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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. POINTs 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

The position of Senior QC Manager, Microbiology 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 companys 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 POINTs 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 to sterility assurance
Compiling, monitoring, and presenting key performance indicators for all microbial testing.

Requirements

Education and Experience:

BS/BA degree in Biology or Microbiology required.
8 years of Quality Microbiology work experience in a cGMP environment.
At least 4 years of leadership/managerial experience.
Advanced knowledge of cGMP's, FDA, USP regulations and guidelines, as related to the manufacturing and testing of sterile parenteral drug products.
Advanced knowledge of microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques, etc.
Experience creating and executing sterility validation studies, such as media fills, autoclave performance validations, and VHP system performance validations.
Strong understanding of environmental monitoring programs, aseptic gowning, tools and techniques.
Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environment.
Advanced mentoring and coaching, influencing, negotiating, and personal interaction skills
Demonstrated resource management and planning skills.
Experience in performing and leading risk assessments.

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
Demonstrated proficiency in Microsoft Office (including Outlook, Word, PowerPoint, Excel)
Manage multiple projects, set priorities, and work in a fast-paced

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

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