Pfizer Technical Operations 3 in United States
The Technical Operations 3, Clinical Manufacturing role is responsible for the manufacturing of GLP and cGMP grade Phase I/II products in accordance with established SOPs, within a cGMP environment. They will also work with the Process Development Team on technology transfer for upstream and downstream processes. Additional responsibilities include significantly contributing to the overall operations of the pilot plant, including identifying and implementing improvement initiatives, in order to achieve production goals and timelines . Also responsible for staying current, regarding current Good Manufacturing Practices (cGMPs) guidelines, Good Laboratory Practices (GLPs), and e xhibiting best practices within manufacturing, safety, compliance, investigations, and procedures.
Manufactures research, pre-clinical (GLP) and clinical (GMP) grade rAAV vectors utilizing shaker flasks, WAVE bioreactors and stir tank bioreactors along with depth filtration, centrifugation, column chromatography, and TFF.
St rictly adheres to SOPs, GLP, and cGMP regulations, including GMP batch records, and accurately completes documentation associated with preclinical and clinical manufacturing.
Maintains areas and manufacturing documentation in compliance with SOPs, GLPs, and cGMPs.
Develops and revises GLP and GMP SOPs and master production records and solution batch records to ensure their compliance with cGMP's.
Performs routine maintenance and troubleshooting of equipment and processes.
Adheres to Company safety procedures and guidelines by practicing and promoting safe work habits.
Has thorough knowledge and skills in procedures, techniques, tools, materials and/or equipment needed for position. Has a wide range of technical skills and operational knowledge.
Proactively identifies and resolves potential problems and makes decisions that require choosing between multiple options to resolve.
Manages own time and professional development; accountable for own results. Prioritizes own work flow and may assist in prioritizing the work flow of less-experience colleagues.
Completes recurring assignments independently and selects the most appropriate method or approach to do so within prescribed limits of authority. Refers only new or unusual problems to supervisor.
- Associates' Degree in Biotechnology, Biology, Biochemistry, or related science discipline is required. Bachelors is preferred.
Basic Required Experience
Minimum of three (3) years' experience with Good Manufacturing Practice (GMP).
Good working knowledge of GLPs and regulatory compliance requirements in a cGMP environment.
Experience working with computerized system (bioreactors, chromatography systems, filtration units).
Understanding of scientific principles in order to problem solve and troubleshoot test results.
Ability to think critically and demonstrate troubleshooting and problem solving skills.
Preferred Skills and Abilities
The successful candidate will possess strong interpersonal, teamwork, and collaboration skills. In addition, possesses strong workload planning skills, organization, and attention to detail, and follow through. Problem-solving and trouble shooting skills are essential. Must have excellent written and verbal communication skills. Ability to prioritize and multi-task concurrent project demands. Strong computer skills in Microsoft Office required e.g. MS Word, MS Excel.
Physical/Mental Requirements (not all roles will have physical or mental requirements)
- Must be able to gown into cleanroom environment, must be able to pass vision and respiratory testing, and must be able to perform simple mathematical calculations including addition and multiplication.
Non-Standard Work Schedule
- 2nd Shift position - Monday nights thru Friday night 8 hours
Additional Offer Details
Last Date to Apply for Job: September, 12 2017
Eligible for Employee Referral Bonus
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.
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A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.