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POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold 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.
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
The Senior Validation Specialist will be responsible for planning, scheduling, and executing all validation and qualification activities for GMP equipment, cleanrooms, and utilities systems at the Indianapolis manufacturing site, as well as providing support to vendor installation and commissioning activities.
The position is based in Indianapolis, Indiana, U.S. and reports directly to the Manager, CQV (commissioning, qualification, and validation).
Objectives
Leads the development of validation protocols and reports to support site validation activities, and ensures these documents are completed in accordance with cGMPs and compendial requirements for manufacture and distribution in North America and the EU.
Ensures appropriate validation activities are included in site or team project plans including tasks, manpower requirements, and duration. Maintains appropriate communication with senior leadership to ensure project plans are executed on time.
Oversees third-party service providers and vendors with respect to qualification, calibration, and validation activities. Provides direct support with respect to vendor installation and commissioning activities.
Investigates and assists in resolving deviations/exceptions from the predefined acceptance criteria. Participates in the development of and review of equipment requirements and specifications.
Leads the development of validation master plans for novel programs.
Assesses the impact of site changes and unplanned events on the qualified/validated state of equipment and programs. Manages changes utilizing change control process and provides input to engineering and facilities change management.
Supports regulatory filings and provides input during inspections with FDA or other regulatory bodies.
Accountabilities
Remain knowledgeable and current on manufacturing processes, quality systems, and relevant GMP related to validation.
Provide subject matter expertise for overall validation and calibration program, as well as improvement initiatives, CAPAs and change controls.
Maintain complete and accurate documentation of all work performed and excellence in writing technical reports.
Provide support to other Point team members to ensure reliability of all business activities.
Adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements.
Timely completion of all projects.
Requirements
Education and Experience
- Bachelor of Science degree or equivalent required.
- 5+ years relevant experience in validation and GMP.
- Experience in project management, test design, process flow, and troubleshooting.
- Demonstrated proficiency in Microsoft Office (including Outlook, Word, PowerPoint, Excel).
- Proficiency in manage multiple projects, setting priorities, and working in a fast-paced environment.
- Ability to read blueprints, repair manuals, schematics, and other technical documents.
- Experience using precision measuring instrument and electronic testing devices.
Competencies
- Excellent oral and written communication skills
- Demonstrated ability to function well in a collaborative team environment
- Ability to plan, develop and execute multiple projects under tight timelines
- Operate and execute with an extreme sense of urgency
- Excellent organizational and interpersonal skills
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.
Benefits
- 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.
POINT Biopharma
