all batch manufacturing data generated as per GMP regulations.
• Good understanding of ICH, cGMP and regulatory requirements
• Work closely with QA, QC, Maintenance & other groups and maintain GMP production facility for compliance.
• Become proficient in all non-GMP and GMP SOPs
• Assist in the evaluation of production/processing equipment or fixtures for purchase and gathers data relating to their ability to meet organizational needs.
• Present the project technical findings to senior management and cross-functional team within the company and/or to the company’s clients.
• Assist in overall upkeep, maintenance, organization and housekeeping of GMP suites.
• Assist in work to trouble-shoot, maintain, repair, purchase, replace and install drug product manufacturing related equipment and services.
• Perform all job responsibilities with an uncompromising adherence to appropriate PPE utilization, safety and professionalism.
• Complete, understand and acknowledge all J-Star assigned and required training by due dates.
• Follow all company, site and laboratory Environmental, Health and Safety (EHS)-related protocols, processes, guidelines and SOPs.   Actively participate in EHS discussions with peers and management for continuous improvement of EHS practices.
• Perform other job-related duties and ad hoc facility-related projects as assigned by manager.

Requirements:

• Degree in Pharmaceutics, Chemical Engineering, or allied disciplines, Ph.D. with 2 years or MS with 4 years or BS with 5 years of industry experience in GMP drug product manufacturing of OSDs preferred.
• Familiar with the DP manufacturing facility and equipment qualification, maintenance, and cleaning.
• Previous experience working in a CDMO preferred.
• Ability to prepare, review and execute GMP documents.
• Extensive knowledge of USP, ICH, FDA, 21 CFR and other guidance documents
• Ability to interact in an effective and appropriate manner with diverse population sets.
• Ability to perform the physical requirements of the position. Must be able to walk, stand, crawl, stoop, crouch, bend or reach above and below shoulders height frequently. This job requires twisting and turning of the body and the use of both hands
• Excellent communications skills (verbal, written, and presentation skills). Must be organized and detailed-oriented.
• Must be a self-starter, self-motivated.
• Ability to prioritize & manage multiple projects simultaneously.
• Proficient in Microsoft Office and other job-related software and applications.

How to Apply:

• Applicants must be able to work legally in the U.S.
• Email resume to resumes@jstar-research.com.  Include the job title of the position you are applying for in the subject line.