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Product Technology Laboratory Manager

Pfizer


Location:
St. Louis, MO
Date:
11/28/2017
2017-11-282017-12-29
Pfizer
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Job Details

**ROLE SUMMARY**



This position is to manage the sites Product Technology's laboratory who's primary role is to evaluate defect samples through the use of sound, safe and justifiable scientific methods. The position will require that the staff utilize cGMP's in its daily activities such that samples are tracked, tested/evaluated and technical memo's or reports are written and supplied to the site Quality, Technology and Manufacturing groups







**ROLE RESPONSIBILITIES**







+ Manage a Combination Product laboratory to comply with cGMP's



+ Ensure staffing levels are adequate to support test requirements



+ Ensure laboroatory equipment are in compliance with Pfizer requirements and are maintained by the lab staff



+ Manage an appropriate documentation system to comply with Pfizer standards and cGMP's



+ Manage sample control through utilization of a system to ensure all samples are logged in and stored in a controlled manner



+ Manage the laboratory's staff to use appropriate SOP's and risk assessment files in the testing/evaluation of samples



+ Manage the laboroatory and staff to meet all Pfizer/site Safety standards



+ Manage the laboratory staff to evaluate Complaint, Manufacturing and autoinjector defect samples. Ensure that the staff creates thorough and comprehensive evaluation reports with concise summaries explaining the lab's findings



+ Manage the laboratory to create Inspection Qualification kits, Defect Limit samples and Equipment Challenge samples using appropriate materials and documentation practices



+ Manage the staff to create technical reports



+ Review and approve laboratory memo's and technical reports







**QUALIFICATIONS**







+ Bachelors Degree in Biomedical Engineering or Mechanical Engineering preferred with 3 - 5 years experience in the Pharmaceutical Combination Products or Device industries.







Required:



Conceptual design skills



Proficiency in design software (preferably Solidworks) and other general computer software such as word processing, spreadsheets, presentations, project planning etc.



Strong mathematical, analytical, and reasoning skills



Strong creativity and innovation skills



Strong research skills



Strong organizational skills



Being able to prioritize multiple responsibilities and to work on multiple tasks simultaneously



Responds to requests for service and assistance with professionalism, courtesy, and confidence



Strong in team work



Capable of working independently with minimal supervision



Strong oral communication



Strong written communication



Strong presentation skills



High level of attention to detail and accuracy



Understanding of Combinations Products Regulations and Design Controls







**PHYSICAL/MENTAL REQUIREMENTS**



The employee is regularly required to sit, talk or hear, stand and walk. Lifting boxes of 20 lbs. Specific vision abilities required by this job include ability to adjust focus. Must be able to travel 25% of the time. The noise level in the work environment is usually moderate.







Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.







Must possess a high level of manual dexterity







**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



Must have the ability to work effectively under and manage to strict production, time and performance deadlines.







Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.







**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.







This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. 1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees.







**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.







**Other Job Details:**







+ **Last Date to Apply for Job: 12/5/2017**







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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