Sr. Scientist CMC Analytical Development
Company: Lantheus
Location: Billerica
Posted on: October 19, 2024
Job Description:
Description
Lantheus is headquartered in Bedford, Massachusetts with offices in
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. In 2023, Lantheus had more than $1B in revenues, led by
sales of imaging agents for cardiac ultrasound and for prostate
cancer.
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 someone's 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 of roleThis Billerica based position reports to Senior
Director of Manufacturing Technology & Development (MT&D). This
is a small molecule & radiopharmaceutical focus analytical
development role supporting new and improved analytical methods and
commercial processes, physico/radiochemical characterizations in
support of late phase pharmaceutical development, technology
transfer to Contract Manufacturing Organizations (CMO), and
authoring CMC non-clinical dossier sections.
Key Responsibilities/Essential Functions
- Work with minimal supervision to achieve personal objectives,
within Lantheus SOPs and governing regulations, while realigning to
meet evolving organizational needs.
- Ensure integrity, accuracy, and compliance of analytical data
in accordance with FDA, EMA, and other governmental regulatory
standards. Prepare and review CMC analytical sections of regulatory
submissions (NDA, NDS, MAA) and respond to regulatory requests for
information.
- Provide technical input during regulatory and corporate
inspections and audits.
- Completes work in a resourceful, self-sufficient manner and is
able to develop creative solutions to achieve business
goals.
- Provide technical guidance in analytical support to
manufacturing, CMO-QC laboratories, and to the Quality organization
to resolve test issues, conduct root-cause investigations, identify
and improve problematic methods, and drive innovation.
- Participate in and contributes to projects of diverse nature
across organizational units, such as: R&D and MT&D method
development, method validations, technology transfers, and post-NDA
process changes.
- Authors technical transfer protocols and ensure acquired
results are collected and documented according to cGMPs; Assists in
completion of close-out reports and appropriate Change
Controls.
- Maintains laboratory notebook, record keeping, and laboratory
safety in accordance with common industry GMPs and Lantheus'
procedures.
- Maintain and grow personal scientific, regulatory and
compendial expertise, and work with management to develop
organizational capabilities.
- Shows the ability and willingness to continually enhance
functional and technical expertise. Assesses own strengths/ needs
and learns from experience and feedback in order to continually
enhance the level of functional and technical expertise. Takes
action on developmental opportunities.
- Keeps abreast of science, literature developments within field,
program direction and current business issues.
- Actively promotes safety rules and awareness. Always
demonstrates good safety practices including the appropriate use of
protective equipment. Reports and takes initiative to correct
safety & environmental hazards.
- Actively demonstrates the Lantheus core values of Let people be
their best, Respect one another and act as one; Learn, adapt, and
win; Know someone's health is in our hands; Own the solution and
make it happen
Basic Qualifications
- D./M.S./B.S./B.A. in Chemistry, Pharmaceutics, Engineering,
Mathematics (or equivalent) with a deep understanding of the
technical aspects of analytical chemistry and pharmaceutical
process development, and a fundamental awareness of the roles of
other pharmaceutical functionalities (including Regulatory,
Compliance, Quality and Supply Chain).
- Requires a minimum of a Ph.D. degree and 2+ years relevant work
experience or a M.S. degree and 3+ years relevant work experience
or a B.S./B.A. degree and 6+ years relevant work
experience.
- Experience in Analytical Chemistry is highly preferred with
three (3) to five (5) years' experience in laboratory operations in
a pharmaceutical CMC environment and experienced in chromatography
data systems.
- Experience in common and radiopharmaceutical separation and
detection techniques (including HPLC-RC/UV, GC-FID, radioisotope
detectors) in QC or development labs, is strongly
preferred.
- Demonstrate working understanding of laboratory operations and
practices strong organizational and/or project management
skills.
- Strong analytical development and problem-solving
skills.
- Excellent verbal and written communication skills
Other Requirements
- Mastery of regulatory requirements for job and extended group
functions, expertise with regulatory requirements for
pharmaceutical development.
- Exceptional knowledge of scientific field of
specialization.
- Demonstrated skills in leading projects with an assigned
team.
- Able to properly handle and minimize exposure to potentially
hazardous chemical, radiological and or biological materials.
Required to follow all safety procedures and use personal and
protective equipment provided.
- Demonstrated ability to effectively communicate ideas and
information, both in oral and written form.
- May supervise targeted group(s) or functional areas.
- Travel (including international) is highly anticipated
Keywords: Lantheus, Leominster , Sr. Scientist CMC Analytical Development, Other , Billerica, Massachusetts
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