Director, New Products Solid Oral Dosage Manufacturing Technology
Company: Diversity Inc
Location: Madison
Posted on: May 27, 2023
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Job Description:
Job Title: Director, New Products Solid Oral Dosage
Manufacturing Technology Company Name: Pfizer Location: Madison, WI
Position Type: Full Time Post Date: 05/12/2023 Expire Date:
06/11/2023 Job Categories: Biotechnology and Pharmaceutical,
Government and Policy, Healthcare, Practitioner and Technician,
Information Technology, Legal, Manufacturing and Production, Sales,
Quality Control, Research & Development, Medical Job Description
Director, New Products Solid Oral Dosage Manufacturing
Technology
**What You Will Achieve**
The primary purpose of the **Director, New Products Solid Oral
Dosage Manufacturing Technology** position is technical leadership
of PGS manufacturing technology for new products with SOD drug
product formulations, from Co-Design, through Co-Development to
Commercial Launch. Key accountabilities of the position
include:
+ Lead PGS implementation of novel, New Product driven SOD DP
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 technologies
+ Co-lead SOD Drug Product Co-Design with PSSM, providing PGS
perspective on optimal DP formulation/manufacturing technology
approaches, leveraging Co-Development and commercial manufacturing
experience
+ Partnership with PSSM on process design for:
+ Sustainable Medicines, integrating recommendations from the
NetZero 2040 program workstream
+ Lead Time, incorporating learnings and implementing
recommendations from PGS iFlow/Lead Time programs
+ Lead SOD DP 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
(Drug Product Design, Global Drug Product Manufacturing), Launch
Excellence and GT&E (Clinical Supply and Technical Partnership
Operations).
+ 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 OpUs
+ Provision of technical leadership / subject matter expertise on
SOD DP 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 Team
+ Technical assessment of potential Business Development
acquisitions
+ SOD network strategy development
+ Integration of New Product driven SOD DP manufacturing
technologies into the PGS NextGen Technology program
+ Lead SOD Drug Product Tier 5 Technology Reviews, represent
GT&E on Drug Product Steering Team (joint PGS/PSSM forum), PCMM
and other network teams
The Director, New Products Solid Oral Dosage Manufacturing
Technology position will lead matrix teams and be required to
develop effective relationships with key partners in Pharm Sci
Small Molecule (Drug Product Design, Global Drug Product
Manufacturing), 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 activity**
**How You Will Achieve It**
+ Strong familiarity and experience with small molecule drug
product manufacturing technologies, unit operations, manufacturing
facilities, and regulatory expectations/strategy
+ Excellent technical project and program management track record
in bringing multi-disciplinary process and technology solutions
through to commercial implementation and approval
+ Demonstrated track record of excellent matrix leadership skills
and delivery of multi-disciplinary objectives
+ Ability to effectively engage and interact with manufacturing
technology suppliers
+ Highly capable innovator and problem-solver, with knowledge of
and passion for Innovative & Six Sigma tools and methodologies
+ Proven ability to synthesize process/product-related knowledge,
reflecting it in a systematic way so that it can be leveraged by
customers and stakeholders
+ Comfortable in a dynamic environment with agility to change
course quickly as new data and insights emerge
+ Excellent listener and inclusive partner within Co-Development
and with key stakeholders in PGS and Pharmaceutical Sciences
**QUALIFICATIONS**
**Must-Have**
+ BSc, MSc, or PhD in a scientific/technical discipline of the life
sciences
+ 10+ years of experience in solid oral dosage form manufacturing
within the pharmaceutical industry, together with a comprehensive
understanding of SOD unit operations and manufacturing
equipment
+ Previous experience in introducing novel manufacturing
technologies into a commercial environment from technology
selection through to commercial implementation and regulatory
approval
+ Effective project management skill set and demonstrated record of
success in leading technical and multi-disciplinary matrix teams to
successful outcomes
+ Hands-on experience of drug regulations/regulatory processes and
quality/GMP/compliance systems of the pharmaceutical industry
+ Practitioner of the Six Sigma and continuous improvement suite of
tools
+ Candidate 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 impact
**PHYSICAL/MENTAL REQUIREMENTS**
Requires 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
REQUIREMENTS**
+ International travel (up to 20%)
+ Adaptation of schedule to work across different time zones
**Other Job Details**
+ **Last Date to Apply:** May 24, 2023
+ Eligible for relocation assistance: No
+ Work Location Assignment:Remote
The 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 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
\#LI-Remote #LI-PFE Share - Black Enterprise
A monthly magazine and annual conference for African American
entrepreneurs and business owners.Diversity Inc
The leading publication on diversity and business.Hispanic
Business
The only publication for Hispanic and Latino entrepreneurs and
business owners.MBE Magazine
A bi-monthly publication that serves a nationwide forum for
minority and women business owners, corporations and government
agencies concerned with minority enterprise development.Minority
Business Development Agency (MBDA)
The only federal agency dedicated to advancing the establishment
and growth of minority-owned firms in the United States.National
Minority Business Council (NMBC)
A non-profit organization that expands opportunities available to
small, minority and women business owners.
Keywords: Diversity Inc, Madison , Director, New Products Solid Oral Dosage Manufacturing Technology, IT / Software / Systems , Madison, Wisconsin
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