SCIENTIST / SENIOR SCIENTIST - GMP, HPLC
Company: PPD
Location: Boston
Posted on: May 16, 2022
Job Description:
JOB DESCRIPTIONThis position requires long-term eligibility to
work in the US without sponsorship.Please note: F-1 OPT Visas are
not considered long-term eligibility for this role.
PPD is a leading global contract research organization. At PPD we
are passionate, deliberate, and driven by our purpose - to improve
health.
PPD Laboratories offers the most comprehensive set of laboratory
services available in the industry and continues to deliver
innovative solutions to our clients through our collaborative
approach, including PPD Laboratories FSP. PPD Laboratories FSP is a
unique partnership that allows our clients to leverage the
experience of our PPD staff, while allowing you, the employee, to
gain direct experience working onsite at a pharmaceutical/
biopharmaceutical company, all while maintaining full-time
benefits/advantages of being a part of PPD.
As a Scientist/Senior Scientist, you will use state-of-the-art
technologies to support small molecule programs through analytical
method development/validation, clinical supply release and
stability sample analysis for both drug substance and drug product
material in a GMP environment at the client lab facility.
Additional responsibilities for the role on site at a major
pharmaceutical company:
- Perform cGMP analysis and data interpretation for various
techniques such as HPLC, GC, KF, TOC, IR and dissolution on small
molecules.
- Compile and summarize analytical raw data in various physical
and electronic report formats.
- Maintains accurate records of experiments and results in a
laboratory notebook and authors reports as assigned.
- Demonstrates knowledge of scientific principles and basic
understanding of applicable drug development regulations.
- Data entry and various administrative functions for laboratory
data systems.
- Maintain cGMP training compliance.
- May participate in regulatory agency audits and
inspections.
- May perform peer review of analytical data and results
At PPD we hire the best, develop ourselves and each other, and
recognize the power of being one team. It's not just talk; our
award-winning training programs speak for themselves.
Join PPD in our relentless pursuit of excellence - apply now!Job
Qualification
Education and Experience:
- Bachelor's degree in Chemistry, Analytical Chemistry,
Pharmaceutical Chemistry or equivalent and relevant formal academic
/ vocational qualification
- Previous experience that provides the knowledge, skills, and
abilities to perform the job (comparable to 2+ years) or equivalent
combination of education, training, and experience.
- Senior Scientist: Previous experience that provides the
knowledge, skills, and abilities to perform the job (comparable to
4+ years) or equivalent combination of education, training, and
experience.
- In some cases, an equivalency consisting of a combination of
appropriate education, training and/or directly related experience,
will be considered sufficient for an individual to meet the
requirements of the role.
- 2 years of GMP and HPLC experience
Preferred Experience:
- Waters Empower, SLIM data management, or IDBS Electronic Lab
Notebook (ELN) and/or electronic quality management system
experience preferred
Knowledge, Skills and Abilities:
- Knowledge of applicable regulatory authority, compendia and ICH
guidelines
- Ability to understand and independently apply GMPs and /or GLPs
to everyday work with regard to documentation and instrument
use
- Ability to utilize Microsoft Excel and Word to perform
tasks
- Ability to independently execute analytical methods
- Good written and oral communication skills
- Time management and project management skills
- Problem solving and troubleshooting abilities
- Ability to work in a collaborative work environment with a
team
Working Environment:PPD values the health and well-being of our
employees. We support and encourage individuals to create a healthy
and balanced environment where they can thrive. Below is listed the
working environment/requirements for this role:
- Able to communicate, receive, and understand information and
ideas with diverse groups of people in a comprehensible and
reasonable manner
- Able to work upright and stationary and/or standing for typical
working hours
- Able to lift and move objects up to 25 pounds
- Able to work in non-traditional work environments
- Able to use and learn standard office equipment and technology
with proficiency
- May have exposure to potentially hazardous elements typically
found in healthcare or laboratory environments
- Able to perform successfully under pressure while prioritizing
and handling multiple projects or activities
#LI-MR1PPDFSP
Diversity StatementPPD is proud to be an affirmative action
employer that values diversity as a strength and fosters an
environment of mutual respect. PPD is committed to providing equal
employment opportunities without regard to age, race, color,
pregnancy, national origin, religion, sex, gender identity, sexual
orientation, disability, veteran status or status within any other
protected group.COVID-19 Vaccination Update for U.S. Colleagues
- All U.S. colleagues are required to report vaccination status.
New hires will be asked to report vaccination status within the
first two weeks of employment.
- All U.S. new hires who are in the following job categories must
be fully vaccinated before their first day of employment or request
an accommodation: executive director level and above, client-facing
commercial, clinical research associates (CRAs), remote site
monitors-local (RSM-L) all CRA and RSM-L line managers,
clinic-based staff in early development services and accelerated
enrollment solutions, and FSP within analytical services division
roles. New hires will be asked to disclose vaccination status upon
first day of employment and are required to report vaccination
status within first two weeks of employment.
Keywords: PPD, Boston , SCIENTIST / SENIOR SCIENTIST - GMP, HPLC, Other , Boston, Massachusetts
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