Senior Lead Analytical Chemist
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Job Summary
Job Description Summary
We are seeking a highly motivated Senior / Lead Analytical Chemist to play a key role in advancing a next generation Gallium based radiopharmaceutical within our Molecular Imaging pipeline from development into the clinic. The role combines analytical expertise and scientific guidance to support analytical strategies for precursor development and supply cold kit drug product development and the establishment and lifecycle management of phase appropriate analytical specifications and scientific rationales.You will join the Analytical Chemistry department which provides analytical expertise to support early phase research projects and New Product Introductions within PDx R&D. Working closely with other analytical scientists and cross functional partners you will act as a core analytical contributor to the program supporting robust regulatory ready analytical solutions across the clinical development lifecycle.
Job Description
Key responsibilities
- Lead external analytical method development and validation activities to support precursor manufacture supply and cold kit drug product development.
- Define and maintain analytical specifications and acceptance criteria for raw materials precursor and drug product through crossfunctional stakeholder alignment supported by sound scientific rationale.
- Ensure analytical strategies specifications and activities are phaseappropriate scientifically robust and compliant with ICH guidelines pharmacopeial requirements internal quality systems and regulatory expectations.
- Act as the analytical subject matter expert for the development program through the clinical phases.
- Prepare review and contribute to highquality internal analytical documentation supporting regulatory submissions (e.g. IMPD IND NDA/MAAenabling content).
- Collaborate closely with Pharmaceutical Development Radiochemistry Quality Assurance and Regulatory Affairs to define and execute fitforpurpose analytical strategies.
- Oversee and provide technical input to external CROs ensuring delivery against defined project scope and analytical requirements.
- Drive continuous improvement through the adoption of modern analytical approaches technologies and best practices.
Required qualifications
- MSc or PhD in Analytical Chemistry or a closely related discipline.
- Strong experience in chromatographic method development particularly HPLC-UV and HPLC-MS.
- Sound theoretical and practical understanding of analytical method development and validation.
- Experience generating regulatory-ready scientific reports and documentation.
- Ability to work effectively in a dynamic time-sensitive development environment.
- Excellent written and verbal communication skills in English.
Desired Characteristics
- Experience with cold kit and/or freezedried (lyophilised) drug product development radiochemicals or work in a radiopharmaceutical or radiochemistry laboratory environment.
- Handson experience with analytical techniques relevant to radiopharmaceuticals and lyophilised products such as thinlayer chromatography (TLC) radiometric/scintillationbased detectors and elemental analysis techniques (e.g. ICPOES and ICPMS).
- Experience working in GMPregulated GxP or accredited laboratory environments.
- Solid understanding of analytical requirements across the drug development lifecycle from early development through clinical phases.
- Familiarity with Quality by Design (QbD) principles and Design of Experiments (DoE) applied to analytical and product development.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition turn ideas into world-changing realities and join an organization where every voice makes a difference and every difference builds a healthier world.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus and drive ownership always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race color religion national or ethnic origin sex sexual orientation gender identity or age disability protected veteran status or other characteristics protected by law.
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Additional Information
Relocation Assistance Provided: No
Required Experience:
Senior IC
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About Company
GE HealthCare provides digital infrastructure, data analytics & decision support tools helps in diagnosis, treatment and monitoring of patients
