Manager, Process Engineering - Downstream, Gene Therapy Manufacturing Technical Services

ROLE SUMMARY

As a member of the Gene Therapy Manufacturing Technical Services Team the Downstream Senior Process Engineer will play a pivotal role in process validation, launch and commercial production of Gene Therapy Drug Substance manufactured in Sanford, NC. During the initial phase this role will focus on supporting the Gene Therapy facility start-up and process validation. Following execution of process validation the scope of work will include process performance monitoring, commercial operations support for change controls, process changes and deviations as well as identification of process improvements.

ROLE RESPONSIBILITIES

• Design technical and engineering studies in support of commercial process changes, author protocols, write technical reports summarizing study results
• Lead risks assessments
• Establish an effective Continuous Improvement feedback loop between Operations, Project teams and the downstream equipment vendor(s) to incorporate lessons learned
• Support change management and implementation for changes to the manufacturing processes and associated systems.
• Support for regulatory submissions and PAI readiness
• Mentor and train junior colleagues

BASIC QUALIFICATIONS

• Degree in Bioprocessing, Engineering, Molecular Biology or related discipline
• BS with a minimum of 5 years of experience in the pharmaceutical industry
• An in-depth knowledge of downstream purification unit operations including chromatography, UF/DF, and viral filtration
• Experience with Single Use Systems
• Strong leadership, organizational planning and project management skills, in addition to technical knowledge, is required to work with multi-disciplinary teams.
• Must be self-motivated and work with minimum direction
• Excellent interpersonal effectiveness and communication skills (written and oral) are required in order to interface across management levels and departments.

PREFERRED QUALIFICATIONS

• Knowledge of statistical tools (e.g. six sigma, process capability, control charting, etc.)
• Change management experience

PHYSICAL/MENTAL REQUIREMENTS

• No unique physical requirements

Mental:

- Remains organized and positive in ambiguous and fast-paced, rapidly changing environment

- Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure and in ambiguous situations

- Ability to process complex information and make recommendations with incomplete data set

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Ability to adjust work schedule to meet business needs - overtime, off shift, weekends.

Ability to travel- travel time may be up to 20% according to business needs.

• Last Date to Apply for Job: 9/18/2020

• Eligible for Employee Referral Bonus

• Eligible for Relocation package

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.

Engineering