Senior Analytical Biopharmaceutical Scientist
Company: Civica Rx
Location: Petersburg
Posted on: August 6, 2022
Job Description:
About Civica Over the past two decades, shortages of generic,
injectable medications critical to the lifesaving work of hospitals
in the United States have become commonplace. Approximately 200
medically necessary drugs are on the U.S. Food and Drug
Administration's shortage list. Manufacturing challenges and
predatory pricing are both the cause and result. Who suffers most?
Patients. Civica is a 501(c)(4) social welfare organization
established in 2018 by health systems and philanthropies to reduce
chronic generic drug shortages and related high prices in the
United States. Led by an experienced team of health care and
pharmaceutical industry leaders. Today, more than 50 health systems
have joined Civica. They represent over 1,200 hospitals and over 30
percent of all U.S. hospital beds. Civica has also begun to supply
the U.S. Department of Veteran's Affairs, the U.S. Department of
Defense, and the U.S. Strategic National Stockpile of essential
medicines. Civica is improving patient outcomes and reducing
healthcare costs by making strides to ensure patients and their
needs come first and that essential generic medications are
accessible and affordable. Since established, the Policy for the
Civica team has been Do What Is in the Best Interest of Patients.
Civica is launching a subsidiary to enter the Outpatient pharmacy
market partnering with Blue Cross Blue Shield with the goal of
reducing drug prices, especially high-cost generic drugs where
market forces are not working to control drug costs. To find out
more about how Civica's innovative model is directly impacting
patient care, click below to read a recent article from the New
England Journal of Medicine. Video Introduction to Civica: Position
Summary The Sr. Analytical Biopharmaceutical Scientist will be
expected to supervise, review, design, and assist in the execution
of biologic analytical testing and experiments to support the drug
development of biopharmaceuticals and biosimilar sterile injectable
pharmaceutical products. Under the direction of research and
development, you will review and approve protocols, analytical
data, method development, method validation reports, analytical
method transfer, technical reports, supervise contract testing, and
provide technical assessments in support of parenteral product
development. Additionally, this role will support cGMP quality and
regulatory requirements for BLA product submissions. This job
position may be performed remotely, in office, or by hybrid
approach. Essential Duties and Responsibilities
- Provide oversite of analytical method transfer, optimization,
and development/validation design. Analytical methods
development/validation and stability of drug substances, drug
product, excipients, and residual testing, using guidelines from
USP and ICH.
- Support method development/validation using HPLC, UPLC, GC
(direct inject/headspace) and ICP-MS as well as other analytical
equipment.
- Work with development partners to develop and own control
strategy and justification of specification rationale for biologics
products
- Support microbiological requirements through review,
development, and validation in support of product development as
required.
- Develop, author, and review protocols under which the methods
development, validation, transfer, and optimization, are
conducted.
- Supports Regulatory Affairs in the preparation and compilation
of the necessary documentation to be submitted in the product
regulatory filings to support BLA applications.
- Act as subject matter expert in discussions with FDA, defense
of control strategies, justification of specification, and
method
- Review of validation and stability data in support of the
method validation report and stability reports for BLA
submissions.
- Reviews, writes, or assists in SOPs, protocols, test methods
for analytical development.
- Review and support of USP Compendial testing and other
Compendial testing as required.
- Review and preparation of certificates of analysis and
stability reports.
- Investigates analytical methods failures by performing root
cause analysis techniques.
- Support investigations and atypical events, as well as
resulting corrective or preventive action implementation
- Works with and consults quality control, raw materials,
release, and stability labs to resolve analytical method
issues.
- Consults with scientific professionals and scientific
literature for problem solving assistance.
- Provides analytical testing support for manufacturing process
validation.
- Actively participates in Quality by Design for drug products
and Design Control for drug/device combination products.
- Provides guidance of routine sample processing and dosage form
analysis using a variety of analytical instrumentation.
- Support and supervise the work of contract development and
manufacturing organizations, from contract development to
technology transfer, process validation, and stability
testing.
- May assist in conducting peer reviews of other analytical data
from contract laboratories work in conjunction with quality
assurance.
- Performs other duties as required. Minimum Qualifications
(Knowledge, Skills, and Abilities)
- Bachelor's degree in Chemistry or related scientific field with
at least 5 years of biopharmaceutical product analytical chemistry
method development/method validation/routine testing experience.
cGMP experience preferred.
- Experience in analytical biological pharmaceutical
operations/cGMP environment and performing technology transfer is
preferred.
- Ability to identify and lead development partners and
consultants
- Experience with sterile/parenteral products is preferred but
not required.
- Knowledge of a wide range of pharmaceutical products and
processes is preferred.
- Knowledge of the product development process for
biologics/biosimilars.
- Complex problem solving with the ability to troubleshoot
technical issues and provide satisfactory resolution in a timely
manner.
- Ability to work with a variety of technical disciplines.
- Key to this position is the demonstrated ability to provide
technical leadership and teamwork in a cGMP environment across
functional and organizational boundaries
- Strong interpersonal and communication skills, both verbally
and written, at all levels within Civica and external partner
organizations.
- Ability to effectively collaborate with others to achieve team
goals and expectations.
- Effective time management and prioritization skills.
- Outstanding organization skills and attention to detail.
- Self-starter, mature, independent, and dependable.
- Ability to work in a fast-paced environment under pressure,
able to multi-task and obtain results.
- Ability to maintain high degree of confidentiality and use of
appropriate discretion and independent judgment. PI
Keywords: Civica Rx, Richmond , Senior Analytical Biopharmaceutical Scientist, Other , Petersburg, Virginia
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