Scientist, Analytical Development
Company: Disability Solutions
Location: San Diego
Posted on: April 19, 2024
Job Description:
Scientist, Analytical DevelopmentPosition Summary:Catalent
Pharma Solutions in San Diego, CA is hiring a Scientist in
Analytical Development.-- An individual at the level of Scientist,
Analytical Development will be expected to either lead projects
independently or build a team focused on the development of
analytical methods for small molecule, peptide drug products and
amorphous intermediates. This individual may be required to have
direct reports depending on growth and ability. The focus of this
role will be HPLC/UPLC-UV stability-indicating methods using
various separation chemistries including but not limited to
reversed phase, ion-exchange, and chiral.--In addition, the
individual may be responsible for overseeing development of assay,
dissolution, water content, and physical characterization methods
for oral and injectable drug products. The Scientist, Analytical
Development will be required to assist QC/QA in investigations as
an SME. All duties will be performed in compliance with company
standard operating procedures (SOPs) and GMP (Good Manufacturing
Practices) regulations, as appropriate.This position is
Monday-Friday, 1st shift (day shift) with flexibility. Catalent is
a global, high-growth, public company and a leading partner for the
pharmaceutical industry in the development and manufacturing of new
treatments for patients worldwide. Your talents, ideas, and passion
are essential to our mission: to help people live better, healthier
lives.--Catalent Pharma Solutions in San Diego is a premier
pharmaceutical chemistry development and manufacturing organization
supporting the pharmaceutical and biotechnology industries. We
focus on bringing client drug compounds from discovery to the
clinic with services that include analytical development,
pre-formulation testing, formulation development, GMP manufacturing
and stability storage and testing as well as Clinical Supply
Services.-- At Catalent San Diego, we recruit and develop
exceptional individuals with a passion for science and
determination to excel. We offer a technically challenging and
stimulating environment and the opportunity to learn from the best.
Catalent is committed to a Patient First culture through excellence
in quality and--compliance, and to the safety of every patient,
consumer, and Catalent employee.--The Role:
- Develop stability-indicating methods for peptide and small
molecule API (Active Pharmaceutical Ingredient), amorphous
intermediates, and drug products from scratch. Develop cleaning
verification methods.
- Perform and train others on a variety of analytical techniques
including, but not necessarily limited to: analytical balances, pH
meters, high performance liquid chromatography (HPLC/UPLC), UV/Vis
spectroscopy, GC (gas chromatography), USP dissolution testing
apparatus, moisture analysis by Karl Fischer, disintegration, Pion
--diss, PXRD (X-ray diffraction), DSC (Differential scanning
calorimetry), FT-IR (infrared spectroscopy), TGA
(thermogravimetric), and SEM (scanning electron microscopy),
hardness, and friability testing.
- Troubleshoot and optimize analytical methods for
characterization of drug products and intermediates.
- Clear and accurate record keeping in laboratory notebooks and
secondary review of other colleagues' work for scientific accuracy
and compliance.
- Responsible for transfer of analytical methods to other sites
as required. Collaboration with other departments to troubleshoot
technical issues.
- Communicate results both internally and externally through oral
and written updates and formal reports as necessary.-- Organize
meetings and monitor all client interactions independently.--
Supervisor will be notified if their assistance is needed.
- Assist in the creation and/or revision of new department-wide
and site-wide procedures and company SOPs.--Collaboration with
Quality Assurance and Quality Control on analytical method
validation and compliance issues.
- Individuals will stay abreast of current scientific
technologies to maintain the state-of-the-art nature of Catalent's
services. Individuals will proactively communicate strategy to
clients and draft addendums to contracts and write and provide
review of new proposals and change orders, as
appropriate.--Individuals will support the business aspects of
their position by taking responsibility for the execution and
billing communication for all work proposals under their
supervision.
- Hire, train, and supervise analytical group members as
necessary.-- Develop junior personnel for advancement within the
team. Suggest and lead continuous improvement projects.----
- Other duties as assigned.The Candidate:
- A PhD (Doctorate) is required in chemistry with a minimum of 6+
months of industry experience. 16 course credits related to
analytical chemistry and thesis work in the interaction between
lipids and biological species can be substituted for 6 months of
experience.
- Applicable industry experience entails: analytical development
and method development with instrumentation including, but not
necessarily limited to: analytical balances, pH meters, high
performance liquid chromatography (HPLC/UPLC - reverse-phase, ion,
and chiral), UV/Vis spectroscopy, GC (gas chromatography), USP
dissolution testing apparatus, moisture analysis by Karl Fischer,
disintegration, Pion --diss, PXRD (X-ray diffraction), DSC
(Differential scanning calorimetry), FT-IR (infrared spectroscopy),
TGA (thermogravimetric), and SEM (scanning electron microscopy),
hardness, and friability testing.
- Demonstrable leadership experience at Catalent (including but
not limited to participation in Catalent-sponsored leadership
programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may
be considered in place of external experience.
- Physical Requirements: On an average 8-hour day this position
requires the ability to walk, sit and stand, use hands to handle or
feel, reach with hands and arms at or above shoulder height and
below waist height, climb or balance, stoop, kneel, crouch, or
crawl; talk and hear, smell and lift up to 25 pounds. Specific
vision requirements including reading of written documents, visual
inspection of materials and use of computer monitor screen
frequently.Pay:
- The anticipated starting salary range for this role in San
Diego, CA is $96,762 to $110,160 annually. The final salary offered
to a successful candidate may vary, and will be dependent on
several factors that may include but are not limited to: the type
and length of experience within the job, type and length of
experience within the industry, skillset, education, business
needs, etc.-- Catalent is a multi-state employer, and this salary
range may not reflect positions that work in other states.Why you
should join Catalent:
- Awesome employee activities:-- Movie Day, Monthly Birthday
Celebrations, Friday Bagel Breakfast, On-site Fitness Center with
machines, on-site yoga and HIIT classes, Sponsored Sports Teams,
and several other company-sponsored events that encourages positive
employee comradery, which contributes to effectively building
positive employee relationships, overall creating a positive work
environment.
- Environmentally friendly green initiatives with on-site
practices as well as regularly participating in Beach Clean-up
activities for community engagement.
- Defined career path and annual performance review and feedback
process. Potential for career growth on an expanding team within an
organization dedicated to preserving and bettering lives. --
- Several Employee Resource Groups focusing on Diversity and
Inclusion.
- Competitive salary with bonus potential. Generous 401K
match--and Paid Time Off accrual. Medical, dental and vision
benefits effective day one of employment.--
- 152 hours of PTO + 10 paid holidays.
- Positive and fast-paced working environment focusing on
continually improving processes to remain innovative and
dynamic.
- Tuition Reimbursement--- Let us help you finish your degree or
earn a new one!
- GymPass program to promote overall physical wellness.
- Perkspot - offers exclusive or private discounts from
approximately 900+ merchants in a wide array of categories.Catalent
offers rewarding opportunities to further your career!-- Join the
global drug development and delivery leader and help us bring over
7,000 life-saving and life-enhancing products to patients around
the world. Catalent is an exciting and growing international
company where employees work directly with pharma, biopharma and
consumer health companies of all sizes to advance new medicines
from early development to clinical trials and to the market.
Catalent produces more than 70 billion doses per year, and each one
will be used by someone who is counting on us. Join us in making a
difference.--Catalent is committed to the health and safety of its
employees, visitors and the customers and patients we serve. As a
result of the global pandemic, we have modified many of our
recruitment and on-boarding processes to maintain everyone's
safety. The Human Resources teams will communicate all necessary
safety processes and procedures throughout each
stage.------personal initiative. dynamic pace. meaningful
work.Visit to explore career opportunities.Catalent is an Equal
Opportunity Employer, including disability and veterans.If you
require reasonable accommodation for any part of the application or
hiring process due to a disability, you may submit your request by
sending an email, and confirming your request for an accommodation
and include the job number, title and location to . This option is
reserved for individuals who require accommodation due to a
disability. Information received will be processed by a U.S.
Catalent employee and then routed to a local recruiter who will
provide assistance to ensure appropriate consideration in the
application or hiring process.--------Notice to Agency and Search
Firm Representatives: Catalent Pharma Solutions (Catalent) is not
accepting unsolicited resumes from agencies and/or search firms for
this job posting. Resumes submitted to any Catalent employee by a
third party agency and/or search firm without a valid written &
signed search agreement, will become the sole property of Catalent.
No fee will be paid if a candidate is hired for this position as a
result of an unsolicited agency or search firm referral. Thank
you.Important Security Notice to U.S. Job Seekers:Catalent NEVER
asks candidates to provide any type of payment, bank details,
photocopies of identification, social security number or other
highly sensitive personal information during the offer process, and
we NEVER do so via email or social media. If you receive any such
request, DO NOT respond- it is a fraudulent request. Please forward
such requests to spam@catalent.com for us to investigate with local
authorities.California Job Seekers can find our California Job
Applicant Notice .
Keywords: Disability Solutions, Escondido , Scientist, Analytical Development, Other , San Diego, California
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