Drug Product Process Engineer, Gene Therapy Manufacturing Technical Services

ROLE SUMMARY

As a member of the Gene Therapy Manufacturing Technical Services Team located in Sanford, NC, the Drug Product Engineer is a technical process owner of assigned Drug Product unit operations and serves as a scientific and technical representative for process and equipment related projects.

During the initial phase this role will focus on supporting the Gene Therapy facility start-up, process transfers, clinical material production and process validation. Following execution of process validation the scope of work will include authoring of Biological License Agreement(BLA) leaflets , process performance monitoring, support for change controls and deviations as well as identification of process improvements.

ROLE RESPONSIBILITIES

• Authors process descriptions, process flow diagrams and risks assessments
• Designs technical and engineering studies, writes technical reports summarizing study results and generates necessary data to support change impact assessments during process transfers and investigations
• Provides process related on the floor support
• Supports change management and implementation for changes to the drug product manufacturing processes
• Identifies potential process improvements projects. Leads implementation of process improvements projects and supports compliance driven projects that require technical support.
• Supports process transfers the Sanford Gene Therapy facility.
• Authors and contributes to the Drug Product process validation plans, protocols and reports.
• Authors Biological License Agreement sections
• Benchmark and monitor process performance using statistical tools

QUALIFICATIONS

• MS or BSc degree in Bioprocessing, Chemical, Biomedical or other Engineering/Sciences related discipline is required.
• For MS degree- minimum of 3 years; for BSc degree minimum of 5 years of relevant biopharmaceutical experience
• An in-depth knowledge of Aseptic processing and filling unit Operations
• Large molecule (biologics) drug product process development and/or process transfer experience is required
• Experience in authoring technical studies protocols and reports is required
• Ability to focus on specific production processes with great attention to details
• Strong leadership, organizational planning and project management skills, in addition to technical knowledge is required to work with multi-disciplinary teams
• Excellent interpersonal effectiveness and communication skills (written and oral) are required in order to interface across management levels and departments.
• Must be self-motivated and work with minimum direction

Preferred

• Understanding of Quality by Design is desirable
• Basic knowledge of Delta V is a plus and statistical tools is a plus

PHYSICAL/MENTAL REQUIREMENTS

• Remains organized & 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

Schedule is primarily day shift, but at times it will be necessary to work according to the manufacturing shift schedules (1st, 2nd or 3rd shift) to support execution of batch records when manufacturing batches during a tech transfer.

• Last Date to Apply for Job: 10 /5/2020
• 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