What are the responsibilities and job description for the Director, Clinical Trial Manufacturing position at Aktis Oncology?

AKTIS Oncology is a biotechnology company pioneering the discovery and development of a new class of targeted radiopharmaceuticals to treat a broad range of solid tumor cancers. Founded and incubated by MPM Capital with its seasoned team of entrepreneurs and drug developers, AKTIS has developed proprietary platforms to generate tumor-targeting agents with ideal properties for radiotherapy.

Designed for high tumor penetration and long residence time, AKTIS Oncology's molecules can quickly clear other areas of the body, thereby maximizing tumor elimination while minimizing side effects of treatment. These are therapies that would also enable clinicians to visualize and verify target engagement prior to exposure to therapeutic radioisotopes.

The Director of Clinical trial Manufacturing will lead the activities related to the internal radiopharmaceutical manufacturing facility to support Aktis investigational products (theragnostic). The candidate will develop and maintain the manufacturing operations in alignment with the company portfolio needs and the clinical demand and will be responsible for the day-to-day operations of the manufacturing department, including production planning, scheduling, and resource allocation.

BACKGROUND AND QUALIFICATIONS

Minimum BS in Chemistry or Engineering or a related field preferred
Experience in clinical development and manufacturing in the biotechnology or pharmaceutical industry with a minimum of 10 years experience in Radiopharmaceutical cGMP operations, including aseptic process, equipment, and process qualification
Understanding of the nuclear safety regulations, and associated guidelines
Proven track record in operational management of technology transfer, and process validation.
Experience working with antibodies, imaging, and therapeutics radiometals
Skilled in organizational development, personnel management, and budget and resource development
Knowledge of the drug approval process, and experience overseeing or working on the team tasked with gaining FDA approval of both branded and generic products
Excellent communication skills

ESSENTIAL DUTIES AND RESPONSIBILITIES

Hire and oversee qualified personnel in the manufacturing operations

Oversee the manufacture of products, ensuring production, performance, and quality standards are consistently met

Ensure a healthy and safe working environment, and compliance with federal and state regulations, through collaboration with environmental, health, and safety staff

Maintain all records as mandated by state and federal regulations for a radiopharmaceutical manufacturing facility

Proven leadership and management skills with the ability to optimize team performance and development

Supervises equipment purchase, maintenance, and layout

Responsible for driving the organization to achieve and surpass organizational productivity goals and meeting all quality and regulatory requirements

Lead the execution of the process qualification and validation campaign and prepare the relevant reports and data for the relevant IND sections

Contribute to writing CMC sections and supporting reports for submission to regulatory agencies

Execute clinical readiness activities (such as compatibility and transportation studies, and aseptic process qualification) to enable clinical manufacturing

Maintain KPI and internal reports

Partner with internal CMC team, provide technical direction to author manufacturing documentation including specification, analytical method, batch records, protocols, etc

Partner with Quality to provide periodic technical review of manufacturing data, including analysis of trends

Partner with Quality, Supply Chain, and external manufacturing, identify opportunities for risk reduction and continuous improvement within the cGMP manufacturing process

Provide technical impact assessment to support Quality / Regulatory assessments including but not limited to batch release, change control, quality events (deviations, OOs, CAPAs)

Take on new challenges willingly and build a culture of rigor and data-driven decision-making to bring novel therapies to the clinic

Demonstrate high standards for scientific rigor, team behaviors, excellence, and a culture of innovation that is fully aligned with company objectives

Demonstrate tenacity and drive for enterprise benefit

Strong desire to be part of a mission-oriented company leading transformative change for patients.

Proven demonstration of transparent communication and fostering open and diverse debate.

Ability to work with agility and manage ambiguity.

Personifies positive energy and exemplifies respect.

Aktis Oncology is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

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