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.
ROLE RESPONSIBILITIES
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.
QUALIFICATIONS
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.
PHYSICAL/MENTAL REQUIREMENTS
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.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.