Sterility Assurance Senior Manager

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 position of Sterility Assurance, Senior Manager at POINT Biopharma is responsible for the following:

• Provides sterility assurance oversight of the aseptic processing, environmental monitoring, and media fill programs.
• Serves as the microbiology subject matter expert for cleanroom qualifications, bioburden/sterility test method validations, sterilization validations, microbial recovery testing, environmental monitoring, and microbial identification.
• Supports regulatory audits as the sterility assurance subject matter expert.
• Leads cycle development for manufacturing processes including VHP cycles for isolator and hot cell systems, and autoclave units.
• Leads FMEA, continuous improvement and process development initiatives related to aseptic fill/finish activities.
• Provides leadership, training, and development for Microbiology Laboratory personnel in the microbiological testing of raw materials, RO purified water, cleanroom air/surfaces, and finished products.
• The position is based in Indianapolis, Indiana, U.S. and directly reports to the Senior Director, Quality Assurance/Quality Control.

Objectives

• To equip, staff, and lead a pharmaceutical microbiology laboratory that operates in full compliance with all regulatory standards, domestic and abroad.
• To ensure that all cleanrooms are sanitized, qualified, and monitored to maintain microbiological control per their designated room classifications.
• To ensure all sterile drug products produced and released at POINT Biopharma meet the defined sterility specifications in accordance with the established Quality Management System and all regulatory standards.

Accountabilities

• Achieving the company’s strategic goals through the management and leadership of the GMP Microbiology laboratory.
• Managing and leading the Microbiology laboratory and team members to effectively execute day-to-day testing in support of product manufacturing and new product transfers.

• Overseeing microbiological testing of raw materials, RO purified water, cleanroom air/surfaces, and final product.
• Overseeing sterility assurance compliance initiatives, including sanitizer efficacy validation, and qualification of various sterilization methods.
• Functioning as the subject matter expert during development of new aseptic manufacturing processes and associated master batch records, to ensure aseptic best practices and techniques are maintained.
• Reviewing results from environmental monitoring, sterility tests, growth promotion, microbial limits tests, microbial identification, and antimicrobial effectiveness tests.
• Tracking and trending environmental monitoring data, preparing reports, identifying adverse trends, and proposing CAPAs.
• Supporting aseptic training of manufacturing personnel involved in sterile drug product manufacturing.
• Ensuring internal compliance with aseptic operator qualification, process qualification and facility qualification through the media fill program.

• Assessing POINT’s qualification program to ensure ongoing compliance with regulatory standards.
• Assessing and managing changes and risk to aseptic process and fill/finish operations.
• Participating in regulatory inspections as subject matter expert.
• Coordinating cleanroom qualifications, laboratory equipment qualifications, test method validations, and employee qualifications.
• Writing/Reviewing out of specification investigations and non-conformances within the Microbiology lab.
• Functioning as the subject matter expert for review and assessment of quality events during manufacturing pertaining