Senior Principal Scientist, Formulation and Process Development

ROLE SUMMARY

The Senior Principal Scientist in the GPPD (Global Parenteral Product Development) Formulation and Process Development team provides technical and team leadership in the collaborative development of products for PCOE (Parenteral Center of Excellence) and PSSM (PharmSci Small Molecule). This role provides leadership and direction in key decisions as it relates to new product and process development, including technology evaluations. Ensures a Quality by Design (QbD) approach is utilized by group personnel, with a focus on development of formulation and process, with emphasis on reliability and consistency. Staff consists of a cross-disciplinary group of highly skilled pharmaceutical scientists and engineers focused on global product development from post-concept through commercial launch. Responsible for creating an innovative space around product development from post-concept through commercial launch, especially with respect to advanced drug delivery and device technology. Also, works directly with external CDMO's as needed. Additionally, this individual prepares and reviews technical documents, including Product Development reports, Formulation development plans/reports, QbD protocols/reports, Co-Development plans, and general technical reports. Presents information at key forums for the business unit, both internally (i.e. technical reviews) and external (i.e. governance meetings).

The individual is expected to recruit, develop and motivate colleagues to successfully achieve group goals and colleague engagement. Additionally, this individual provides higher level
subject matter expertise in a consulting fashion within his/her own team as well as across GPPD/PCOE/PSSM. They are very technically capable, fully independent, and motivated to mentor other scientists. This individual must be able to work in a collaborative environment and must be able to effectively communicate to both internal and external customers. To be successful, the position must interface effectively with analytical, tech transfer, microbiology, regulatory, operations, quality and other departments, serving as the group's authority to senior leaders in these areas.

ROLE RESPONSIBILITIES

• Provide leadership and communicate clearly and concisely across multiple scientific and business functions, building effective relations with internal and external customers.
• Ensures sound drug product development and regulatory strategies are prepared for the design and development of robust, cost-effective sterile injectable formulations and manufacturing processes. Leverages Pfizer and external best practices when available. Leads team that is responsible for the Pharmaceutical Development section of regulatory dossiers for assigned projects.
• Provide day-to-day scientific and operational leadership for group
• Ensures that project teams have needed formulation/process development support and technologies. Achieves objectives through both formal channels and informal networks.
• Initiates and develops constructive relationships across organizations (PGS, Medical, Commercial, Business Development, Regulatory, Portfolio Management, external vendors, etc.) to ensure an effective integration of development strategies and activities across those interfaces and collaboratively assess new product and technology opportunities.
• Create an environment that attracts, develops, retains, and promotes diverse scientific talent through challenging assignments aimed at advancing staff capabilities and in the end strengthening Pfizer's ability to execute on product development and commercialization commitments.
• Able to recognize and address skill gaps and identify/create scientific and personal development opportunities. Coach/mentor direct reports and others on experimental approaches to solve complex problems and achieve improved scientific and operational excellence.
• Provide forecasted project resource requirements and ensure effective group infrastructure is in place (eg, best practices for routine work, cGMP compliance, colleague training, project tracking, report generation and review, etc.). Utilize awareness of portfolio priorities to assign resources and set priorities within group to ensure agreed project deliverables are met. Represent group/department at internal and external meetings.
• Assist in setting strategic and scientific direction for group and GPPD, maintaining an awareness of the portfolio, external regulatory environment and external technology evolution and innovation. Supports GPPD and PCOE initiatives and infrastructure by leading and/or serving on committees, work teams, etc., as needed. Translates GPPD/PCOE/PSSM strategy into focused objectives for successful execution.
• Establish and maintain group mastery of basic to complex methodology/technology to develop formulations and processes from simple to complex/differentiated drug products, including utilization of digital tools.
• Develops corrective action plans and implements such plans to resolve project issues and maintain business commitments.
• Supervise and lead BS/MS/PhD laboratory scientists, including handling general administration responsibilities within respective areas of responsibility and handle functional management issues related to direct reports: Merit Budget input, Performance Assessment/Rating input, Promotion recommendations, Position descriptions, Recognize and address skill gaps, including coaching on colleague Individual Development Plans, Scientific Advancement, Employee Health and Safety
• 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.

BASIC QUALIFICATIONS

• Must have a Ph.D. or Master's degree in pharmaceutics, chemistry, chemical engineering, or similar discipline
• MS. and 10 years of laboratory/technical experience and 2 or more years of direct management of formulation and process development personnel.
• Ph.D. and 4 years of laboratory/technical experience
• Strong written and oral communication skills are required.

PREFERRED QUALIFICATIONS

• Moderate experience and expertise in formulation and process development of complex drug products (eg, sterile injectable suspension/emulsion, nanoparticles, peptide, ophthalmic, etc. dosage forms) in the pharmaceutical or related industries.
• Prior demonstration of scientific leadership and cross-disciplinary problem solving and collaboration
• Track record of leadership for multiple development projects

PHYSICAL/MENTAL REQUIREMENTS

At times, role will require work in a laboratory or pilot plant environment in the presence of chemicals. Use of appropriate Personal Protective Equipment (PPE) is required. Occasional work within a potent compound laboratory - using isolator or other safety technology will also be necessary.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Must be able to participate in occasional video/teleconferences outside normal work hours in support of global projects/initiatives and PharmSci groups based in other global regions.
• Domestic and International travel may be required. Although travel should not exceed 10% of work days on average, more frequent travel may be required at times.

Other Job Details:

• Eligible for Employee Referral Bonus

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Sunshine Act

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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.

Research and Development

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