Principal Scientist - Analytical Chemistry
Company: Pfizer
Location: Lake Forest
Posted on: June 6, 2021
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Job Description:
Role Summary: Our Pharmaceutical Sciences function supports Pfizer's early to
late stage portfolio translating new chemical entities into
commercial drug products. Pharmaceutical Sciences is a fully
integrated Chemistry, Manufacturing and Controls capability that
encompasses state of the art active pharmaceutical ingredient
synthesis and drug product design as well as cGMP manufacturing and
clinical trials supply chain. Operating within Parenteral center of
Excellence (PCOE), the Innovative Parenteral Product Development
(IPPD) group utilizes expertise in analytical chemistry, materials
science, formulation design and process development to deliver
innovative new parenteral medicines. We are seeking an analytical scientist to work in a team
environment (under supervision of a team leader) engaged in the
design, development, analysis and characterization of innovative
parenteral pharmaceutical dosage forms. You will predominantly be working in IPPD on novel drug product
and technology projects. You will be responsible for experimental
design, planning and execution of high quality work, interpretation
and reporting of data and communication to enable the design,
development, optimization, scale-up and technology transfer of
pharmaceutical dosage forms. Under the mentorship of subject matter
experts, your existing knowledge and experience will be enhanced
through engagement in a program of active learning and training
tailored to accelerate your contribution to the diverse business of
IPPD. Role Responsibilities Design and undertake high quality scientific experimentation to
further the analytical development of dosage forms for novel drug
candidates or product enhancement projects, which may include
formulation, characterization and biopharmaceutics assessment to
derive appropriate data. Role also encompasses documentation of
experiments in line with IPPD and site guidelines and authoring of
technical reports. Define analytical methodology to support the manufacture of
clinical supplies and commercial drug product based on development
and application of advanced analytical understanding and provide
scientific / technical support to colleagues in GMP manufacturing
facilities where appropriate. Contribute to the drafting of the relevant sections of the
Quality modules of regulatory documentation. Interpret scientific
data to derive clear conclusions and provide direction for future
work. Provide technical support to the Pharmaceutical Sciences
multidisciplinary team to facilitate and influence the development
of quality drug products. Develop and maintain a contemporary in-depth understanding of
the science, technology and regulation of parenteral pharmaceutical
dosage forms and apply this knowledge to development of assigned
drug candidates. Ensure safe working practices are maintained both in own and
others work. Based on expert knowledge, contribute / lead or develop
solutions for multi-faceted problems affecting drug
development. Provide scientific and strategic input at the interface with the
Research Units and Business Units to promote early stage projects
enabled through drug delivery technologies. Provide technical oversight and direction, to junior formulation
and analytical scientists. BASIC QUALIFICATIONS Ph.D. in analytical chemistry or allied scientific discipline
with 5+ years of work experience in an operational R&D role in
pharmaceutical, drug delivery (e.g. drug product development with
analytical focus; characterization of parenteral dosage forms and
support of regulatory submissions through cross functional
interactions); or Master's degree with 10+ years of relevant
experience. Recognized scientific knowledge base and technical ability in
requisite analytical tools (e.g. HPLC/UPLC, spectroscopic methods)
to understand parenteral products. Evidence of the ability to exercise sound scientific and
technical judgement Good experimentalist with experience and competence in a wide
range of lab technologies and unit operations in a manufacturing
environment, adherence to GMP and regulatory submissions. Effective oral and written communication Other Job Details Last Date to Apply for Job: June 9, 2021 Eligible for Relocation Package: Yes #LI-PFE Sunshine Act Pfizer 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 Eligibility Pfizer 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. Research and Development
Keywords: Pfizer, Lake Forest , Principal Scientist - Analytical Chemistry, Other , Lake Forest, California
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