Senior Manager External Supply (PGS Sourcing)

Company: Pfizer
Location: Groton
Posted on: November 19, 2021

Job Description:

Why Patients Need You Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them. What You Will Achieve As a Pfizer Global Supply (PGS) Manufacturing Coordinator (MC) and member of the of Drug Product Supply Sourcing (DPSS) team, you will play an integral part in managing the operational aspects of executing manufactures at PGS sites globally. This position provides the opportunity to collaborate closely with DPSS colleagues and partner lines to provide solutions to clinical drug product supply challenges using the internal PGS network and their vendors. High level responsibilities of the PGS MC include the following functions: * Developing and maintaining successful relationships with PGS partners * Facilitating GMP activities and logistics at PGS Sites with an emphasis on Co-Development projects * Leveraging the PGS network to obtain clinical and commercial drug product to support clinical trials It is your dedication that will make it possible for Pfizer's customers and patients to receive the medicines they need, when they need them. How You Will Achieve It Project Management / Contract Manufacturing * Manage multiple drug product outsourcing projects at PGS internal sites or with PGS external vendors to meet the needs of clinical teams. * Responsible for the smooth transfer of formulation design and process knowledge from Drug Product Design (DPD) to PGS partners for projects in the Co-Development process to enable successful manufacture. * Support ICH programs at PGS sites along with any other commercial readiness activities that are needed through validation. * Source Phase 4 marketed Pfizer products and clinical image of marketed products across all dosage form types (both small molecule and biologics). * Lead the preparation and approval of Technical or Supply Agreements with PGS sites to ensure internal alignment on manufacturing requirements. * Accountable for the logistical and GMP documentation aspects pertaining to drug product clinical supplies resulting from Co-Development batch manufacturing or commercial supply campaigns. * Track delivery of product lots and drive the timely resolution of any technical, logistical or quality/compliance issues that impact supply delivery and availability. * Oversee activities with Inventory Management, GMP Analytics and Quality Operations teams to ensure timely product receipt testing and disposition. * Coordinate SAP material movement through Pfizer logistics centers and Supply Points to supply Pfizer commercial products for use in clinical trials. * Support intake of drug product and API into Pfizer inventory systems including those acquired through business development and acquisition activities and drive other integration activities for drug product as appropriate. Customer Service * Provide timely updates on manufacturing schedules and estimated delivery dates to Supply Chain Leads (SCLs) and Pharm Sci Team Leads (PSTLs) to support clinical and development planning activities and forecasts. * Work with Procurement and Finance as needed to resolve issues regarding purchase orders or intercompany transfer costs for drug product from PGS sites and PGS contract vendors. * Travel both domestically and internationally (as required) to support key face to face project meetings and manufacturing oversight as needed. Technical Problem Solving * Collaborate with project teams and global Chemistry, Manufacturing and Controls (CMC) to determine proper commercial country presentations needed to drive sourcing strategies. * Ensure Technical Agreements for Co-Development projects or Supply Agreements for Phase 4 supplies accurately document the drug product manufacturing and analytical release process. * Review and approve GMP documentation relevant to clinical drug product supplies (e.g. DMIDs) with PGS supply partners. * Drive the timely resolution of technical and quality/compliance issues through partnership with Quality Assurance, CMC and PGS Operations/ Quality. Process and Metrics * Provide timing and cost estimates for proposed drug product sourcing and manufacturing campaigns. * Drive continuous improvement projects to enhance efficiencies and streamline processes. * Utilize internal digital systems to manage workflow and maintain and track metrics including delivery performance. * Contribute to the development and improvement on overall digital strategy to drive automation and compliance into our processes. * Navigate intercompany SAP routings and import/export process. Qualifications Must-Have * Bachelor's Degree and 7+ years of experience in the pharmaceutical industry or equivalent. * Work experience must include some of the following: drug product supply or pharmaceutical development, formulation development, sourcing and supplier management, project management, pharmaceutical manufacturing or other highly regulated industry. * Knowledge of industry practice for cGMP required; proven GMP experience is a plus. * Demonstrated skills in planning, organization, leading matrix teams and managing project deliverables and working with a high degree of autonomy. * Strong interpersonal, oral, and written communication skills and attention to detail. Nice-to-Have * Master's degree preferred disciplines include Biology, Chemistry, Pharmacy, Business or other relevant scientific area. * Experience across a range of dosage forms is highly desirable. * Additional certifications (Project Management) * Knowledge of Supply Chain discipline, including managing scientific project deliverables and interfacing with Pfizer Global Supply and external partners. 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. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Must be willing and able to travel both domestically and internationally (as required) to support key face-to-face project meetings and person in plant oversight, up to 20% at times. Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. 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. Manufacturing #LI-PFE

Keywords: Pfizer, Newton , Senior Manager External Supply (PGS Sourcing), Executive , Groton, Massachusetts