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You will be updated with latest job alerts via email$ 66500 - 110900
1 Vacancy
Youve just received life changing newscancer! The doctor recommends several rounds of chemotherapy. Unfortunately chemotherapy not only targets the cancerous cells but the healthy tissues as well. During chemotherapy treatments you experience fatigue immunosuppression to other diseases nausea/vomiting hair loss and other symptoms. What if there was a way to deliver that cytotoxic drug directly to the cancerous cells and not indiscriminately to healthy cells across the body significantly reducing the adverse effects observed with chemotherapy Pfizer is at the forefront of antibodydrug conjugates (ADCs) biotherapeutic development. ADCs attach a cytotoxic drug (monomethyl auristatin E or MMAE) directly to an antibody which is released upon uptake into the tumorexpressing cell killing it. This novel technology significantly minimizes the impact to healthy cells thus reducing the toxic effects observed in chemotherapy and being a far more effective way to treat patients and increase survivability to life altering diagnosis.
Everything we do every day is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and riskbased compliant quality culture is flexible innovative and customer oriented. Whether you are involved in development maintenance compliance or analysis through research programs your contribution will directly impact patients.
Quality Control activities associated with clinical and/or commercial product raw materials and validation. Key responsibilities are performing GMP tasks associated with maintaining compliant Quality Control and Stability laboratories; testing analyzing interpreting and trending results; and creating reviewing and approving documentation.
Individual should have knowledge of current Good Manufacturing Practices (cGMP) Laboratory Information Management System (LIMS) Microsoft Office applications specifically Word and Excel analytical techniques and instrumentation Lean Six Sigma concepts and Lean Labs.
In this role you will:
Acts safely and follows all EH&S safety requirements for site and QC laboratories.
Be recognized as a goto person or Subject Matter Expert for a specific subject area and are considered capable of supporting audits and investigations reviewing/approving technical content to ensure scientific merit and compliance to regulations and Pfizer policy and standards.
Excellent written and verbal communication skills
Ability to identify issues present complex problems with possible solutions and actively take a leadership role to resolve issues.
Ability to solve highly complex mathematical problems and situationdependent problems using convoluted information.
Ability to receive feedback from management and colleagues and take accountability for actions and personal development.
Aptitude for good decision making based on procedures guidance and experience.
Awareness to know their own limitations and seek senior scientist or management guidance when appropriate.
Desire to ensure correctness and accuracy in tasks and documentation.
Fitness of functioning as a team member and performing independent work with minor guidance
Willingness to use personal skills and knowledge to achieve individual and company goals and objectives.
Understanding of own area of function and knowledge of other cross functional areas
Able to create review and approve test method and/or equipment validation records with limited guidance/coaching.
Understands the importance of feedback and receives feedback well from management and other colleagues.
Makes good decisions based on knowledge of quality systems and technical experience.
Recognizes the impact of procedural changes that may impact future quality tasks and decisions.
Able to review working instructions for technical content within own subject area and reference to applicable GMPs and regulatory expectations.
Responsible for personal timelines and seeks advice if conflicts arise.
Interacts with business lines and shares information with team; capable of influencing and negotiating with business lines.
Ability to communicate effectively with good interpersonal skills.
Perform tasks associated with maintaining Good Manufacturing Practices (cGMP) compliant Quality Control and Stability laboratories.
Support routine testing and analysis of batch samples associated with vary modalities in a QC setting.
Follow Environment Health and Safety requirements for site and QC laboratories.
Perform complex mathematical problems and data analysis.
Support product transfers new product development regulatory queries cost improvement projects and Drug Product plant support for Cleaning Validation.
Operate within established HR policies and basic colleague relations guidelines.
Write Standard Operating Procedures (SOPs) technical reports project plans etc.
Applicant must have a bachelors degree with 0 years of experience; OR an associates degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience.
Demonstrated knowledge of manufacturing quality or engineering practices in the biotech or pharmaceutical industry
Aptitude for good decision making based on procedures guidance and experience.
Effective communication skills
Knowledge of Microsoft Office applications specifically Word and Excel
Excellent effective written and verbal communication and interpersonal skills
Ability to work in a team environment.
Bonus Points If You Have (Preferred Requirements)
Relevant experience in biotherapeutics (antibodies vaccines and gene therapy)
Experience with Laboratory Information Management System (LIMS)
PHYSICAL/MENTAL REQUIREMENTS
Ability to lift 30 lbs stand for 2 to 3 hours at a time sit for 2 to 3 hours at a time walk long distances and bend to obtain items from lower shelving/cabinets.
Intellectual capability to perform complex mathematical problems and perform complex data analysis.
NONSTANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
Work schedule is first shift 8:00 am to 4:30 pm) but can include weekdays and/or weekend days as appropriate for assigned tasks/activities. Minimal flexibility in work schedule to cover business needs. Minimal offshift work to ensure business needs are met.
Nonexistent to minimal travel.
Must be able to wear appropriate PPE (e.g. lab coat safety glasses nonporous shoes gloves etc.
Work Location Assignment: On Premise
OTHER JOB DETAILS
Relocation assistance may be available based on business needs and/or eligibility.
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 providers 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.
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 EVerify employer. This position requires permanent work authorization in the United States.
Required Experience:
Senior IC
Full-Time