Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas.
A Process Engineer I job is to develop, evaluate, transfer and implement manufacturing processes for liposomal drug products. They will use technical knowledge and industry expertise to define, characterize, and document cost-effective production processes within a business. This position requires the ability to execute and interpret experiments with minimal guidance, routine writing and reviewing of technical documents (e.g. development reports, work instructions), and daily interaction and collaboration with team members as part of cross-functional teams. Knowledge of cGMP manufacturing, design controls and experimental design is strongly preferred.
Instituting quality assurance methods is also a job duty of the Process Engineer. This requires the Engineer to confer with formulation scientists and researchers to simulate production or create test trial products. These professionals may then review both the development process and final product to ensure it meets industry standards and complies with government laws and regulations.
The Engineer may also act as a project lead and analyze new equipment, technology, or machinery to implement in the production process. For example, these professionals may evaluate new materials, equipment, automation, etc. This role may then design specifications for product use, create schedules for implementation, and oversee installation.
The mission for the role is to support process development and optimization of drug product manufacturing processes as well as tech transfer activities related to such processes.
Essential Duties and Responsibilities
Responsible for Process Development Projects including:
• Definition of Process Input Requirements
• Characterization of processes including definition of Critical Process Parameters and Critical Quality Attributes
• Execute well-controlled experiments and analyze and interpret results
• Support the development of new processes as defined by approved project plans
• Support verification and validation activities (Equipment and process in alignment with cGMP requirements)
• Documentation of methods, processes and tools
• Communicate project statuses and experimental results, conclusions, and ideas directly to supervisor, “project team” members, scientists and engineers in other laboratories
• Write experimental protocols, development reports, and SOP’s with minimal supervision
• Participate on project teams in construction of or adherence to departmental/company timelines
• Conduct trouble shooting activities related to production (e.g., technical, equipment, and process performance issues
• Assist in the definition of the role of Process Development in the broader organization in support of commercial products, product sustaining and development support
• Responsible for specific portions of the overall process development within PLUS Therapeutics.
• Work closely and collaboratively with Development Engineering, Analytical Chemistry, and Clinical/Quality/Regulatory
• Close Process Development projects in a timely manner
• Familiarize with strengths and weaknesses of Equipment, Processes and Test Methods
Education and Experience:
• Bachelor’s degree in chemistry, biological sciences, engineering discipline, or equivalent experience.
• Basic knowledge of the product development approaches.
• Basic knowledge of hypothesis experiment testing.
• Basic knowledge of analytical testing methodologies
Skills – Technical
Advanced Microsoft Office skills:
• Excel: Forms, Formulas, Functions, Pivot Table, & Graphs
• PowerPoint: Graphics & Animation
• MS-Project: Resource loading, tracking
• Minitab or statistical analysis programs desirable
• Change Order writing/review
Skills – General
• Be a self-motivated, customer-oriented person with excellent communication skills
• Work professionally with colleagues and be a team player; maintain flexibility with work projects
• Complete work in a timely, accurate and thorough manner
• Think and work both tactically and strategically to provide operational needs to the business
• Ability to read, write and analyze complex documents
• Respond effectively to sensitive inquiries, customer inquiries or complaints as well as communicate effectively both orally and in writing with management, colleagues and outside constituents
• Strong problem-solving, judgment and decision making skills are required
The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and laboratory environments and automated equipment.
While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus. The employee must have the manual dexterity and manual ability to effectively use computer terminals.
Equal Employment Opportunity
Plus Therapeutics, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws.
Life and Disability Insurance
401k with Company Match
…as well as additional benefits
CANDIDATES: please send cover letter and resume to [email protected]