Sacramento, California, United States Updated: Friday 24 May 2024
Responsible for manufacturing clinical and preclinical radiopharmaceuticals. Be part of tech transfer team to bring new radiotracers on board for clinical research. Supporting team members/technicians to ensure operational as well as patient standards are consistently maintained; ensures production of PET radiopharmaceuticals to clinical and pre-clinical researchers, pharmaceutical companies, and radiopharmaceutical development companies. Services the development and optimization of generic and novel PET radiopharmaceuticals in a current good manufacturing practice (cGMP) environment. Write and effectively execute protocols in conformity with the requirements outlined in 21 CFR Part 212 and USP <823>.
Sets up and prepares the chemistry units for synthesis and production in a cGMP environment in a manner that sets high standards conducive to leading by example.
Is the subject matter expert for radiochemistry tech transfer and manufacturing qualification of newly developed radiotracers that will be qualified for clinical trial production.
Performs quality control activities including HPLC, TLC and GC completion of batch records and packaging of the radiopharmaceuticals for transport in accordance with all regulatory requirements.
Participates and designs studies to assist in product development of global Telix radiopharmaceutical assets.
Assist Radiation Safety Officer to ensures complete documentation and compliance of the program; ensures safety procedures are practiced consistently meeting radiation safety and EHS activity standards in the lab.
Help to maintain operation of the lab and its instruments including the Quality Management program; provide regular maintenance and repair of instruments or equipment, if needed.
Responsible for reviewing and executing batch records for clients and drug sponsors.
Assist in the writing of the CMC portion of INDs to support future clinical trials
Master of Science or PhD
Experience with routine PET diagnostic tracers (11C, 18F, 68Ga) is required.
Experience with radiometal chemistry processes (89Zr, 177Lu, 64Cu, etc) is preferred.
Training as an Authorized User for radioactive materials preferred.
Experience in radiopharmaceutical production, QC, and laboratory operations.
Knowledgeable in current GMP/GLP and other regulatory requirements.
The Sales Training Lead is responsible for acting as a strategic partner to the business in employee development and program management, while delivering the highest level of clinical and compliance sales training. This includes developing, delivering, and managing training programs to new and experienced sales personnel. The Sales Training Lead will work with Sales Management and other Telix Department Leaders to implement and execute training strategies to address the needs and skill gaps of the US Commercial team.
Areas of focus will be onboarding, new hire training, advanced training, product messaging, and sales enablement tools, including Mindtickle (LMS), Salesforce, and MedScout.
Own all training phases: onboarding, new hire training (including home study), advanced training, and ongoing training for all of field sales.
Oversight of new hire onboarding for all US hires including program management and speaker scheduling.
Ownership of content creation, delivery of content and assessing training effectiveness for the field sales team.
Collaborate with Americas sales leadership, marketing, and other internal stakeholders to identify training needs and work to create and deliver content to address the needs of the business.
Maintenance of TAM training program, including identifying ways to continuously improve and deliver.
Work with regional teams via monthly/bi-monthly field travel, in-person/Zoom client meetings, and/or by attending regional meetings.
Create and update resources and reference materials for the sales team as needed.
Oversee the Learning Management System (LMS) by creating and managing content, providing reviews and overseeing coaching activities.
Work with field sales leadership in the development of training plans and appropriate customer messaging.
Facilitate in-person training, when appropriate, and coordinate logistics.
Work with the training and sales teams to plan, organize and project manage meetings such as National Sales Meeting, Regional/Area Meetings, Product Launches, etc.
Act as a subject matter expert for Telix products to provide clarification when product-related questions arise.
Incorporate best practices for adult learning strategies and continuously improve on the content created.
Partner with the field sales teams to participate in field rides, meetings and events.
5+ years’ experience in a working in a pharmaceutical sales role, developing and delivering training, or a combination required.
Experience with a Learning Management System required; Experience with Mindtickle preferred.
Prior experience with Salesforce, Definitive Healthcare and MedScout preferred.
Exceptional communication skills – including the capability to digest a plethora of information at once, help distill information for training purposes, and articulate the information in a clear and concise manner in both oral and written presentations.
Ability to build and maintain relationships with internal/external stakeholders.
TLX Price at posting:
$15.47 Sentiment: Buy Disclosure: Held
(20min delay)