Director, New Products API Manufacturing Technology

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

Job Description:

Pfizer Director, New Products API Manufacturing Technology in Lincoln , Nebraska 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, Lincoln , Director, New Products API Manufacturing Technology, Executive , Lincoln, Nebraska