Technology Transfer Lead, Pfizer Parenteral Center of Excellence
Company: Pfizer
Location: Lake Forest
Posted on: June 12, 2021
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Job Description:
ROLE SUMMARY Provides technical leadership and is a main point of contact
representing Pfizer Parenteral Center of Excellence (PCoE) with
Pfizer sites that manufacture parenteral injectables and external
CMOs (Contract Manufacturing Organizations). The role is involved
in the collaborative development of products for PCoE and works
directly to provide guidance for Pfizer and CMO groups that are
supporting PCoE PharmSci products. Focused on global product
development through commercial launch. This individual must be able to work in a collaborative
environment and must be able to effectively communicate to both
internal and external customers. To be successful, the position
must interface effectively with analytical, formulation,
microbiology, device, regulatory, operations, quality and other
essential functions. The role oversees and manages the tech
transfer process of sterile injectable (includes solutions,
lyophilized products)and other pharmaceutical dosage forms
(includes solutions, suspensions, emulsions, etc.) and must have a
fundamental understanding of cGMP, sterile operations, etc. The individual will be expected to provide detailed technical,
process understanding and expertise in support of complex technical
investigations, process troubleshooting, technical transfer, scale
up, as well as batch manufacturing
(demonstration/engineering/registration/process validation/initial
commercial batches). The individual will be instrumental in
facilitating project and technical ownership to PGS (Pfizer Global
Supply) prior to PV (Process Validation)/commercial batch
manufacturing. The individual will be expected to leverage collaboration across
multiple groups and competing priorities and should have extensive
understanding and experience dealing with large technical group of
engineers, scientist and technicians in large multi-product
contract manufacturing facilities. The role should be knowledgeable
of the documentation necessary for tech transfer of new products,
including tech transfer plans and risk assessments. The position resides in the GPPD (Global Parenteral Product
Development) organization and is responsible for Right First Time
(RFT) processes and knowledge management for the HBU portfolio as
part of global "codevelopment" project teams. Using principles of
Quality Risk Management (QRM) and sound science, the individual
will help facilitate the design and the development of
manufacturing processes at key milestones. ROLES & RESPONSIBILITIES Participate in cross-functional teams, within PCoE and
manufacturing sites, in the evaluation and implementation of novel
manufacturing technology and processes in commercial processes that
increase process robustness and promote a culture of innovation and
continuous improvement. Author, review, and/or approve site technology transfer
documents such as tech transfer plans, risk assessments, study
protocols, reports, batch records, sampling protocols, CAPAs,
change controls, standard operating and business procedures, policy
and instructions, etc. Facilitates the RFT risk assessment process by coordinating with
subject matter experts to assist in the generation of key content
to support the RFT and knowledge management processes for
projects. Prepare, distribute & present project and portfolio status
reports to project team members and management. Contribute to regulatory filings, as required, including
reviewing and authoring CTD sections and peer review of
submissions. Requires detailed knowledge of technology transfer and scale up.
Must be capable of assessing challenges and able to provide
technical support to resolve the technical issues during the
manufacturing. Able to trouble shoot/recommend the solutions to resolve the
technical issues with manufacturing equipment. Able to handle multiple projects simultaneously at different
CMOs and internal manufacturing sites. Responsible for working with
global R & D groups in optimizing/establishing process parameters
(with commercial processes in mind) within the design space to
evaluate/implement opportunities for process improvements. BASIC QUALIFICATIONS B.S. and 10 years, Ph.D. + 4 years, or M.S. + 6 years of
relevant pharmaceutical development and/or manufacturing
experience. Detail and planning oriented. PREFERRED QUALIFICATIONS Working knowledge of project management concepts and tools. Digital competency for process mapping tools/software (Visio,
etc.) and other process capability based tools/software (MiniTab,
etc.) PHYSICAL/MENTAL REQUIREMENTS Working environment mostly involves normal office
environment. Occasionally, laboratory and manufacturing working environment
where procedures, PPE (personal protective equipment) or protective
apparel/devices may be needed to address noise, dust, fumes, safety
hazards, etc. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT
REQUIREMENTS Colleague will work standard 1st shift work schedule, however,
additional hours outside of this (including weekends) are required
frequently to support conference calls with international groups
and oversight of engineering and exhibit batches. Other Job Details: #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. Engineering
Keywords: Pfizer, Lake Forest , Technology Transfer Lead, Pfizer Parenteral Center of Excellence, Other , Lake Forest, California
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