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
Didn't find what you're looking for? Search again!
Loading more jobs...