(Senior) Principal Scientist, Impurities Subject Matter Expert
Company: United States Pharmacopeia
Location: Rockville
Posted on: May 14, 2022
Job Description:
This is a strategic scientific role within the Small Molecules
department (Global Science and Standards Division) responsible for
developing and advancing USP's impurities strategy for documentary
standards. The role is intended to support the development of
innovative approaches to USP's standards in order to better address
the complex challenges that impurities pose to pharmaceutical
quality. To achieve success, the incumbent will work
cross-functionally with USP internal staff, leadership, and our
expert volunteers and also engage with stakeholders to advocate for
and advance new standards approaches. Roles and
Responsibilities
- Collaboratively leads cross-functional teams working with USP
staff, USP volunteers, consultants, regulators, industry, and other
external stakeholders to develop and advance USPs impurity
strategy.
- Provides scientific direction and expert guidance on impurities
strategy execution to USP's Scientific and cross-functional
leadership.
- Advocates effectively both internally and externally to align
stakeholders and achieve consensus on approaches to impurities
standards.
- Represents USP at scientific conferences/meetings, outreach
visits and other events sponsored by USP and/or pharmaceutical
industry and regulatory agencies.
- Develops new monographs and revises existing monographs based
on expert evaluation and application of supporting data, monograph
tests, procedures, and acceptance criteria.
- Prepares manuscripts for publication by USP (e.g., stimuli
articles) or in peer-reviewed journals.
- Participates in the development and/or review of USP's
professional education course materials and may serve as an
instructor, as needed. Basic Qualifications
- Principal Scientist: Ph.D. in Chemistry, Biochemistry or allied
field with a minimum of 10 years of relevant experience; or MS with
12 years
- Senior Principal Scientist: Ph.D. in Chemistry, Biochemistry or
allied field with a minimum of 13 years of relevant experience; or
MS with 14 years Skills Sought
- Broad pharmaceutical industry experience in CMC development of
active pharmaceutical ingredients and drug products with
significant experience in the control of pharmaceutical
impurities.
- Expert knowledge on the establishment of control strategies for
all classes of impurities in pharmaceutical drug substances and
drug products, including mutagenic impurities.
- Strong knowledge of modern analytical techniques including
their development, validation, and application to the testing of
pharmaceuticals, such as HPLC. Preferred Qualifications
- Knowledge of global regulatory requirements and guidance (e.g.
FDA, ICH, etc.) relevant to pharmaceutical products
- Able to lead and coordinate high performing cross-functional
teams. Able to prioritize tasks and manage multiple projects
simultaneously.
- Able to distill large amounts of information into executable
strategies and workplans
- Able to adapt landscapes, strategies, and workplans based on
organizational/stakeholder needs and constraints
- Well-developed organizational, interpersonal communications,
negotiation, writing, and strong listening skills.
- Must be able to share technical information with non-technical
or non-scientific staff, and to communicate effectively with
representatives from pharmaceutical companies, government, and
academic institutions.
- Able to establish and nurture relationships with individuals of
varying backgrounds, cultures and learning styles.
- Able to operate independently yet understands when to escalate
issues and how to establish effective working relationships.
- Strong presentation and communication skills (written and
oral).
- Expertise in site-to-site transfer of methods and method
equivalency.
- Experience authoring reports for the CMC section of the CTD
used for IND or product applications for global submissions a
plus.
- Experience with advanced manufacturing technology (AMT),
process analytical technology (PAT) a plus.
- Experience with the development and/or commercialization of
complex generics products a plus.
- Expert knowledge of organic chemistry especially with regards
to formation of impurities a plus. . Supervisory Responsibilities
N/A USP offers an impressive benefits package, including:
- Generous paid time off - 15 paid holidays, 10 sick days and 15
vacation days per year to start
- An annual 401(k) contribution, beginning after 1 year of
service, of 10% of pay (base and bonus) every pay period that vests
immediately
- Comprehensive individual and family healthcare plans with
affordable premiums and low annual deductibles. The U.S.
Pharmacopeial Convention (USP) USP is an independent scientific
organization that collaborates with the world's top experts in
health and science to develop quality standards for medicines,
dietary supplements, and food ingredients. USP brings together more
than 1,100 talented professionals across five global locations to
deliver its mission to strengthen the supply of safe quality
medicines and supplements worldwide. USP is proud to be an equal
employment opportunity employer (EEOE) and affirmative action
employer. Employment selection and related decisions are made
without regard to sex, race, age, disability, religion, national
origin, color, veteran status, sexual orientation, gender identity
or any other protected class. We are committed to working with and
providing reasonable accommodation to individuals with
disabilities. USP does not accept unsolicited resumes from 3rd
party recruitment agencies and is not responsible for fees from
recruiters or other agencies except under specific written
agreement with USP. The following COVID-19 provisions will apply to
selected candidate(s) hired: As a condition of employment with
United States Pharmacopeial Convention's (USP) duty to provide and
maintain a workplace that is free of known hazards, all employees
and contingent staff hired after July 1st, 2021 are required to be
fully vaccinated unless a reasonable accommodation is approved.
Your recruiter will advise accordingly.
Keywords: United States Pharmacopeia, Rockville , (Senior) Principal Scientist, Impurities Subject Matter Expert, Other , Rockville, Maryland
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