Technical Services/Pharmaceutical Technology Scientist

Join Knoa Pharma

Knoa Pharma is a public health-driven pharmaceutical company dedicated to addressing the opioid crisis. Our focus is onexpanding access to lifesaving overdose reversal medicines and affordable treatments for opioid use disorder.Ownedbya not-for-profit foundation,everything we do is centeredonimproving public health,saving lives,supportingrecovery,and bringing forward medicines that make a meaningful difference.

Knoa Pharma has a robust generics and branded portfolio of medicines in development to address unmet medical needs, and it supports public health initiatives to address the opioid crisis. Its public health-minded purpose enables the company to expand access to lifesaving opioid overdose reversal medicines and affordable treatments for opioid use disorder - at no profit.

Job Summary

Primarily responsible for transfer and validation of new products/ processes into production, scale-up/manufacturing development, product transfer, and optimization. The major objective is to ensure successful new product transfer to production and proper training of production personnel in any new process and/or equipment. Key objectives include troubleshooting and reformulation of problem products, providing technical expertise and support to production Quality investigations. Other key objectives include generation, execution, and reporting of products, cleaning, and equipment validation protocols. Additional objectives include new production equipment selection and evaluation, rework evaluation of rejected batches and new/existing raw material evaluation.

Primary Responsibilities

• Coordinate the scale-up batches of new products and processes including such tasks as batch record preparation, scheduling, raw material acquisition, supervising batch manufacture, etc.
• Identify potential product/process improvements of existing commercial dosage forms. Present proposals to optimize formula and product flow and implement changes after management approval.
• Responsible for development of potential product/process activities for new products. Will present proposals to optimize formula and product flow.
• Provide technical assistance to Production, as needed, to solve problems as they occur on the shop floor. This responsibility includes both troubleshooting of active products on the shop floor and potential rework procedures for failed batches.
• Responsible for new equipment evaluation. Will interface with engineering and equipment manufacturers to ensure proper installation and operation of the new equipment. Will be responsible for coordination of all activities to transfer new equipment to production, including training as required for both supervisors and operators.
• Evaluate and qualify alternate sources of raw materials.
• Maintain compliance with Controlled substance documentation and accountability procedures while maintaining high level to diversion and theft possibilities.
• Coordinate, develop and prepare protocols for process / product validation studies, including cleaning and equipment validation.
• Prepare validation reports, including data analysis, conclusions and recommendations.
• Coordinate the execution of validation studies with production scheduling. This may also include review and execution of protocols developed by other individuals.
• Perform other related assignments and duties as required and assigned.

Education and Experience

BS degree in Chemistry, Biology or Engineering with a minimum of 5-7 years' experience in the fields of Pharmaceutical Product Development and/or Process Development; Master's degree and 4 years of experience.

Necessary Knowledge, Skills, and Abilities

• Advanced knowledge of process development methodologies, including current validation concepts, with a strong working understanding of cGMP requirements and FDA and DEA regulations.
• Demonstrated expertise in the operation and oversight of pharmaceutical production equipment, including highshear granulators, fluid bed processors, solution preparation systems, weighing and dispensing systems, milling and blending equipment, tablet compression machines, and encapsulators. Ability to direct batch manufacturing activities, ensure compliance with SOPs and safety standards, and provide handson guidance to production operators.
• Comprehensive knowledge of pharmaceutical unit operations, particularly as they relate to solid oral dosage forms. Proven capability to apply sound scientific judgment and make timely decisions during process development, design of experiments (DOE), and batch manufacturing activities.
• Demonstrated ability to develop original, datadriven solutions to optimize formulations and manufacturing processes.
• Proven experience coordinating and executing process scaleup activities, recognizing that scaleup strategies vary by product and require customized technical and operational approaches.
• Strong capability in protocol development, including selection of appropriate study designs to demonstrate process consistency and product acceptability. This requires independent research, technical originality, crossfunctional collaboration, effective use of internal resources, and strong timemanagement skills.
• Proficient in the preparation of technical reports, including analysis and interpretation of data against specifications and acceptance criteria. All documentation must comply with cGMPs, FDA regulations, clinical requirements, and current validation practices. Responsible for investigating, documenting, and justifying all process deviations, discrepancies, and variations

• Periodically, the Scientist may encounter unexpected production problems as well as process deviations during the execution of studies. Examples of problems typically experienced are:

o Equipment changes/modifications

o Equipment malfunction/breakage

o Process control system disruptions

o MES (SAP) system disruptions

Supervisory Responsibilities (if Applicable)

This position has no direct reports.

Physical and Environmental

• Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching. While sitting for an extended period of time on a routine basis, incumbent may use the following equipment: Personal computer, telephone/ other voice communication devices, copier, fax, scanners, or other specialized equipment used in an office setting.

• Lift and maneuver equipment and materials weighing up to 20 pounds.
• Take samples which may require stretching, bending, or twisting to remove product from the equipment and/or drums.

• Perform cleaning and assembly/disassembly on equipment which may require pulling, pushing, or twisting to remove equipment shields, parts and panels. Equipment and parts could weigh up to 20 pounds.
• Must possess the ability to detect, recognize, and accurately distinguish defects such as discoloration, particulate matter, and other visual anomalies at close range (18 inches) with or without a reasonable accommodation (magnifiers, prescription glasses) that may affect product quality or patient safety.
• Ability to work a 10.5 hour per day/4-day work week.

Additional Information

Relocation is not offered for this position.

The Company a does not sponsor or facilitate any U.S. work or training authorization for this position. All applicants must have unrestricted and independent authorization to work or participate in an internship or training program at the Company.

Minimum required education, experience, knowledge, skills and abilities are included in the posting. The position will be filled at the level commensurate with the successful candidate's education, experience, knowledge, skills, and abilities.

The job description is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions. Additionally, the company may revise the job description at any time.

We are an Equal Opportunity Employer. Qualified applicants will receive consideration without regard to: actual or perceived race, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), national origin, ancestry, citizenship status, religion, color, age, creed, sexual orientation, marital status, gender identity or gender expression (including transgender status), protected medical condition as defined by applicable state or local law, genetic information, physical or mental disability, veteran status and military service, or any other characteristic protected by local, state, or federal laws and ordinance.

For more information about your rights under Equal Employment Opportunity, visit:

• EEOC Know Your Rights
• USERRA Rights
• Family and Medical Leave Act (FMLA)
• Employee Polygraph Protection Act (EPPA)
• E-Verify (English and Spanish)
• Right to Work (English and Spanish)

We strive to make our Career opportunities website accessible to all users. If you need an accommodation to participate in the application or hiring process, please email the Knoa Pharma LLC Talent Acquisition team at View email address on click.appcast.io . This email is not for general employment inquiries or vendors; rather it is strictly for applicants who require assistance.

The Company does not seek or accept unsolicited resumes or CVs from recruitment agencies. We are not responsible for any fees, commission, or any type of payment related to unsolicited resumes or CVs except as required in a written agreement between the Company and the recruitment agency or party requesting payment of a fee.

Under certain state law, we may be required to provide a reasonable estimate of the salary range for the jobs covered by this description. Actual salary determinations will take into account factors such as work location, prior education or training and experience, job related knowledge, and demonstrated skills aligned with the Company's internal leveling guidelines and benchmarks. Resumes may be considered in the order they are received.