Senior Manager, Launch Excellence, Co

Company: Pfizer Belgium
Location: Honolulu
Posted on: May 25, 2023

Job Description:

Pfizer Senior Manager, Launch Excellence, Co in Honolulu , Hawaii Why Patients Need YouWhether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you will help bring medicines to the world even faster by imagining what's possible and taking action.What You Will AchieveThe Co-Development Lead (CDL) is responsible for serving as the primary PGS representative in developing and leading late-stage small-molecule product development ensuring PGS considerations are reflected in Co-Development project plans across all technologies (API/Analytical/Drug Product/Packaging) in partnership with Pharm Sci & PGS. The CDL role leads a PGS cross site and cross functional product focused team(s) and is responsible for PGS input into CMC strategy development and execution as well as PGS at risk spend elements of the overall CMC budget of late-stage clinical product development (Co-Development). For each product assigned, the candidate will drive PGS input to product strategy and provide this input across the co-development process. Including development, manufacturing and regulatory submission content to deliver the Quality Target Product Profile (QTPP), Validation and Launch strategies, knowledge management (including delivery of Process Understanding Plans (PUPs)), project timelines, key project milestones, and lessons learned.The candidate will build relationships with business line partners (Business Units, Global Product Development (GPD), Pfizer Global Supply (PGS) functions and manufacturing sites, and small molecule Pharm Sciences (PSSM)) to advocate for the strategies, plans and timelines of Co-Development Team(s).The candidate will also serve as the API Lead. In this role, the API Lead serves as the PGS subject matter expert for late-stage small-molecule API development, technical transfer, and manufacturing in partnership with Pharm Sci & PGS. The scope includes API commercial route nomination, development, validation, & initial launch supplies for the product.How You Will Achieve ItAs CDL:Represent PGS on the Co-Development Team (CDT) - led by Pharm Sci.As the PGS lead on the cross-functional matrix CDTs, work closely with PSSM, manufacturing sites, GMTs, and Business Unit, to evaluate technology and processes to transfer, validate, and submit CMC regulatory modules to health authorities, gain marketing approval, and launch new small-molecule products and in some cases support post approval major product enhancements of marketed products (e.g. new devices / formulations, line extensions).Provide PGS input into CMC strategy development, execution, and CMC budget.Serve as PGS point of contact to enable delivery of clinical supply plan for pivotal / Phase 3 studies.Provide PGS input into communications and alignment with key stakeholders, including in escalation of major changes and issues, project risks and opportunities.Provide PGS input into decision making in environment of competing priorities and varying levels of ambiguity.Partner with Pharm Sci Team Leader (PSTL) to create highly empowered and cohesive team(s) that can rally behind a compelling vision.Represent PGS on Joint Alliance Teams as needed (i.e. Joint Development Team, Joint Supply Chain Team, Joint Steering Team). Lead Alliance Joint Manufacturing Committee as neededLead key strategic projects / initiatives with ambiguous scope to enable Pfizer Purpose Blueprint and deliver value to organization, as neededServe as the interface with small molecule API groups including Chemical R&D (CRD) and Analytical R&D in Pharm Sci. In PGS they interface with New Products Value Stream in Ringaskiddy, Ireland, SM OpU, External Supply OpU, GTE, the wider Launch Excellence group, and other above site groups.Provide API technical project management for the development, technology transfer and commercialization of API and strategic/continuous improvement input to the product line Co-Development work processes.Represent PGS on the CDT, co-leading Co-Development API sub teams to develop Co-Development plans, co-design, RFT risk assessments, process understanding plans (PUP), lifecycle planning, and other key activities as part of Co-Development.QualificationsMust-HaveBS degree chemical engineering, chemistry, or other science-related field.10 years in production, engineering or process development (depending on degree).Demonstrated ability to effectively lead matrix teams; ensuring successful completion of major programs / projects as part of a team and/or project leadership role. Experience leading highly accelerated or high complexity projects.Demonstrated ability to interact effectively with colleagues at all levels of the organization, including senior internal and/or external personnel on matters often requiring coordination between organizations; able to build effective relationships and influence stakeholders at all levels of the organization.Able to develop solutions to complex problems using ingenuity, innovation, creativity, and leadership skills.Extensive technical and industry-specific expertise in drug development and/or manufacturing. Specific experience in small-molecule products area strongly preferred.Understanding of process of developing small-molecule drugs and CMC requirements.Flexible and adaptable to changing priorities and timelines (acceleration/deceleration), meeting deadlines, and working well under pressure.Comfortable working independently on high complexity assignments. Adept at developing processes necessary to accomplish goals. Simplifies complex processes. Skilled at organizing people and activities. Demonstrated ability to identify opportunities for synergy and integration. See and understand broader trends (organizational, run the business, improve the business) and come up with proactive solutions,Effective written and verbal communication skills. Clearly and concisely summarize complex issues, key outcomes, and importance to the audience, including senior leaders; able to work with different cultures.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.Nice-to-HaveExperience with API development & scale-up of small-molecule products.Experience with technical transfer of small-molecule products.Experience with co-development process for new small-molecule products.Experience with Pfizer budget processes, including managing project budgets (expense spending and FTEs).Understanding of Business Development processes.Physical/Mental RequirementsSignificant time on laptop & telecons (remote with global teams)Non-Standard Work Schedule, Travel or Environment RequirementsWork Location Assignment: FlexibleOther Job Details

• Last Date to Apply: May 30, 2023Relocation 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, Honolulu , Senior Manager, Launch Excellence, Co, Executive , Honolulu, Hawaii