Director, New Products API Manufacturing Technology
Company: Pfizer Belgium
Location: Santa Fe
Posted on: May 17, 2023
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Job Description:
Pfizer Director, New Products API Manufacturing Technology in
Santa Fe , New Mexico What You Will AchieveThe primary purpose of
the Director, New Products API Manufacturing Technology position is
technical leadership of PGS API manufacturing technology for new
products, from Co-Design, through Co-Development to Commercial
Launch. Key accountabilities of the position include:Lead PGS
implementation of novel, New Product driven API manufacturing
technologies, endorsed by the Small Molecule Strategy Team, from
initial assessment through to commercial implementation, in
partnership with Pharm Sci Small Molecule (PSSM), Operating Units,
Procurement, Global Engineering and other GT&E functional
lines. Lead value assessment / replication opportunity reviews for
implemented technologiesCo-lead API Co-Design with PSSM, providing
PGS perspective on Chemical Route Nomination (CRN) and optimal
batch/continuous/hybrid manufacturing technology approaches,
leveraging Co-Development and commercial manufacturing
experiencePartnership with PSSM on process design for:Sustainable
Medicines, integrating recommendations from the NetZero 2040
program workstreamLead Time, incorporating learnings and
implementing recommendations from PGS iFlow/Lead Time programsLead
Starting Material Advisory Council (SMAC) with responsibility for
development of the regulatory starting material (RSM) strategy for
Co-Development and second-generation API programsLead API
manufacturing technology reviews for Co-Development* programs
conducted at PDT (Portfolio Delivery Team) and through RFT Risk
Assessments and Robustness Reviews, in partnership with PSSM and
Launch Excellence. Identification of future PGS-driven CI
opportunities (ranging from robustness/optimization to
second-generation process development)Lead the transition of
technical leadership, product knowledge management and future CI
project portfolio from Co-Development Teams to PGS Technical Teams,
in partnership with PSSM, Launch Excellence, other GT&E lines
(Analytical Technology, Clinical Supply, Technical Partnership
Operations and Technology Excellence) and Small Molecule & External
Supply OpUsProvision of technical leadership / subject matter
expertise on API manufacturing technology for key PGS workflows:New
product sourcing strategic decision-making (NP manufacturing/supply
chain - internal/external) through membership of the New Product
Sourcing TeamTechnical assessment of potential Business Development
acquisitionsIntegration of New Product driven API manufacturing
technologies into the PGS NextGen Technology programLead API Tier 5
Technology Reviews, represent GT&E on FAST Alignment and other
API network technology teamsThe Director, New Products API
Manufacturing Technology position will lead matrix teams and be
required to develop effective relationships with key partners in
Pharm Sci Small Molecule, Launch Excellence, other GT&E lines
(Analytical Technology, Clinical Supply, Global Engineering,
Manufacturing Intelligence, Technical Partnership Operations and
Technology Excellence), Small Molecule & External Supply OpU sites
and CMOs, Network Design & Performance, Procurement, Quality and
Regulatory CMC.*Note: this position is not directly involved in
individual Co-Development Team activityHow You Will Achieve
ItStrong familiarity and experience with small molecule API
manufacturing technologies, unit operations, manufacturing
facilities, and regulatory expectations/strategyExcellent technical
project and program management track record in bringing
multi-disciplinary process and technology solutions through to
commercial implementation and approvalDemonstrated track record of
excellent matrix leadership skills and delivery of
multi-disciplinary objectivesAbility to effectively engage and
interact with manufacturing technology suppliersHighly capable
innovator and problem-solver, with knowledge of and passion for
Innovative & Six Sigma tools and methodologiesProven ability to
synthesize process/product-related knowledge, reflecting it in a
systematic way so that it can be leveraged by customers and
stakeholdersComfortable in a dynamic environment with agility to
change course quickly as new data and insights emergeExcellent
listener and inclusive partner within Co-Development and with key
stakeholders in PGS and Pharmaceutical
SciencesQUALIFICATIONSMust-HaveBSc, MSc, or PhD in a
scientific/technical discipline of the life sciences10+ years of
experience in API manufacturing withinthe pharmaceutical industry,
together with a comprehensive understanding of API unit operations
and manufacturing equipmentPrevious experience in introducing novel
manufacturing technologies into a commercial environment from
technology selection through to commercial implementation and
regulatory approvalEffective project management skill set and
demonstrated record of success in leading technical and
multi-disciplinary matrix teams to successful outcomesHands-on
experience of drug regulations/regulatory processes and
quality/GMP/compliance systems of the pharmaceutical
industryPractitioner of the six sigma and continuous improvement
suite of toolsCandidate demonstrates a breadth of diverse
leadership experiences and capabilities including: the ability to
influence and collaborate with peers, develop and coach others,
oversee and guide the work of other colleagues to achieve
meaningful outcomes and create business impactPHYSICAL/MENTAL
REQUIREMENTSRequires the ability to lead detailed evaluations of
novel manufacturing technologies, requiring the understanding of
commercial manufacturing requirements and the ability to conduct
comprehensive technical reviews. Deliverables will be strategically
significant, and often under timeline pressure. Individual would
need the ability to travel to engage with PSSM teams, customer
sites (internal/CMOs), meet suppliers and participate in technology
trials as required.NON-STANDARD WORK SCHEDULE, TRAVEL OR
ENVIRONMENT REQUIREMENTSInternational travel (up to 20%)Adaptation
of schedule to work across different time zonesOther Job
DetailsLast Date to Apply: May 23, 2023Eligible for relocation
assistance: NoWork Location Assignment:RemoteThe annual base salary
for this position ranges from $144,900.00 to $241,500.00. In
addition, this position offers an annual bonus with a target of
20.0% of the base salary and eligibility to participate in our
share based long term incentive program. Benefits offered include a
retirement savings plan, paid vacation, holiday and personal days,
paid caregiver/parental and medical leave, and health benefits to
include medical, prescription drug, dental and vision coverage in
accordance with the terms and conditions of the applicable plans.
Salary range does not apply to the Tampa, FL location.Relocation
assistance may be available based on business needs and/or
eligibility.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.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.
Keywords: Pfizer Belgium, Santa Fe , Director, New Products API Manufacturing Technology, Executive , Santa Fe, New Mexico
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