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POINT Biopharma
Indianapolis, Indiana, US
Closing date
Dec 9, 2021

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Consultancy/Private Sector
Conservation science
Salary Type
Employment Type
Full time
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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 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.


Reporting into the Senior Director QA/QC the Microbiologist will serve as a subject matter expert for the GMP manufacturing operations and provide leadership, guidance, and support to Quality Assurance while ensuring aseptic manufacturing is executed in accordance with cGMP, ICH Guidelines and the FDA Code of Federal Regulations for aseptic drug products.

Key Objectives:

* To participate in the successful setup, qualification, training, and validation of the facility an personnel necessary to ensure product sterility assurance per regulatory standards.

* To ensure all sterile drug products produced at the manufacturing facility meet the defined sterility and endotoxin specifications and in accordance with the established Quality Management System.

* To ensure all drug products produced and tested under aseptic conditions are manufactured to the highest standards of Good Manufacturing Practice (GMP), ICH guidelines, and according to regulatory guidelines, laws and Standard Operating Procedures (SOPs).

Your responsibilities will include:

* Overseeing the microbiological testing of raw materials, in-process materials and final product, as well as the equipment and conditions in which aseptic manipulations take place.

* Performing technical review of batch filling records to ensure quality of aseptic processes.

* Read and interpret microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests and antimicrobial effectiveness tests.

* May perform validation, technology transfer and troubleshooting, and write policy procedure for quality initiatives.

* Reviews and approves environmental monitoring data and laboratory equipment and records.

* Perform organism identification.

* Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness.


* BS/BA degree in Biology, Microbiology, or Life Scienes required

* 1 3 years of laboratory experience. Pharmaceutical or Biotech industry experience is an asset.

* An excellent understanding and knowledge of microbiology and methods of testing for the presence of and identification of micro-organisms

* Experience with microbial species identification


* 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

* Demonstrated proficiency in Microsoft Office (including Outlook, Word, PowerPoint, Excel)

* Ability to collaborate with QA, CMC and regulatory colleagues to establish and justify release and stability specifications for starting materials, intermediates, drug substances and drug products

* Manage multiple projects, set priorities, and work in a fast-paced environment

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.


* 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.

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.
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