Pfizer Associate Oncology Operations in Pearl River, New York
The position performs manufacturing of commercial and clinical conjugate related products. Primary duties include performing all required complex manufacturing activities including production, investigation, equipment validation, writing SOPs, in compliance with company policy and regulations. Assist developing detailed plans and prioritize the routine tasks within the plan to achieve goals of incumbent's projects. Actively develop technical and operational leadership on all aspects of the manufacturing operations and contribute to the success of the department.
Multi-task all activities associated with manufacturing of commercial and clinical antibody drug conjugates including but not limited to operation, cleaning, investigation, change control, conducting training, etc. Heavy "hands-on" operations and irregular work schedules occasionally required. Function as a member of self-directed high performance team.
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 or modify Standard Operating procedures (SOPs) for commitment implementation or as related to new projects, facility and equipment changes. Evaluate and approve Preventive Maintenance Orders (PMOs). Initiate change controls related to new projects, facility and equipment changes, BR and PMO revision, etc.
Assist in problem solving efforts for manufacturing processes. Troubleshoot process issues, diagnose technical problems and identify short- and long-term solutions. Work closely with cross-functional groups to resolve system problems to minimize contamination and cost.
Conduct manufacturing deviation investigations and write investigation reports (MIRs). Identify root causes and corrective/preventive actions (CAPAs). Implement CAPAs commitments.
Compliance - 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.
Provide project team support as required by team leads.
BS in Chemical Engineering or related scientific discipline
On the job and "hands-on" training will be provided for drug substance intermediate, drug substance and drug product operation
Lean Six Sigma education or certification preferred but not required
High degree of manual labor. Heavy gowning requirements working in a clean room environment with cytotoxic materials. Must have ability to use respirator when necessary. Ability to perform entire work shift under these conditions.
Ability to apply general engineering techniques/principals.
Knowledge and ability to understand automated process control systems.
Ability to analyze operational process problems and implement appropriate corrective and preventative actions.
Effectively interact with team members within and across functions. Can articulate the issues and solutions to both team and to management. Ability to organize and present data to related team meetings or sr. management and poster presentations at external meetings, communicating effectively in both written and oral forms.
Ability to make timely and sound decisions.
Assimilates new knowledge skills, and job-related information that may vary in complexity, and applies them to work assignments in a timely manner.
Generate different creative or novel solutions to business processes. Evaluate the latest technology advances and apply to appropriate business problems.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional need for off hours work (evenings, weekends).
Aseptic/Personnel Safety gowning requirements.
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.
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.
Additional Offer Details:
Last Date to Apply for Job: August 5, 2017
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.