Technical Services/Pharmaceutical Technology Scientist

Technical Services/Pharmaceutical Technology Scientist 4701 International Blvd, Wilson, NC 27893, USA Job Description Knoa Pharma is a public health-driven pharmaceutical company dedicated to addressing the opioid crisis. Our focus is on expanding access to lifesaving overdose reversal medicines and affordable treatments for opioid use disorder. Job Summary: Primarily responsible for transfer and validation of new products/processes into production, scale‑up/manufacturing development, product transfer, and optimization. Objectives include troubleshooting and reformulation of problem products, providing technical support to production Quality investigations, executing validation protocols, evaluating new production equipment, and assessing raw material sources. Primary Responsibilities Coordinate scale‑up batches of new products and processes, including batch record preparation, scheduling, raw material acquisition, and supervising batch manufacture. Identify potential product/process improvements of existing commercial dosage forms and present proposals for optimization after management approval. Develop new product/process activities and present proposals to optimize formula and product flow. Provide technical assistance to Production to solve shop‑floor problems, including troubleshooting active products and rework procedures for failed batches. Evaluate and qualify alternate sources of raw materials. Maintain compliance with Controlled Substance documentation and accountability procedures. Coordinate development and preparation of protocols for process/product validation studies, including cleaning and equipment validation. Prepare validation reports, with data analysis, conclusions, and recommendations. Coordinate execution of validation studies with production scheduling, reviewing protocols developed by others. Perform other related assignments and duties as required. Education and Experience BS degree in Chemistry, Biology or Engineering with a minimum of 5‑7 years of experience in Pharmaceutical Product Development and/or Process Development; Master’s degree with 4 years of experience. Necessary Knowledge, Skills, and Abilities Advanced knowledge of process development methodologies and current validation concepts, with a strong understanding of cGMP requirements and FDA/DEA regulations. Expertise in operating and overseeing pharmaceutical production equipment, including high‑shear granulators, fluid bed processors, solution preparation systems, weighing and dispensing systems, milling and blending equipment, tablet compression machines, and encapsulators. Comprehensive knowledge of pharmaceutical unit operations for solid oral dosage forms, with proven ability to apply scientific judgment during process development. Ability to develop data‑driven solutions to optimize formulations and manufacturing processes. Experience coordinating and executing process scale‑up activities with customized technical approaches. Strong capability in protocol development, selecting appropriate study designs to demonstrate process consistency and product acceptability. Proficient in preparing technical reports, including data analysis, interpretation, and documentation compliance with cGMPs, FDA regulations, and clinical requirements. Competence in investigating and documenting process deviations, discrepancies, and variations. Periodically encounter unexpected production problems such as: Equipment changes/modifications Process control system disruptions MES (SAP) system disruptions Supervisory Responsibilities This position has no direct reports. Physical and Environmental Perform job functions requiring sitting, stooping, balancing, kneeling, crouching, twisting, or reaching. Operate office devices such as computer, telephone, copier, fax, scanners. Lift and maneuver equipment and materials up to 20 pounds. Take samples and perform cleaning/assembly-disassembly of equipment weighing up to 20 pounds. Detect product defects such as discoloration or particulate matter at close range. Work a 10.5‑hour per day / 4‑day work week. Additional Information Relocation is not offered for this position. The Company does not sponsor any U.S. work authorization. Applicants must have unrestricted authorization to work or participate in an internship or training program. Equal Employment Opportunity We are an Equal Opportunity Employer. Qualified applicants will receive consideration regardless of race, sex or gender, national origin, citizenship status, religion, color, age, creed, sexual orientation, marital status, gender identity, protected medical condition, genetic information, disability, veteran status, or any other characteristic protected by law. For more information about your rights under Equal Employment Opportunity, visit the relevant state or federal resources. #J-18808-Ljbffr