Website POINT Biopharma
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Company : POINT Biopharma
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. POINT’s active clinical trials include FRONTIER, a phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein-α (FAP-α), 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.
The Associate Director – Quality Assurance, reporting to the Sr Director of QA/QC, is responsible for managing the activities of Quality Assurance personnel.
The Associate Director Quality Assurance must balance coaching a technical staff, prioritization and staffing for routine production support activities, implementation of technical projects, and process optimizations.
The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation.
The position requires working cross-functionally within the site, network, commercialization teams, and other functions to deliver on technical objectives, specific product business plan, and quality objectives.
Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc.
Performance management and development of staff.
Partner within Quality Assurance and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives
Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits
Define strategic direction and provide oversight for setting the technical agenda to improve process control, yield, and/or productivity for all products within the site portfolio.
Ensure adequate oversight and technical excellence for investigations and complaints.
Ensure adequate oversight for technical projects to improve process control, capacity, yield, quality
Ensure adequate technical representation and engagement within site and network governance meetings to influence technical agendas.
Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites.
Potential to engage and influence Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization.
Escalate issues to management.
Batch record review (Executed and Master) for all stages of manufacturing
Promote a positive Quality Culture and oversee on-the-floor Quality presence in the respective business area (e.g., manufacturing).
Provide Quality direction for complex business and operational issues or technical challenges. Remove barriers as they arise.
Final disposition of finished product for commercial and clinical use, including country-specific release and collaboration with Qualified Persons (QPs)
Authoring and review of deviations, CAPAs, and change controls
Investigation of product complaints
Quality review of analytical documentation including: analytical methods; validation protocols and reports; specifications; and stability protocols, reports, and expiry extensions
Oversee and monitor Quality metrics. Ensure data compiled are communicated in relevant forums and escalate compliance issues/concerns to Quality senior management.
Review and approval of commercial and clinical product labels
Authoring/ revision of SOPs
Leading process improvements
Ensuring that GMP work at POINT and contract organizations is done in compliance with applicable laws, regulations, guidelines, and SOPs.
Participation on project teams and sub-teams as needed and assigned
Compose and review SOPs, protocols, reports, forms, and certificates of analysis.
Interact with auditors and regulatory inspectors.
Collaborate with other departments on projects, including inter-site and inter-company.
Mentor and develop direct reports.
Education and Experience:
Bachelor’s Degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or other related field.
5+ years of experience in Quality Assurance in a pharmaceutical manufacturing environment.
Proven track record of investigation (RCA) and CAPA implementation for the improvement of lab operations.
A minimum of 2 years of management/leadership experience is required.
Availability to support the testing activities of time-sensitive radiopharmaceuticals.
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)
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.
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
$50 cell phone reimbursement per paycheck ($1,300 per year)
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.