Title: Associate Director of CMC Regulatory Sciences
Department: Chemistry
Reports to: CEO
Job Summary:
The Manufacturing Science CMC Lead is accountable for the lifecycle management of our radiopharmaceutical platform and represents the CMC team. This individual will serve as a technical expert with experience in chromatographic techniques (e.g., HPLC) and quantitative analysis. They will lead a cross-functional team to drive the CMC strategy. Experience handling radioactive materials (RAM) and experience in aseptic processing and ISO environments is a plus. Familiarity with cGMP manufacturing practices is required.
Duties/Responsibilities:
Plays a vital role in the development and execution of regulatory affairs CMC strategy for investigational and commercial drugs.
Responsible for the preparation of moderately complex regulatory submissions, including initial applications, amendments, supplements, responses to information requests, and annual reports
Proficient in cGMP regulations, quality systems, and regulatory requirements.
Accountable for CMC sections of production dossiers, including IND and NDA drafting (Module 3)
Review and approve technical (analytical) validation protocols and reports as appropriate.
Provides support for cGMP activities as they relate to regulatory affairs CMC, including Health Authority inspections, maintenance of local manufacturing licenses, etc
Provide Subject Matter Expertise in significant process and methods investigations
Advanced technical writing and excel skills are highly desired for creating and presenting reports.
Manage multiple workstreams and projects
Drives the link between CMC Strategy and CMC execution of the CMC subteam
Is the overall product/process expert for all products at RadioMedix SPICA Center
Required Skills/Abilities:
A relevant background in Quality Control or Analytical Development with a role as a supervisor or manager is highly desired
Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based on changing priorities.
Possess critical thinking skills when making sound quality decisions based on risk management and available data.
Technical expert with experience in chromatographic techniques (e.g., HPLC) and quantitative analysis
Excellent organizational skills and attention to detail
Strong analytical and problem-solving skills
Ability to work independently towards self-directed goals
Proficient with Microsoft Office Suite or related software
Strong proficiency with Microsoft Excel preferred
Education and Experience:
Higher degree in chemistry, biochemistry, or related field with a minimum of 6-10 years experience.
Physical Requirements:
Standard office environment, coupled with approximately 70% time in a clean room, radiopharmaceutical manufacturing, and laboratory environments.
Willingness to work in commercial manufacturing producing radioactive materials and safety programs designed to minimize potential and actual exposure levels.
Must be willing to wear a variety of personal protective equipment.
Responsibilities also include lifting up to 50 lbs., walking, bending, stooping, pushing, pulling, reaching, and climbing stairs with or without accommodation.
You may be required to sit or stand for long periods while performing duties.
Must be able to work outside of regular work hours, including weekends and overtime, as needed.
