Senior Engineer

Company: POINT Biopharma Inc.
Location: Indianapolis
Posted on: September 17, 2023

Job Description:

POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT's active clinical trials include FRONTIER, a phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein--- (FAP---), and SPLASH, the phase 3 trial for PNT2002 for people with metastatic castration resistant prostate cancer (mCRPC) after second-line hormonal treatment. TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA. Location: Indianapolis, IN. Completed in Sept 2021, POINT's Indianapolis site is one of the largest state-of-the-art radiopharmaceutical manufacturing facilities in the world - almost as large as one and a half football fields.Overview POINT Biopharma is an innovative, high-performance company focused on a hard problem: extending and improving the quality of life for patients enduring cancer. Our products are targeted radioligands, a technology that holds significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment established our U.S. manufacturing center in Indianapolis and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA. Reporting to the Manager of Project Engineering, the Senior Engineer will: Engage with cross functional teams to ensure manufacturing system designs, processes, and procedures are created and accurate within established timing requirements in a GMP manufacturing facility. This engineering role will become a Subject Matter Expert on processing equipment in a clean room (classified environment) for clinical and commercial operations. The Senior Engineer will be responsible for understand and approving design details, assessing risk as it relates to equipment and processes, executing on project tasks, managing aspects of project implementation, following quality procedures (i.e., Change Control), create and execute validation requirements, and support manufacturing systems. Objectives

• Provide engineering direction from project concept through qualification on new and existing manufacturing systems.
• Review specification control drawings and other applicable specifications to determine requirements and/or feasibility of the component.
• Perform all necessary scientific and/or engineering studies and calculations.
• Prepare preliminary design proposals.
• Interact with production personnel to define and solve manufacturing/design issues and implement improvements.
• Perform liaison function between Engineering and all manufacturing operations for any related issues, problems, or improvements.
• Conduct risk analysis and develop risk mitigations actions.
• Create acceptance criteria and conduct acceptance tests.
• Prepare process validation protocols, execute, and document results.
• Interact and manage vendors concerning parts or equipment they supply or propose to supply.
• Prepare RFP (request for proposal) and RFQ (request for quotation) documents.
• Participate in engineering and general design review as required.
• Prepare technical data such as qualification test procedures, acceptance test procedures, reports, component maintenance manuals, etc.
• Direct the integration of technical activities and products.
• Evaluate and approve design changes, specifications, and drawings.
• Maintain specification and operational documentation as required.
• Keep manager advised of work status, workload, problems, and progress as related to work assignments.
• Prepare project plan, schedule, budget, and interim reports.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Provides a "Customer Service" attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintains a clean, orderly, and safe workstation and environment at all times. Accountabilities
  • Applies engineering and scientific principles to the evaluation and solution of equipment and system problems.
  • Managing projects and creating dashboards for report outs.
  • Effectively communicates moderately complex technical issues and solutions to a cross functional team.
  • Collaborating with cross-functional teams developing and executing tests, performing root cause analysis and participating in investigations.
  • Work requires the application of theoretical principles, evaluation, ingenuity and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study.
  • Exercises technical judgment in planning, organizing, performing, and/or coordinating engineering work. Remains abreast of and consults on technical advancements.
  • Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
    • Ability to properly don clean room garments on a frequent basis.
    • Prolong standing (> 6hr) may be required during production monitoring.
    • Capable of lifting to 40lbs on an occasional basis. Education and Experience:
      • Bachelor's degree in an Engineering discipline or equivalent from four-year college
      • 8+ years related experience
      • Position may be leveled based on experience of the candidate
      • Proficient in MS Office applications Critical Competencies:
        • Highly Organized
        • Self-motivated
        • Strong communication skills
        • Analytical mindset Why joining POINT today will be the right career move for you: There is no shortage of demand for smart, qualified and hardworking people like yourself - and we strongly believe POINT is the right career move for you. Here is why:
          • You will help establish and define an organization that will change the course of cancer therapies. and help thousands of people each year
          • You will be challenged, and are expected to challenge us, as part of a results-oriented, high performance team, where everyone leaves their egos at the door and lets the best ideas win
          • You will be provided the opportunity to participate in the financial value creation that occurs as POINT grows and becomes a mature pharmaceutical company
          • Most importantly, you will spend everyday working on something important If what we are saying resonates with you, please submit a resume.
            • Eligible for annual incentive bonus plans and stock options
            • Health Care Plan (Medical, Dental & Vision) - 85% paid by employer and effective day 1
            • Retirement Plan (matching 401k)
            • Income Protection Insurance - (Life AD&D, Short & Long-term disability) - 100% employer paid
            • Voluntary Income Protection - Premiums paid by employee
            • Paid Time Off (Vacation, Personal Days, Sick Days & Public Holidays)
            • $500 fitness reimbursement per year
            • $100 cell phone reimbursement per month All applicants who are offered employment with POINT Biopharma will be subject to a background investigation. Offers of employment are contingent on the successful completion of a background investigation conducted in accordance with POINT Biopharma policy and state law. POINT Biopharma does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. We do not accept unsolicited inquiries or resumes from agencies.

Keywords: POINT Biopharma Inc., Indianapolis , Senior Engineer, Engineering , Indianapolis, Indiana