Quality Control Chemist - Nucleus RadioPharma : Job Details

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The Quality Control (QC) Chemist plays a critical role in performing QC analytical testing and ensuring compliance with regulatory standards to support the production of radiopharmaceutical drug products. The QC Chemist will develop, validate, and execute QC analytical methods, provide technical expertise, and work collaboratively to lead and develop a highly effective QC team. This role involves routine testing, method validation, troubleshooting, and ensuring adherence to cGMP and regulatory guidelines for the successful release of radiopharmaceutical products.

Description

PRINCIPAL RESPONSIBILITIES:

* Supports the development and leads the execution of QC methods for radioactive drug products in a GxP environment, including radio-HPLC, TLC, GC, gamma spectroscopy, endotoxins, pH, etc.

* Supports the execution of laboratory equipment qualification, ensuring all instruments are properly validated and calibrated.

* Assists in supervision of the QC Chemistry team which includes mentoring, assigning tasks, setting performance goals, training, coaching, and offering performance and development management.

* Provides support and assistance for laboratory personnel in daily activities to fulfill client and GMP requirements.

* Performs trend analysis of QC analytical results.

* Assists in Out of Specification investigations.

* Responsible for training QC Technicians on cGMP guidelines 21 CFR 210, 211, 212,as applicable.

* Responsible for training QC Technicians in analytical and QC testing methods.

* Serves as Subject Matter Expert for Quality Control testing on site.

* Collaborate with other groups within the facility to understand goals and communicate changes throughout the organization.

* Provide input for strategic planning for new product lines.

* Work closely with QC Manager and scientific staff to evaluate technical feasibility of new products.

* Supports in maintaining QC budget and responsible for communicating QC laboratory staffing and budget needs.

* Assists in Writing, maintaining, and updating necessary Standard Operating Procedures (SOPs), Validation Protocols and Validation Report.

* Performs other duties as assigned.

QUALIFICATIONS & REQUIREMENTS:

* Bachelor's degree in chemistry or related area required; Master's degree in chemistry or related area preferred.

* Minimum of 5 years of experience in analytical chemistry, QC lab operations, and leadership in a regulated pharmaceutical or radiopharmaceutical environment.

* Experience working in facilities compliant with ICH Q7, GxPs, 21 CFR 211 and 21 CFR 212 and knowledge of regulations applicable to drugs and devices (21 CFR Parts 210/211, ICH and FDA guidances, etc.) and the ability to apply them based on the phase of the project (GLP, Phase I, PhaseII/III, etc.) required.

* Analytical instrument operation and maintenance (HPLC, GC, TLC, etc.) experience required.

* Review QC data for accuracy, completeness, and compliance with regulatory requirements.

* Ensures QC activities adhere to internal procedures, GMP, and regulatory requirements.

* Involvement in audits or regulatory inspections (internal/external) and addressing findings as necessary.

* Continuously evaluate and implement new analytical technologies and methods to improve QC efficiency.

* Knowledge of 21 CFR 212 and USP 823 regulatory requirements preferred.

* Radioactive material handling of gamma, beta and/or alpha emitters in radiological facilities (shielded glove boxes, hot cells etc.) experience preferred.

* Writing of technical documents (procedures, records, forms, experimental reports etc.) experience required.

* Advanced ability to effectively lead one or more projects with competing priorities to meet the demands of a fast-paced and dynamic work environment required.

* Adaptable to quickly changing priorities required.

* In-depth critical thinking skills to evaluate issues and identify a potential solution. Creatively addresses complex or new problems required.

* Advanced interpersonal skills, including but not limited to problem-solving, teamwork development, and leadership with other team members. Works well with others to achieve common goals required.

* Possess the ability to troubleshoot QC issues in a regulated radiopharmaceutical environment, involving cross-departmental communication.

* Strong attention to detail with the ability to maintain accuracy in laboratory analysis and documentation.

* Ability to work effectively both independently and within a team.

* Experience with method development and validation is a plus.

* Understanding of quality systems and regulatory expectations for analytical labs.

* Ability to foster an inclusive and cooperative work environment.

* Ability to work sitting and standing for extended periods, grasping/gripping, fine motor control with hands.

* Ability to lift / move, transport, position equipment and work items weighing up to 30 pounds across on a frequent basis.

This job description is a summary of the typical functions of the position, not necessarily an exhaustive or comprehensive list of all possible position responsibilities, tasks and duties. The company reserves the right to assign or reassign duties and responsibilities to this job at any time. This job does not constitute a written or implied contract of employment; employment remains at-will .

Nucleus RadioPharma is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.