Associate Director, Radiopharmaceutical Development
4 weeks ago
This leader will be responsible for developing our Pb212 drug candidates from the beginning to the end of their clinical trials. He or she will be responsible for setting up the technical transfers necessary to support clinical trials. An expert thinker with technical proficiency in radiopharmaceuticals will be the successful candidate, who will build a fresh platform paradigm focusing on Pb212. Radio metal chemistry, radio-formulation development analytical expertise, CMC writing and the ability to integrate learnings and failures from others are some things the lead must have.
Main Duties and Responsibilities
* Establish a robust development protocol and validation plan for the platform, spanning from the preclinical stage to the clinical scale-up stage.
* Establish a comprehensive technical process for Pb212-drug candidates to facilitate the transfer and management of a productive manufacturing process to our CDMOs. This process encompasses the identification and implementation of appropriate manufacturing and quality control procedures, equipment, and facilities.
* Enhance internal technical and operational capabilities to develop the platform, including ongoing monitoring, enhancement, and troubleshooting in the scope of process manufacturing and process control, including quality assurance and release time.
* Organize, manage, execute technology transfer to CDMOs.
* Build the KPI scorecards to monitor CDMOs performance, troubleshooting.
* Continuous improvements to reach manufacturing efficiency >90%
* Select and qualify suitable raw materials and ingredients that conform to regulatory requirements.
* Develop an operational excellence mindset to develop a fast process of manufacturing and quality control to handle the shelf life of Pb212.
* Co-write the dossier with the CMC.
* Establish procedures for good manufacturing practices, safety, reliability, and a commitment to excellence.
* Consider the continuous evolution of the platform from preclinical to clinical when designing new R&D spaces.
* Development formulation from preclinical to clinical phase in accordance to FDA and EMEA guidance
* Motivate and steer a group of radiopharmaceutical advancements in executing the technical and operations tactical plan, ensuring that projects are delivered on schedule, within budget, and in line with the required high-quality standards.
* Improve the ARTBIO process by identifying, integrating, and improving on learnings from experience in Pb212 generators and drug candidate manufacturing.
* Develop and maintain relationships with key suppliers and service providers to ensure the reliable and efficient supply of raw materials, equipment, and services.
* Ensure compliance with all relevant regulations, standards, and guidelines, including those relating to quality, safety, and environmental impact for our CDMOs, internal R&D and own projects.
* Identify and implement procedures that improve effectiveness, decrease expenses, and improve the security and reliability of the radiopharmaceuticals offered by ARTBIO.
* Communicate effectively with all stakeholders, including management, clients, vendors, and regulatory bodies, to make sure everyone understands the company's strategic goals and objectives.
* Keep up with the latest technological advancements and market developments in the field of alpha radio ligand therapy development and offer direction to the top management team on how ARTBIO can take advantage of these developments to boost its competitive edge.
Qualifications & Experience Required
* PharmD, PhD in Radio-Chemistry, Chemical Engineering, Radiopharmaceuticals or related fields within life sciences.
* Minimum of 5 years of experience in the radiopharmaceutical field, with a focus on manufacturing and process development.
* Demonstrated experience in developing and operating complex technologies, ideally in the field of radio ligand therapy.
* Experience managing a team of technical persons and scientists, with a track record of delivering projects on time, within budget, and to the required safety and quality standards.
* Strong technical knowledge and problem-solving skills in formulation, radiolysis, process validation, qualification of synthesis module, RadioTLC, RadioHPC, Germanium detector and radiopharmaceuticals, with the ability to think strategically and communicate effectively with cross-functional colleagues in particular preclinical and safety stakeholders.
* Excellent organizational and project management skills, with the ability to prioritize and multitask effectively.
* Familiarity with relevant regulations (FDA, EMA), standards, and guidelines, including those relating to quality, safety, and environmental impact.
* Excellent know-how on regulatory requirements related to drug development.
* Familiarity with current US and EU regulatory requirements for therapeutic products.
* Written and verbal fluency in English.
#J-18808-Ljbffr
-
Cambridge, United States Artbio Full timeThis leader will be responsible for developing our Pb212 drug candidates from the beginning to the end of their clinical trials. He or she will be responsible for setting up the technical transfers necessary to support clinical trials. An expert thinker with technical proficiency in radiopharmaceuticals will be the successful candidate, who will build a...
-
Associate Director
2 days ago
Cambridge, United States Avalyn Pharma Inc Full timeJob DescriptionJob DescriptionBenefits:401(k) matchingCompany partiesCompetitive salaryDental insuranceHealth insuranceOpportunity for advancementPaid time offParental leaveStock options planVision insuranceWellness resources Associate Director / Director, Product Development Company Overview:Avalyn Pharma is developing innovative, inhaled therapies to...
-
Associate Director Director Product Development
23 hours ago
Cambridge, United States Avalyn Pharma Inc Full timeBenefits: 401(k) matching Company parties Competitive salary Dental insurance Health insurance Opportunity for advancement Paid time off Parental leave Stock options plan Vision insurance Wellness resources Associate Director / Director, Product Development Company Overview: Avalyn Pharma is developing innovative, inhaled therapies to target the lungs for...
-
Associate Director
1 day ago
Cambridge, United States Avalyn Pharma Inc Full timeJob DescriptionJob DescriptionAssociate Director / Director, Product Development Company Overview:Avalyn Pharma is developing innovative, inhaled therapies to target the lungs for treatment of rare respiratory diseases, including idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Avalyn completed an oversubscribed $175M Series C...
-
Associate Director of Research
2 weeks ago
Cambridge, United States Harvard University Full timeBasic Qualifications Bachelor's degree in a related field and a minimum of seven years of relevant work experience Additional Information This is a one-year term appointment with potential for renewal subject to funding and departmental need. We regret that Harvard Law School is unable to provide visa sponsorship for staff positions. All offers to be...
-
Associate Director PKDM
4 days ago
Cambridge, United States Strivector Full timeTHE EMPLOYER Take your career up a few notches with this an innovative global healthcare company, who chase the miracles of science to improve peoples lives. THE JOB Responsibilities This is a Associate Director PKDM position and requires someone who is a dynamic individual to serve as a PK/PD expert participating in multidisciplinary teams for clinical...
-
Associate Director, Contracts
4 weeks ago
Cambridge, Massachusetts, United States Job Juncture Full timeWere looking for a full time Contracts Associate Director with 10+ years of Department of Defense contracts experience, to lead and manage a small team of Contracts professionals and direct all aspects of contract management activities for the business, including proposal support and negotiation, post- award administration, change management, and...
-
Senior Scientist, Radiochemistry
4 weeks ago
Cambridge, United States ARTBIO Full timeJob DescriptionJob DescriptionSalary: SummaryWe're seeking a Senior Scientist in Radiochemistry who will be responsible for technically designing, managing, and executing a radiopharmaceutical development and manufacturing plan for Pb212-drug candidates. The successful candidate will support radiolabelling. metal complexation, and formulation for our new...
-
Cambridge, United States MOMA Therapeutics Full timeMOMA Therapeutics is looking for an experienced Associate Director/Director, CMC Program LeadershipImagine joining a company where you.... Will be part of an experienced and resilient team that is collectively unstoppable, trusts one another, and selflessly collaborates Will work with incredible humans who are committed to the discovery of transformative...
-
Associate Director of Security
7 days ago
Cambridge, United States Harvard University Full timeThe Office of Physical Resources & Planning (OPRP) provides complete and integrated planning and design services, construction management, and building renewal, maintenance, and operations management to maintain the physical resources of the FAS camp Security, Director, Associate, Operations, Financial Planning, Management
-
Associate Director, Omnichannel Marketing
2 days ago
Cambridge, United States EPM Scientific Full timeAssociate Director of Omnichannel MarketingI am partnered with a large biotech company looking for a marketing professional to join the Business Insights & Operations team to help develop and implement HCP and patient omnichannel marketing strategies for the company's rare disease portfolioKey Responsibilities:Work cross-functionally with the marketing and...
-
Associate Dean and Director, CARE Team
2 weeks ago
Cambridge, United States Massachusetts Institute of Technology Full timeASSOCIATE DEAN AND DIRECTOR, CARE TEAM, Student Support and Wellbeing, to lead a dynamic team supporting MIT students in acute distress. Will lead one of the Institute's most critical, highest functioning, and collaborative teams, the CARE Team Netwo Director, Associate, Dean, Support
-
Director, Analytical Development
6 days ago
Cambridge, United States Orbital Therapeutics Full timePosition Summary: Orbital is seeking an experienced Director of Analytical Development who will be responsible for leading, directing, and implementing a comprehensive analytical strategy in support of programs within vaccine, immunomodulation, and protein therapeutics. This highly accountable, high integrity individual will also lead, motivate, and grow the...
-
Cambridge, United States Agios Pharmaceuticals Full timeAssociate Director, Scientific Communications and Publications Who we are: Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selv Communications, Director, Associate, Communication, Internal, Clinical, Business Services
-
Cambridge, United States Scholar Rock Full timeThe Associate Director/Director, Early Access Program, is responsible for day to day management and operations of our early access programs (EAPs) including management of vendors and sites participating in our programs. This individual also works closely with cross-functional teams to ensure that these programs are conducted in a timely, efficient fashion...
-
Associate Director of Student Life
7 days ago
Cambridge, United States Harvard University Full timeBachelors degree or equivalent work experience required Minimum of 5 years relevant work experience FULL BASIC QUALIFICATIONS: Bachelors degree or equivalent work experience required in psychology, social work, or related field. Minimum of 5 years Director, Associate, Mental Health, Student
-
Associate Director, Insights
2 weeks ago
Cambridge, United States Biogen Full timeAbout This Role As the Associate Director of Insights & Analytics (I&A) Strategy and Communication, you will play a key role in translating data into insights and communicating them across teams. You will work closely with the I&A teams across all th Director, Communication, Strategy, Analytics, Associate, Operations, Technology, Business Services
-
Associate Director, Research Finance
4 weeks ago
Cambridge, United States MIT Full time**ASSOCIATE DIRECTOR, RESEARCH FINANCE**, _Office of the Vice President for Research (VPR)-Research Administration Services (RAS)_, to serve as the leader for research finance, providing sponsored research financial oversight, advice, and management on behalf of MIT-wide research administration to faculty/principal investigators, schools/college/areas, and...
-
Associate Director Pharmacology
4 days ago
Cambridge, United States Greenfield Source Full timeThis is an Associate Director level Pharmacokinetics, Dynamics, and Metabolism (PKDM) role. This department contributes to the safe and effective therapeutic treatment of each patient by applying appropriate pharmacokinetic (PK) and pharmacodynamic (PD) principles to drug development and accelerating the process, where possible. PKDM generates, integrates,...
-
Associate Director Pharmacology
2 weeks ago
Cambridge, United States Greenfield Source Full timeThis is an Associate Director level Pharmacokinetics, Dynamics, and Metabolism (PKDM) role. This department contributes to the safe and effective therapeutic treatment of each patient by applying appropriate pharmacokinetic (PK) and pharmacodynamic (PD) principles to drug development and accelerating the process, where possible. PKDM generates, integrates,...