Principal Scientist CMC Process Improvement
Principal Scientist CMC Process Improvement
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Salary Not Disclosed
1 Vacancy
Job Description
Lantheus is headquartered in Bedford Massachusetts with offices in New Jersey Canada and Sweden. For more than 60 years Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.
Lantheus is an entrepreneurial agile growing organization that provides innovative diagnostics targeted therapeutics and artificial intelligence (AI) solutions that empower clinicians to find fight and follow disease.At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someones health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.
Job Summary
Provides extensive scientific expertise strategic leadership and deep knowledge of regulatory frameworks in radiopharmaceuticals. This seniorlevel role requires a wellrounded individual who can drive drug process development and manufacturing strategies lead crossfunctional teams and ensure compliance with USA government regulations related to radiopharmaceuticals.
As a Principal CMC Contributor you will play a key role in the development and of strategies that shape the future of radiopharmaceutical products from earlyphase development to commercialization.
Essential Functions
Lead and contribute to the scientific understanding and technical strategy of drug development particularly in the radiopharmaceutical sector. Provide deep expertise in chemistry manufacturing and controls to support the development of new radiopharmaceutical products. Demonstrates knowledge and expertise in applying all aspects of advanced chemistry and engineering principles to the design and development of both current and new radiopharmaceuticals.
Leverage extensive knowledge of U.S. FDA regulations including 21 CFR Parts 210 211 and 212 as well as other government regulations specific to radiopharmaceuticals (e.g. cGMP IND NDA) to ensure compliance during the drug development lifecycle. Navigate regulatory submissions and provide strategic advice for regulatory approvals.
Lead and mentor crossfunctional teams including scientists regulatory experts quality control and production teams. Guide team members in problemsolving and strategy while fostering a collaborative and highperformance environment.
Lead efforts in the development of scalable efficient and robust manufacturing processes for radiopharmaceuticals. Drive the design optimization and validation of manufacturing processes from preclinical through clinical and commercial phases.
Define the strategic direction of CMC activities including timelines budgets and resource allocation in alignment with organizational objectives. Provide leadership on highlevel CMC strategy overseeing technical risk management and ensuring alignment with company goals.
Ensure the preparation and timely submission of regulatory documents including CTD modules CMC sections for IND/NDA/BLA submissions and other regulatory filings. Provide scientific and technical writing expertise for regulatory documentation.
Serve as a key liaison between CMC clinical development regulatory affairs quality assurance and manufacturing teams to ensure effective and clear communication across all areas involved in product development.
Maintains stateoftheart knowledge of in the field of radiopharmaceutical development and contribute thought leadership within the organization. Promote support of intellectual property protection. May be responsible for preparing and defending patent disclosures and applications.
Actively promotes safety rules and awareness. Demonstrate good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
Actively demonstrates the Lantheus values of Helping people be their best; Respect one another and act as one; Learn adapt and win; Know someones health is in our hands; and Own the solution and make it happen.
Typical Minimum Skills Experience and Education
Ph.D./M.S./B.S. Chemistry Pharmaceutical Sciences Chemical Engineering or a related field (or equivalent industry experience).
Indepth understanding of U.S. FDA regulations and guidelines for radiopharmaceuticals including experience with IND NDA and BLA submissions. Knowledge of international regulatory requirements (EMA ICH) is a plus.
At least 10 years of experience in CMC within the pharmaceutical or biotechnology industry with a focus on radiopharmaceuticals. Proven experience in drug process development including handson experience in the scaling and optimization of manufacturing processes.
Other Requirements
Expertise in chemistry manufacturing and controls of radiopharmaceuticals.
Strong project management skills including budget timeline and resource management.
Excellent written and verbal communication skills.
Proficient in regulatory submission processes and scientific writing.
Demonstrated ability to effectively communicate ideas and information both in oral and written form at a variety of audience expertise and comprehension levels.
Experience with the full lifecycle of radiopharmaceutical products from earlyphase development to commercialization.
Familiarity with manufacturing technologies including radiochemistry formulation development and GMP operations for radiopharmaceuticals.
Lantheus is committed to equal employment opportunity and nondiscrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Lantheus is an EVerify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at .
Required Experience:
Staff IC
Employment Type
Full-Time
