1+ months

Laboratory Manager

Pfizer
Columbia, MD 21044
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**ROLE SUMMARY**

This position is to manage the sites Biomedical Technology's mechanical research laboratory whose primary role is to evaluate combination drug delivery systems through the use of sound, safe and justifiable scientific methods. Develops evaluates and tests concepts, prototypes and ideas for new products and product improvements. The position will require that the staff utilize cGLP's in its daily activities such that samples are tracked, tested/evaluated and technical memos or reports are written and supplied to the site Technology and where applicable Product Development, Quality and Manufacturing groups. Responsible for adhering to design controls and documenting all product development work in a Design History File.



**ROLE RESPONSIBILITIES**



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

+ Ensure staffing levels are adequate to support test requirements

+ Ensure laboratory equipment is in compliance with Meridian requirements and maintained by the lab staff

+ Manage an appropriate documentation system to comply with Meridian standards and where appropriate 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, guidances and risk assessment files in the testing/evaluation of samples

+ Manage the laboratory and staff to meet all Meridian/site Safety standards - EHS

+ Manage the laboratory staff to evaluate Product development and where appropriate Complaint, Manufacturing and auto-injector defect samples. Ensure that the staff creates thorough and comprehensive evaluation reports with concise summaries explaining the lab's findings

+ Conduct testing where needed

+ Manage the staff to create technical reports

+ Review and approve laboratory memos and technical reports



**BASIC QUALIFICATIONS**



+ Bachelor's Degree in Biomedical Engineering or Mechanical Engineering preferred with 5 - 7 years experience in the Pharmaceutical Combination Products or Device industries.

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



**PREFERED QUALIFICATIONS**



+ Conceptual design skills and experience with a variety of manufacturing methods (e.g. injection molding, machining, etc.)

+ Experience in Human Factors and usability engineering

+ Strong skills in design software (preferably Solidworks) and other general computer software such as word processing, spreadsheets, presentations, etc.

+ Strong laboratory skills such as component inspection or failure analysis, mechanical testing, etc.

+ Strong mathematical, analytical, and reasoning skills

+ Strong problem solving skills

+ Strong creativity and innovation skills

+ Strong creativity astuteness

+ Strong research skills

+ Strong organizational skills

+ Strong in team work

+ Strong written and oral communication

+ Experience in complying with FDA Design Control Regulations for Combination Products per 21 CFR Part 4 and/or Medical Devices per 21 CFR 820.30 and EU Medical Device Directives

+ Ability to prioritize multiple responsibilities and to work on multiple projects simultaneously

+ Business acumen - demonstrates knowledge of market and competition

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

+ Laboratory management experience

+ Capable of working independently with minimal supervision

+ Strong presentation skills

+ High level of attention to detail and accuracy



The job is open only to Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents ("green card holders"), Refugees and Asylees.



Last Date to Apply for Job: March 31, 2020

Eligible for Relocation: Yes

Eligible Employee Referral Program: Yes



**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.



**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.



Quality Assurance and Control
Posted: 2020-01-27 Expires: 2020-04-05

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Laboratory Manager

Pfizer
Columbia, MD 21044

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