Description

This position is in the Biotherapeutics Pharmaceutical Research and Development Drug Product Design & Development group located in Chesterfield, MO and Andover, MA. The position requires collaborating with the Quality & Compliance organization to champion quality in lab operations to ensure compliance with standards and supports manager forums and new hire onboarding activities. Responsibilities include supplying packaging deliverables and support required for new drug product development, authoring required regulatory submission sections, addressing packaging/component related queries and contributing to the transfer of new drug products to commercial manufacturing sites.

In addition to these responsibilities, this role includes providing strategic direction for project teams, nurturing professional growth for team members, and ensuring accountability to drive successful execution across initiatives. This leader will foster a culture of continuous improvement and drive initiatives to enhance operational efficiency. The incumbent will be responsible for delivering the following activities associated with component and container closure system selection, qualification, development, as well as, design control packaging engineer deliverables for medical devices and combination products (MDCP). These activities include:

• Work on and supervise lab activities related to testing and investigation of MDCPs.
• Act as a Subject matter expert for laboratory operations to effectively manage the labs and to maintain compliance to ISO 13485
• Accountable for equipment calibration/qualification in accordance with Pfizer’s Quality Management System.
• Support electronic lab notebook super user and is accountable for the compliance of the lab notebooks in the department procedures and best practice.
• Develop and manage technical development needs of junior staff as appropriate.
• Assists project and group leads in developing goals and contributes to the reviews for other packaging engineers.

Position Responsibilities:

• Responsible for overseeing the day-to-day running of the laboratories.
• Provide supervision of the laboratory resources to meet DPDD objectives.
• Review testing work instructions, test protocols, lab notebooks and reports.
• Develop and expand the technical expertise and skills of the team to ensure SMEs have the right skills, knowledge, and tools to keep up with DPDD requirements and direction.
• Act as subject matter expert for laboratory operations to ensure effective management and control within the labs to maintain compliance to ISO 13485.
• Accountable for equipment calibrations / qualifications in accordance with Pfizer’s Quality Management System.
• Optimize processes, implement initiatives, and strategies to improve processes to maximize the quality and efficiency in support of Design Control projects.
• Implement a collaborative relationship between all DPDD business functions to provide effective support and input package engineering technical knowledge for project needs.
• Interact with and engage with multiple business functions e.g MT, EHS, Facilities, Quality and Global Workplace Solutions (GWS) on a regular basis to ensure alignment, understand trends and resolve issues effectively.
• Lead and manage cross-functional project teams aimed at harmonizing lab and business processes. Drive process alignment and compliance across functional teams, while overseeing a team of direct reports to ensure consistent execution and accountability.
• Work closely with local and global EHS teams to ensure compliance with all safety processes and protocols is maintained.
• Support lab notebook super user and accountable for the compliance of the lab notebooks in the department; Work with eLN superuser for continuous improvement of system and processes.
• Developing goals and contributes to the reviews for the supervised packaging engineers.

Organizational Relationships:

• Combination product development teams – device development leads, human factors SMEs, design engineers and device development scientists.
• Co-development team – drug product and device SMEs.
• Quality Assurance.
• GCMC (Regulatory).
• PGS – manufacturing sites and post launch device team.
• External designers and contract manufacturing organizations.

Qualifications:

• Bachelor's Degree in a appropriate Science & Engineering disciplines, e.g. Engineering (Packaging, Mechanical, Materials, Biomedical, Chemical, etc.), Chemistry, Biochemistry; or other related discipline with a minimum of 12 years OR 10+ years with a MBA/MS degree with relevant experience with Pharmaceutical Parenteral Packaging Development.
• PhD Degree with 8+ years of experience.
• Knowledge in parenteral packaging, component, and component testing equipment ,e.g. Instron, ZebraSci, Computrac, plunger movement chamber, etc.
• Experience working in a Good Manufacturing Practices (GMP) environment or equivalent, e.g. ISO 13485.
• Knowledge of packaging related regulatory standards and guidance.
• Capable of working independently with minimal supervision.
• High level of attention to technical details and accuracy.
• Being able to prioritize multiple responsibilities and to work on multiple tasks simultaneously.
• Demonstrated ability to work collaboratively in cross functional teams.
• Excellent communication (e.g. oral, written, presentation) and interpersonal relationship skills.
• Proficiency in general computer software such as word processing, spreadsheets, presentations.

Key Technical Skills:

• Knowledge of current US and global Regulations, US/EU/JP Compendia, ISO standards (e.g., ISO 13485, 11040, 10993, etc.), quality system regulations (Part 4) for combination products, Container Closure Systems for Packaging Human Drugs and Biologics FDA guidance document, and other applicable FDA and ICH guidance.
• Ability to interface with regulatory agencies to provide packaging rationale and justifications as needed.
• Understand component selection and device design activities.
• Possess and exercise breadth of packaging understanding within and outside Pfizer.
• Understand project management methodologies and capable of providing technical leadership for projects. Interact constructively with other partner lines and actively shares knowledge and expertise to define packaging strategy.

Physical/Mental Requirements

• Ability to work in a lab and office environment.

Non-Standard Work Schedule, Travel or Environment Requirements 

• Work-related travel will be 5 - 10% of the time (other Pfizer sites, vendors, conferences, etc.).

Other Job Details

• Relocation support available.
• Work Location Assignment: On Premise.