The ADC Tech Services Sr Associate performs and manages technical activities, initiatives relating to process/analytical/cleaning validation, process monitoring, technical evaluations/investigations, change management and responses to regulatory queries. Drives the application of advanced technical process solutions in manufacturing and validation improvement, ensuring priorities align with customer needs, technology management objectives, company goals and government regulations. Oversees the transfer of technology from development to production within and/or between manufacturing sites.
The position also performs manufacturing of commercial and clinical ADC conjugate related products. Primary duties include performing all required complex manufacturing activities including production, investigation, change management, equipment qualification, process validation, writing SOPs, in compliance with company policy and regulations. Develop detailed project plans and prioritize the tasks within the plan to achieve goals. Effectively manage your own work to insure manufacturing, compliance and project deadlines are met. Perform other technical tasks as required to ensure GMP and Safety compliance.
- Resolve complex technical problems by evaluation of production processes and implementing remediation activities. Provide technical support in complex investigations and lead when necessary.
- Collaborate with Process Development groups during the development of new products to provide a commercial operations perspective. Communicate and participate in meetings with other plant personnel.
- Provide guidance to other departments on relevant compliance issues. Participate in internal, regulatory and corporate compliance audits. Maintain awareness within group of all Pfizer and regulatory compliance policies.
- Author and execute cleaning validations, process validations, method validation, technical/qualification studies, instrument qualifications and author reports.
- Compile process monitoring data from batch records, automated process control system and laboratory information management system. Analyze and report on process trends using statistical tools.
- Develop system expertise for automated systems, including the isolator-based vial filling and lyophilization line, and associated process control systems. Work with Engineering, Maintenance and OEMs to identify and implement system changes to improve equipment robustness. Drive the entire system improvement lifecycle from work order initiation, vendor service visits, change control initiation/coordination,equipment/programming changes and testing/qualification.
- Perform manufacturing of commercial and clinical batches in compliance with cGMP, Safety, and Environmental regulations. Meet the production demand. Ensure all Investigations and commitments are performed in a timely manner. Ensure all production equipment and systems are in compliance with cGMP.
- Create an environment that supports experimentation beyond self. Take appropriate risks to advance new concepts and methodologies that are moderately complex.
- Make decisions that may require developing new options to resolve complex problems. Make decisions guided by policies in non-standard situations.
Perform other technical tasks as required to ensure GMP and safety compliance. Promote cGMP compliance within the work place by following site cGMP procedures. Incorporate cGMP and regulatory compliance into all assigned projects scope and design.
- BS or MS in Chemistry, Engineering, or related scientific field.
- BS + 3 years or MS + 1 years relevant experience is desired.
Has experience in some or all of these areas:
Has strong technical knowledge in areas of biologic and small molecule manufacturing technologies. Keeps abreast of current developments and trends in areas of expertise.
Has experience applying statistical tools for the purpose of process monitoring. Has hands-on analytical instrumentation or process automation experience.
Has experience developing cleaning procedures and performing cleaning validations for pharmaceutical manufacturing.
Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis.
Use of personal protective equipment (coveralls, masks, respirators, gloves) is required. Products are cytotoxic.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional extended shift hours or weekend coverage. Occasional use of respirator with portable breathing apparatus. Aseptic gowning.
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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