logo

Manager of Analytical Chemistry & Quality Control

  • Anywhere

Company :
POINT Biopharma

Location :
Indianapolis, Indiana

Expiry Date :
Sat, 24 Apr 2021 23:59:59 GMT

Apply Job :
Open Link

Description :
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.

The Manager of Analytical Chemistry & QC Testing is responsible for the development, technology transfer, and ongoing analytical testing of POINT Biopharma radiopharmaceutical products. Based in Indianapolis, Indiana, you will report to the Senior Director QA/QC.

Your responsibilities will include:

* Achieving the companys strategic goals through the management and leadership of the GMP analytical testing laboratories.
* Managing and leading the analytical laboratory and team members to effectively execute day-to-day manufacturing requirements.
* Managing the preparation, quality control analysis, GMP investigations and supporting documentation activities related to pharmaceutical manufacturing of radioactive diagnostic and therapeutic drug products.
* Ensuring all drug products are manufactured to the highest standards of Good Manufacturing Practice (GMP), ICH guidelines, and according to regulatory guidelines, laws and Standard Operating Procedures (SOPs).
* Leading the technology transfer of analytical testing methods from the development phase into commercial manufacturing.
* Leading the development and validation of testing methods for new compounds to be produced under GMP manufacturing.
* Conducting chemical and physical testing of raw materials, API, in-process and finished products, using established test methods to provide accurate and reliable data to assure their strength, identity and purity.
* Preparing and maintaining accurate and complete QC analytical data in accordance with Good Documentation Practices for GMP manufacturing. Record and report results of analysis in accordance with prescribed lab procedures and systems.
* Participating in and contributing to the maintenance of analytical laboratory instruments and the manufacturing facility.

Requirements

Our Ideal candidate has:

* A BS/BA, Chemistry or similar technical field, with a MSc or PhD in field of science preferred
* 7-10 years of relevant industry experience within a GMP QC analytical laboratory
* Experience with HPLC testing and methodologies required
* Direct experience with analytic method development and validation
* Demonstrated knowledge, experience and successful track record in radio-pharmaceutical method development, technology transfer and method validation.
* Experience leading team(s) and mentoring and coaching others to achieve results.

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 cover letter and resume.

Benefits

* Health Care Plan (Medical, Dental & Vision)
* Retirement Plan (401k, IRA)
* Life Insurance (Basic, Voluntary & AD&D)
* Paid Time Off (Vacation, Sick & Public Holidays)

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.