Senior Manager
Company: Pfizer
Location: Pearl River
Posted on: January 27, 2023
Job Description:
Why Patients Need YouThis position is within the External
Laboratory and Reagent Management (ELRM) group within
High-throughput Clinical Immunoassays & Diagnostics (HCID) within
Vaccine Research and Development (VRD). The primary function of
HCID is to validate robust, high-quality, high-throughput
immunoassays and diagnostic assays and their compliant execution to
deliver high-quality clinical assay results for Pfizer's vaccine
clinical research programs.What You Will AchieveThis position will
have the responsibility to manage clinical assay projects with
external laboratories including academic institutions, government
laboratories, and contract laboratories. The role will oversee
technology transfer of assays, clinical sample testing, monitoring
of assay performance, assay investigations when needed, and provide
general vendor oversight.In addition, the incumbent should
demonstrate comprehensive industry knowledge in order to work
cross-functionally to identify and qualify new opportunities for
collaboration and outsourcing of Pfizer clinical sample testing
needs. The incumbent will be expected to maintain master testing
plans, secure appropriate resource requirements, and provide
financial guidance and oversight of the external laboratory budget
for multiple programs of moderate complexity. The incumbent must be
able to leverage technical expertise across own and related
disciplines to interpret and communicate laboratory results and
project status both verbally and in writing. The incumbent must
have a positive work ethic, strong interpersonal skills, and be
highly collaborative with groups both inside and outside of Pfizer
as they may need to lead by influence rather than direct
authority.This position operates with limited supervision. Work and
tasks managed are to be done in a compliant manner according to
relevant SOP guidelines and GCLP/GLP/GMP guidelines, when
required.How You Will Achieve It
- Serve as a point of contact for various functional groups to
manage Pfizer's clinical sample testing and Pfizer-associated
assays at external laboratories supporting VRD programs.
Responsibilities include transfer of biofunctional, ligand-binding,
serological, and diagnostic assays to external laboratories as well
as oversight of staff training, assay documentation, and scientific
and organizational leadership to the external laboratory
leadership.
- Maintain a 12-month master testing schedule and provide
financial guidance for outsourced activities.
- Routinely monitor assay performance at external
laboratories.
- Actively contribute to assay investigations and problem solving
that arise in routine and non-routine assay testing.
- Evaluate, critique, recommend, and qualify external
laboratories and/or their in-house assays for outsourcing of Pfizer
clinical sample testing. Ensure that assays performed at external
laboratories supporting Pfizer clinical studies are qualified or
validated (as appropriate) and assay-associated tasks performed at
external laboratories are done in a compliant fashion, in
accordance with prevailing SOPs, and GCLP/GLP/GMP regulations, as
appropriate.
- Leverage technical expertise across own and related disciplines
to interpret and present experimental results; provide scientific,
technical and management direction to external laboratory leaders
and managers.
- Actively monitor industry trends, models, and processes for
outsourcing and recommend improvements, enhancements, savings,
and/or synergies to senior leadership for approval.
- Manage and oversee the generation of contracts and agreements
with external laboratories, including, but not limited to, master
service agreements, quality agreements, and scope of work
documents.
- Help execute audits and manage productive collaborative
relationships with external laboratories.
- Independently perform all aspects of work to support clinical
and development studies with minimal support from direct
supervisor.
- Effectively communicate experimental designs, strategy, and
results verbally and in writing. Authors, reviews, and approves
standard operating procedures (SOPs) and technical reports.
- Satisfactorily complete all GCLP/GLP/GMP and safety training in
conformance with VRD & HCID requirements.
- Where applicable, perform job responsibilities in compliance
with GCLP/GLP/GMP and all other regulatory agency
requirements.
- Present experimental results at group and project
meetings.
- May manage one or more direct reports.
- Limited travel to visit external laboratories during the year
is required.QualificationsMust-Have
- PhD, Master's, or Bachelor's degree in microbiology,
immunology, virology, biochemistry, or related discipline with 3
years (PhD), 5 years(Master's) or 10 years (Bachelor's) relevant
experience.
- 3-5 years of Lab testing management
- Ability to write scientific reports
- Strong verbal and written communication skills.
- Ability to design experiments, analyze and interpret scientific
data.
- Training in a GCLP/GLP/GMP environment and other international
regulatory guidelines is preferred.
- Proficient in Microsoft Office 365 applications.
- The ability to effectively design and execute laboratory
experiments and communicate results both verbally and in
writing.Nice-to-Have
- Strong working knowledge of microbiology, immunology, vaccine
research and/or assay development.
- Experience in the execution of clinical testing in support of
clinical trials.
- Direct hands-on experience working in a regulated
(GCLP/GLP/GMP) environment is desired.
- Strong attention to detail and commitment to operational
excellence.
- Ability to work on multiple projects simultaneously.
- Familiarity with clinical trial execution, working with
external laboratories, budget management, and related
areas.PHYSICAL/MENTAL REQUIREMENTS
- Ability to perform work while standing/sitting.NON-STANDARD
WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- This position may require weekend work and evening work to meet
critical business timelines.
- This position will require occasional travel to scientific
meetings, between Pfizer sites, to external laboratories, and other
business-related travel.Relocation support availableWork Location
Assignment:On PremiseRelocation assistance may be available based
on business needs and/or eligibility.Pfizer requires all U.S. new
hires to be fully vaccinated for COVID-19 prior to the first date
of employment. As required by applicable law, Pfizer will consider
requests for Reasonable Accommodations.Sunshine ActPfizer reports
payments and other transfers of value to health care providers as
required by federal and state transparency laws and implementing
regulations. These laws and regulations require Pfizer to provide
government agencies with information such as a health care
provider's name, address and the type of payments or other value
received, generally for public disclosure. Subject to further legal
review and statutory or regulatory clarification, which Pfizer
intends to pursue, reimbursement of recruiting expenses for
licensed physicians may constitute a reportable transfer of value
under the federal transparency law commonly known as the Sunshine
Act. Therefore, if you are a licensed physician who incurs
recruiting expenses as a result of interviewing with Pfizer that we
pay or reimburse, your name, address and the amount of payments
made currently will be reported to the government. If you have
questions regarding this matter, please do not hesitate to contact
your Talent Acquisition representative.EEO & Employment
EligibilityPfizer is committed to equal opportunity in the terms
and conditions of employment for all employees and job applicants
without regard to race, color, religion, sex, sexual orientation,
age, gender identity or gender expression, national origin,
disability or veteran status. Pfizer also complies with all
applicable national, state and local laws governing
nondiscrimination in employment as well as work authorization and
employment eligibility verification requirements of the Immigration
and Nationality Act and IRCA. Pfizer is an E-Verify
employer.Continuous Imprv and Proj Mgmt
Keywords: Pfizer, New York , Senior Manager, Executive , Pearl River, New York
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