Job Description

ROLE SUMMARY

The individual selected will be a key part of the Sterile Injectables Manufacturing Science and Technology Group which aims to deliver on process robustness and customer satisfaction through innovative solutions to manufacturing issues. In scope is full product life cycle support for aseptic drug products, including co-development, technical transfer, scale-up, process validation, registrations, ongoing troubleshooting and process improvements.

This position specifically involves the management of technical and development activities for product transfers to and from the Pfizer network and contract manufacturing organizations (CMOs), development / improvement of manufacturing processes for new and existing sterile injectables products across all business units, and manufacturing site support for critical investigations.

This position requires effective and direct communication skills, bold leadership and facilitation, and the ability to influence and integrate various colleagues from all levels of the organization.

ROLE RESPONSIBILITIES

As a MSAT Subject Matter Expert your responsibilities could include:

Technical

* Providing technical subject matter expertise and issue resolution for major/moderately complex investigations for aseptic sterile injectables, biologics and vaccines and assisting in completing all required documentation in a timely manner

* Participating in the Co-Development process, particularly in Late Stage Development/Phase 3 Clinical Supply to commercialization and continued product support

* Applies technical knowledge and skills to achieve goals of the department

* Preparing, reviewing, and may approve documents including protocols, reports, technical assessments, memos, study plans, and meeting minutes, as needed

* Collaborating with wet and analytical labs (e.g., Experimental Pilot Plant in Puurs) to execute exploratory or feasibility studies

Managerial

* Contributing to and occasionally managing moderately complex projects

* Maintaining project updates in IMEX VMB and other methods, as requested

* Good influencing skills and ability to work in a matrix organization to deliver results

* Comfortable with multifunctional and multi-cultural environments. Effective influencer, motivator and communicator

Interpersonal Effectiveness

* Highly respected colleague; able to influence team members across different organizations

* Strong analytical, strategic and interpersonal skills. Ability to synthesize concepts and requirements and effectively communicate them to all PGS stakeholders

* Interfacing with and influencing diverse customers including site groups from PGS (Ops, Technical Services, Quality) and network groups such as External Supply, QA, PharmSci, Procurement, and GCMC

Approach / Mindset

* Recognizes cross-functional impact in all decision-making; proactively reaches out to external stakeholder groups to gain alignment on cross-functional issues

* Able to identify root causes and drive to problem resolution; orientation towards action - anticipates problems and acts proactively to resolve; demonstrated initiative, drive, and creativity in problem solving

* Knows when to report or escalate risks and issues to leadership

* Use of DMAIC principals to drive resolution of issues and drive improvement of supplier performance

* Embraces Pfizer Purpose: Breakthroughs that change patients lives through the incorporation of the Bold Moves and Values and Behaviors

BASIC QUALIFICATIONS

* Bachelors with minimum of 7+ years in Engineering (Mechanical, Chemical, or Pharmaceutical preferred) Life Sciences Experience OR Masters with minimum of 5+ years.

* Sterile injectables/vaccines formulations and strong background in filling operations of Drug Product.

* Operations or Tech services experience.

* Ability to execute laboratory studies with nominal guidance and experience with aseptic techniques including working in biosafety cabinets, handling sterile liquid transfers, and sterile manipulation of drug substances for use in small- and interemediate-scale formulations.

* Knowledge of cGMP requirements and compliance.

* Excellent communication and technical writing skills.

* Ability to manage own time to meet agreed targets and develops plans for short-term and long-term activities.

* Ability to think creatively and find innovative solutions is a plus.

PREFERRED QUALIFICATIONS

* Experience in particle science/suspensions is an advantage.

* Experience with lyophilization is an advantage.

* Black Belt or Green Belt experience is an advantage.

* Working knowledge of Minitab or JMP preferred.

PHYSICAL/MENTAL REQUIREMENTS

Ability to be on the production floor during engineering/development batches.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Global travel may be required, typically 15-25%.

Adaptation of work schedule to accommodate meetings with colleagues in different time zones.

Other Job Details:

* Last Date to Apply: Feb. 2nd , 2021
* Eligible for Employee Referral Bonus
* Eligible for relocation

LI-PFE

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 providers 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.

Engineering

LI-PFE