Director, New Products Solid Oral Dosage Manufacturing Technology

Company: Diversity Inc
Location: Madison
Posted on: May 27, 2023

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