Senior Associate, External Supply - Pfizer : Job Details

Why Patients Need You

Our medical advancements would not reach patients without the expertise and dedication of our pharmaceutical manufacturing team. We depend on a team of committed and nimble professionals who grasp the significance and impact of their role in achieving our mission. Patients need diligent colleagues like you, who are proud of their work and constantly strive to improve outcomes. Your efforts will ensure that patients and healthcare providers have timely access to the medicines they require.

What You Will Achieve

By collaborating with vendor partners and scientific lines, you will ensure the timely delivery of drug product and maintain high standards of quality and compliance. Your efforts in compiling and authoring technical reports, along with providing accurate timing and cost estimates, will support our drug product sourcing and manufacturing initiatives.

Through the implementation of informatics strategies and automation of processes, your work will enhance global procedures, leading to improved business practices. Your diligent monitoring of expenses and tracking of metrics will ensure financial accuracy and project accountability.

Ultimately, your unwavering commitment will ensure that patients and healthcare providers have timely access to the medicines they need, reflecting the profound impact of your role in achieving our mission.

How You Will Achieve It

Key Responsibilities:

* Handling Requests for Quotes (RFQ) and Requests for Information (RFI), vendor selection, and managing project schedules

* Facilitating GMP activities and logistics at vendor sites for PSSM programs

* Supporting Pfizer development compounds and comparator blinding through active participation in project teams

Project Management / Contract Manufacturing:

* Oversee the outsourcing programs for drug products to meet the needs of clinical teams.

* Assist in identifying suitable suppliers for Pfizer's drug product manufacturing campaigns by evaluating project requirements, vendor capabilities, available capacity, cost, and input from project teams during the quotation process.

* Ensure the seamless transfer of formulation design and process knowledge from Drug Product Design (DPD) to our vendor partners for successful manufacturing.

* Provide drug product manufacturing timelines and estimated delivery dates to Supply Chain Leads (SCLs) and Pharm Sci Team Leads (PSTLs) to support clinical and development planning. Offer updates and track drug supply manufacturing activities in response to demand requests and forecasts.

* Supervise the review and approval processes for GMP batch documentation.

* Manage the source-to-payment process for all outsourced manufacturing, including vendor selection, order placement, and invoice approvals.

* Coordinate the GMP manufacture of drug products at contract vendors.

* Work with GMP Analytics and Quality Operations teams to ensure timely product testing and disposition.

Customer Service

* Collaborate extensively with Global Clinical Supply (GCS) and Pharm Sci Small Molecule (PSSM) colleagues to define the clinical supply needs and to develop and implement project plans for outsourcing clinical supply deliverables across the PSSM clinical portfolio and all therapeutic areas.

* Engage with Procurement as necessary to address and resolve issues related to the procurement of drug product services from Contract Manufacturers and Pfizer Global Supply (PGS) sites.

* Provide real-time project status updates to internal clients and support teams, emphasizing the importance of strong written and verbal communication skills.

* Travel domestically and internationally, as required, to support supplier assessments, participate in critical face-to-face project meetings, and oversee manufacturing processes.

Technical Problem Solving

* Review and approve GMP documentation, including DMIDs, and coordinate the preparation and review of Master, Working, and Executed Batch Records with our vendor partners.

* Facilitate the prompt resolution of technical and quality/compliance issues at suppliers by partnering with scientific lines, Quality Assurance, and Regulatory CMC.

* Compile and author technical and investigational reports to identify, assess, and rectify quality issues, employing root cause analysis tools and methodologies.

* Monitor the delivery of product lots to clinical inventory or packaging sites, addressing any quality or logistics challenges that may occur during shipment.

Process and Metrics

* Provide accurate timing and cost estimates for proposed drug product sourcing and manufacturing initiatives.

* Assist teams in the development and enhancement of globalprocedures and business practices.

* Utilize internal IT systems to manage workflows as well as maintain and track metrics, including delivery performance.

* Implement the overall informatics strategy to drive automation and compliance into processes, including upgrades to planning and scheduling tools and the continued automation of workflows.

Qualifications

Must-Have

* Education- Bachelor's degree, preferred disciplines include Biology, Chemistry, Engineering, Pharmacy, Business or other relevant scientific or engineering area.

* 3+ years' experience in the pharmaceutical industry or equivalent required.

* Work experience must include a background in a regulated industry. Pharmaceutical and GMP experience is beneficial.

* Experience working with supply chain systems

* Experience in projects that require collaborative approaches, strong analytical skills & solid ability to understand business issues and processes

* Experience participating in matrix teams and managing complex deliverables within a team environment.

* Strong working knowledge of data management systems

* Excellent verbal and written communication skills in English, including a demonstrated ability to participate in teams with well-developed interpersonal skills.

Nice-to-Have

* Master's degree.

* Experience in a planning environment of a production plant, preferably in the pharmaceutical industry

* Knowledge of aseptic manufacturing processes

* Additional certifications (e.g. Six Sigma, Project Management) desirable.

PHYSICAL/MENTAL REQUIREMENTS

N/A

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 supplier meetings and person in plant oversight, up to 30% at times.

Other Job Details

* Last day to apply: November 29, 2024.

* Work Location Assignment: Hybrid.

* There's NO relocation support provided for this role.

The annual base salary for this position ranges from $74,900.00 to $124,800.00.* In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

* The annual base salary for this position in Tampa, FL ranges from $67,400.00 to $112,300.00.

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. This position requires permanent work authorization in the United States.

Manufacturing

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