Sr. Scientist CMC Analytical Development
Company: Lantheus
Location: Billerica
Posted on: November 19, 2024
Job Description:
DescriptionLantheus 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.
This Northern Billerica based position reports to Senior Director
of Manufacturing Technology & Development (MT&D). This is a
small molecule & radiopharmaceutical focus process development role
supporting new and improved manufacturing processes, optimizations
in support of late phase pharmaceutical development, technology
transfer to Contract Manufacturing Organizations (CMO), and
authoring CMC non-clinical dossier sections.
These efforts support the economical, efficient, and safe
manufacture of radiolabeled precursors, drug substances, and/or
drug products. This position is to provide wide-ranging technical
support in order to identify, assess, and execute projects to
optimize existing and new processes, raw materials, and packaging
in radiopharmaceutical manufacturing and final product packaging.
Lead multi-functional teams to execute and deliver all aspects of
assigned projects, including specification, conceptual development,
selection, testing, and qualification. The qualified candidate must
be self-directed, be a great team player, and have excellent
communication skills to be considered for this role. Preference
given to those candidates who have experience in life sciences or
FDA regulated cGMP industries.
Essential Functions
- Work with minimal supervision to achieve personal objectives,
within Lantheus SOPs and governing regulations, while realigning to
meet evolving organizational needs.
- Identify opportunities to improve quality, efficiency, and
customer service through changes to product components, component
processing, and component inspection. Evaluate those opportunities
and present projects to management for approval to implement
changes.
- Prepare and review CMC manufacturing 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 process support to manufacturing,
CMO-manufacturing operations, 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 process
development, 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 record keeping and operations 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
Required Skills, Experience, and Education
- D./M.S./B.S./B.A. in Chemistry, Pharmaceutics, Engineering,
Mathematics (or related discipline) with a deep understanding of
the technical aspects of pharmaceutical unit operations, process
development, and a fundamental awareness of the roles of other
pharmaceutical functionalities (including Analytical, 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.
- Scientific knowledge and experience in radiopharmaceutical
process development and aseptic processes is highly preferred, with
three (3) to five (5) years' experience in operations in a
pharmaceutical CMC environment.
- Demonstrate working understanding of manufacturing operations
and practices strong organizational and/or project management
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, Portland , Sr. Scientist CMC Analytical Development, Other , Billerica, Maine
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