1+ months

Technical Specialist, Clinical Manufacturing, 3rd Shift

Pfizer
Andover, MA 01810
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**Why Patients Need You**



Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

**What You Will Achieve**



The clinical manufacturing Technical Specialist, 3rd shift is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio. You will be part of a team responsible for the execution of production support activities (buffer and media prep and equipment prep), upstream mammalian and microbial processes, and downstream/purification processes. You will coordinate and may frequently lead production operations on the manufacturing floor during overnight activities. This role is a key communication and technical interface between the GMP manufacturing teams in the plant as well as partner organizations.



As part of the Technical Operations team, your prior work experience and ability to apply your breadth of knowledge will help you adapt the standard methods and procedures. You will help us identify required delivery and process improvements that drive increased efficiency, throughput and quality. You will arrive at decisions on which methods and procedures are the best fit for different work situations.



It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

**How You Will Achieve It**



+ Manage own time, professional development, and be accountable for own results. Work with a high degree of autonomy on 3rd shift.

+ Prioritize own workflow and assist in prioritizing the workflow of less-experienced colleagues.

+ Adhere to Good Manufacturing Practices and standard operating procedures, and material sampling instructions.

+ Execute buffer/media preparation, equipment preparation, and upstream and mammalian and microbial processes and purification processes in a {Current} Good Manufacturing Practices {part of GxP} environment.

+ Complete recurring assignments independently and select the most appropriate method or approach to do so within prescribed limits of authority.

+ Identify opportunities for continuous improvements and enable implementation, utilize continues improvement and root cause analysis tools.

+ Maintain cross-functional communication with tech transfer team, quality and engineering.

+ Perform troubleshooting of production support equipment and operations.

+ Understand scientific principles in order to problem solve and troubleshoot test results.

+ Report any deviation or observation that might lead to adverse impact to product quality.

+ Complete work instructions and maintains clean room environment to comply with regulatory requirements.



**Qualifications**

**Must-Have**



+ High School Diploma or GED.

+ 4+ years of experience.

+ Demonstrated experience in a biotechnology manufacturing or laboratory environment

+ Experience with Production Support/Central Services which supply manufacturing with critical solutions and equipment in a timely fashion.

+ Experience with either upstream or downstream processing in a drug substance manufacturing environment.

+ Experience in cGMP (Current Good Manufacturing Practices) compliance as related to manufacture of biologics.

+ Ability to think critically and demonstrate troubleshooting and problem-solving skills

+ Strong workload planning skills, organization, and attention to detail, and follow through. Excellent work ethic.

+ Ability to thrive in a team oriented and dynamic environment. Change agile.

+ Excellent written and verbal communication skills

+ Strong computer skills in Microsoft Office required e.g. MS Word, MS Excel



**Nice-to-Have**



+ Bachelor's Degree

+ Familiarity with OSHA standards and requirements



**PHYSICAL/MENTAL REQUIREMENTS**



Ability to effectively gown into and operate in a clean room environment for extended periods of time. Gowning may include coveralls, head cover, face mask, boot covers, and gloves.



Ability to lift up to 25+ pounds.



Ability to stand and walk for extended periods of time.



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



This is a 3rd shift/overnight position.



**Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.**



**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.



Manufacturing



\#LI-PFE
Posted: 2021-11-22 Expires: 2022-02-13
Sponsored by:
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Technical Specialist, Clinical Manufacturing, 3rd Shift

Pfizer
Andover, MA 01810

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