Associate Director MSAT
Associate Director MSAT
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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.
Summary:
The Associate Director of MSAT is responsible for providing technical leadership and support for manufacturing processes in a GMPregulated pharmaceutical environment. This role supports technology transfer process validation product lifecycle management and continuous improvement initiatives across a range of internally and externally manufactured products. The individual will work crossfunctionally with Manufacturing Quality Engineering and Regulatory teams to ensure robust efficient and compliant manufacturing processes.
Process Support & Technical Leadership:
- Serve as the technical lead for troubleshooting and optimization of commercial and clinical manufacturing processes.
- Lead process validation and continued process verification (CPV) efforts ensuring compliance with regulatory expectations.
- Own and drive deviation investigations root cause analysis (RCA) and CAPA implementation related to manufacturing issues.
- Develop and execute process risk assessments (e.g. FMEA) to ensure process robustness and reliability.
- Ensure adherence to FDA EMA ICH and other global regulatory requirements for pharmaceutical manufacturing.
- Author and review CMC sections of regulatory filings and support regulatory inspections.
- Maintain and continuously improve SOPs batch records and validation documentation in alignment with GMP best practices.
- Drive process improvement projects to enhance yield efficiency cost reduction and sustainability in manufacturing.
- Stay updated on emerging manufacturing technologies industry trends and regulatory expectations to implement best practices.
- Manage and mentor a team of MSAT engineers and scientists fostering a culture of technical excellence and innovation.
- Act as a key liaison between Manufacturing R&D Quality and Supply Chain to ensure seamless operations and tech transfer.
Typical Minimum Skills and Experience and Education:
- Requirements include a B.S. or M.S. in relevant scientific/technical disciplines advanced degrees (e.g. PhD) or technological certificates preferred but not required.
- 10 years of work experience within pharmaceutical or medical device industry 5 years of manufacturing process development process validation and technical transfer within a matrixed pharmaceutical medical device or biotechnology organization.
- Previous experience working with aseptically filled/finished drug products medical device radiopharmaceuticals and CMO management strongly preferred.
Other Requirements:
- Must be able to effectively communicate program objectives and risks with internal teams and external partners and drive crossfunctional alignment.
- Project management experience is necessary to ensure plans are developed to mitigate technical and logistical issues to keep programs on their agreed upon timelines.
- Proven ability to drive performance collaborate and resolve technical issues are critical skills. Knowledge of regulatory process development and validation requirements are important to ensure compliance.
- Subject matter expert (SME) in sterile injectable manufacturing: aseptic processing sterilization sterile filtration isolator technology operations. Strong knowledge of global regulatory requirements and audit experience.
- Excellent organizational skills and the ability to successfully manage a multitude of complex technical projects.
- Demonstrated management sociable and ability to work in team. Strong mentor with excellent people development skills and track record.
- Experience working with external partners is highly desirable.
- Travel may be required and is dictated by product needs and project deliverables including occasional overnight travel to Lantheus and CMO locations.
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:
Director
Employment Type
Full-Time
