Principal Scientist II (ARD)
Company: Cambrex Corp.
Location: Durham
Posted on: October 8, 2024
Job Description:
Company InformationYou Matter to Cambrex. Cambrex is a leading
global contract development and manufacturing organization (CDMO)
that provides drug substance, drug product, and analytical services
across the entire drug lifecycle. With more than 40 years of
experience and a growing team of over 2,000 professionals servicing
global clients, Cambrex is a trusted partner in branded and generic
markets for API and dosage form development and manufacturing. Your
Work Matters.At Cambrex, we strive to build a culture where all
colleagues have the opportunity to:
- engage in work that matters to our customers and the patients
they serve
- learn new skills and enjoy new experiences in an engaging and
safe environment
- strengthen connections with coworkers and the communityWe're
committed to attracting and nurturing a passionate team of valued
professionals in our fast-paced and growing company. - We offer a
competitive benefits package that includes healthcare, life
insurance, planning for retirement, and more!Your Future
Matters.Known for our customer-focused scientific and manufacturing
excellence, as well as our strong commitment to quality and safety,
we offer a range of career and growth opportunities across our
global network of locations. Together with our customers, we aim to
improve the quality of life for patients around the world. Start a
career where You Matter by applying today! Job OverviewExecute
analytical methods and provide general analytical support, such as
release and stability testing of drug substances and drug products.
Able to organize routine work independently and to evaluate,
troubleshoot and interpret generated data. Demonstrated
understanding of method development and qualification / validation
principles.Provides leadership and mentoring across the analytical
team and to other functions. Leads and /or provides input to higher
level initiatives. Routinely and effectively interacts with clients
to discuss data and methods. Trains and mentors other employees.
Additionally, this role may research and implement new methods and
technologies to enhance operations.Efficiently plans and conducts
experiments with an increased degree of independence. Prepares
research summaries and reports. Experienced with a wide variety of
analyses and techniques. Understand principles of and uses safe
laboratory work practices. Interacts with clients and participates
in FDA and/or client audits.Maintains professional knowledge
through familiarity with scientific literature. Works on problems
of diverse scope. Ability to independently plan and schedule
experiments. Interprets results from experiments and plans follow
up experiments to achieve project objectives. Ability to organize
the routine work with minimum supervision. Properly evaluate and
interpret generated data. Ability to troubleshoot.Demonstrates
strong understanding of compliance, provides input in site policy
regarding compliance questions, ensures that client requests are
within the boundaries of compliance. Responsibilities
- Execute analytical methods for in-process control, release
testing and stability monitoring of bulk drug substances and drug
products under cGMP guidelinesIndependently develop and evaluate
methodologies, design and implement experiments.
- Able to apply prior knowledge to accurately interpret
structural data.
- Good understanding of the functional chemistry affecting
analytical technique
- Ability to help identify risks for regulatory compliance or
violation of site SOP
- Participates in experimental design, including development of
methods and testing requirements to demonstrate method
suitability.
- Maintains compliant records with little or no supervision
- Able to write technical documents with assistance
- Strong understanding and proficiency in use and maintenance of
instrumentation, equipment, and scientific methodologies necessary
to perform assigned tasks
- Routinely participates in compliance meetings to ensure that
client requests are within boundaries of compliance
- Proficient with a broad range of laboratory techniques and
actively investigate new technologies
- Attend and may participate in national and international
scientific meetings
- Independently plan, perform and analyze experimental results in
a timely manner
- Draft and execute validation protocols for analytical
methods
- Perform and review data analysis and draft reports for
analytical method development and validation
- Demonstrate ability to correctly analyze data/results and
interpret outcome of experiments and to propose appropriate
follow-up and supervision
- Identifies and troubleshoots analytical problems with
instrumentation, general chemistry, test methodology and samples
submitted
- Perform assigned tasks carefully, safely and on schedule
according to SOPs and supervisor instructions
- Sets up various instrumentation for testing according to
written test methods and with little to no supervision.
- As needed, troubleshoots laboratory instrumentation
- Leads a sample project with assistance
- May participate in client level meetings, with approval
- Routinely leads and develop other team members.
- May advise clients on site procedures.
- Routinely acts as a team /project lead supporting scheduling of
project tasks and deliverables
- Responsible for ensuring compliance with cGMP and other
regulatory guidelines.
- Analyze information for technical correctness and accuracy
- Compile, maintain, interpret and extrapolate data on results of
analysis and communicate these results to supervisor
- Perform routine laboratory procedures in a timely and efficient
manner
- Strong understanding of the use of analytical techniques to
characterize materials
- Participate cGMP activities
- Provides input on SOPs and client questions
- Ability to author and review key technical documents with
minimal RFT errors and can write new SOPs with manger
assistance
- Maintain laboratory equipment and supplies as directed
- May support peer-led laboratory investigations process with
assistance
- Maintain a clean and safe work-space
- Maintain laboratory notebook and/or computer files (i.e. LIMS)
according to standard, accepted practices
- Participate in group and project meetings as required
- May lead key operational excellence initiativesEnter project
hours promptly and update project status on appropriate tracking
and/or timekeeping systems
- Attend seminars as required
- Participate in and comply with all current safety, health and
environmental programs
- Shows initiative and interest in learning new techniques and
tests
- articipates in technical discussions and brainstorming
sessions
- Communicates issues or challenges to senior staff and/or
management
- May review test data acquired by others and witness others'
notebooks
- Assists with and may mentor others regarding writing technical
documentation such as OOS, atypical investigations, deviations and
CAPAs
- Assists with writings standard operating procedures (SOPs),
methods, qualification protocols and other standard documents as
directed
- Provides input on SOPs and client questions
- Effectively and routinely provides training.
- Actively participates in recruiting efforts
- Routinely prepares well written and organized development
reports
- Performs other related duties as assigned.
Qualifications/Skills--- Working knowledge of experimental design,
including chemistry supporting method development--- Good grasp of
advanced scientific/technical reading, writing and verbal
communication skills--- Regularly conceives and applies innovative,
technical solutions to a variety of problems--- Effective
independent researcher--- Can articulate and evaluate project
concepts and strategy--- Operates with substantial latitude for
independent actions and decisions relating to technical problems
and procedures--- Recognized as a technical resource in a related
area --- Expert in related technologies--- Demonstrates continued
development in a relevant area of CMC--- Working knowledge of
advanced laboratory techniques --- Working exposure to cross
functional techniques including organic chemistry. --- Subject
matter expert in one or more instruments (i.e. GC, LC, dissolution,
TGA/DSC)--- Able to comply to SOPs and have understanding of
regulatory compliance--- Working knowledge of scientific concepts,
principles and procedures--- Actively and positively engages with
team and supports process improvements--- Ability to read and
execute compendial methodologies--- Strong understanding of current
FDA and cGMP regulations--- Strong knowledge of chemistry and
scientific calculations--- Hands on experience in analytical
techniques such as HPLC, GC, etc--- Strong computer skills---
Ability to operate laboratory equipment and computers --- Ability
to take direction from experienced scientists and contributes in a
teamenvironment--- Ability to effectively train and mentor
others--- Ability to effective lead teams--- Strong problem-solving
skills--- Excellent attention to details--- Can repeat and follow
detailed scientific procedures--- Able to clearly present results
verbally in group meetings and in written progress reports---
Routinely and effectively presenting findings to clients--- Good
interpersonal skills and is willing to ask questions about
procedures and concepts--- Aptitude and willingness to gain more
skills and knowledge in support of GMP regulations--- Excellent
written and verbal communication skills--- Familiarity with
computer software such as Empower, ChemDraw, Microsoft Word,
PowerPoint, and Excel.--- Aptitude and willingness to gain more
skills & knowledge.--- Good attention to detail and good
problem-solving skills. Education, Experience & Licensing
RequirementsB.S./B.A. Chemistry with 14+ years of experience in
related industry or MS with10+ years related experience or PhD with
6+ years related experience Supervision Received: Works under
general supervision.Physical Demands, Work Environment, and
TravelPhysical DemandsThe physical demands described here are
representative of those that must be met by an employee to
successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions.While performing
the duties of this Job, the employee is regularly required to use
hands to finger, handle, or feel; reach with hands and arms; talk
or hear and smell. The employee is frequently required to sit. The
employee is occasionally required to stand; walk and stoop, The
employee must be able to regularly lift and/or move up to 10
pounds, and occasionally lift and/or move up to 25 pounds. Specific
vision abilities required. Environment and Protective EquipmentThe
work environment characteristics described here are representative
of those an employee encounters while performing the essential
functions of this job. Reasonable accommodations may be made to
enable individuals with disabilities to perform the essential
functions. While performing the duties of this Job, the employee is
occasionally exposed to moving mechanical parts and vibration. The
noise level in the work environment is usually very
quiet.Travel:Little to no expected travel time.All requirements are
subject to possible modifications to reasonably accommodate
individuals with disabilities. Cambrex Corporation is an Equal
Opportunity / Affirmative Action employer and will consider all
qualified applicants for employment without regard to race, color,
religion, sex (including pregnancy, sexual orientation, or gender
identity), ancestry, national origin, place of birth, age, marital
status, disability/handicap, genetic information, veteran status,
or other characteristics protected by federal, state, and/or local
law.
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Keywords: Cambrex Corp., Lynchburg , Principal Scientist II (ARD), Other , Durham, Virginia
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