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Technical Specialist, Clinical Manufacturing, 3rd Shift

Employer
Pfizer
Location
Andover, Massachusetts
Start date
Sep 11, 2022

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Job Details

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 is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio. The initial focus of your role will be on the start-up of a new facility in support of facility/equipment commissioning and qualification, creation of necessary cGMP documentation, and training within the production support area. You will be part of a team responsible for the execution of upstream mammalian and microbial processes. You will coordinate and lead production operations on the manufacturing floor, including taking a lead role in the qualification of process equipment, supporting development, clinical, and launch activities. This role is a key communication and technical interface between the GMP manufacturing teams in the plant and our 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.

  • 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 downstream mammalian and microbial purification processes in a {Current} Good Manufacturing Practices {part of GxP} environment.

  • Responsible for the equipment preparation, formulation and filling of biologic drug products.

  • 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.

QualificationsMust-Have
  • High School Diploma or GED with 4+ years of experience in a combination of Demonstrated experience in a biotechnology manufacturing or laboratory 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 written and verbal communication skills

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

Nice-to-Have
  • Bachelor's Degree

  • Certification in assigned area, if applicable

  • Drug product filling/ Final fill experience

  • Clean room experience


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 25+ lbs.

  • Ability to stand and walk for extended periods of time.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Be able to work during non standard hours and weekends.

  • This is a third shift position working overnights

Other Job Details:

  • Eligible for Sign on Bonus

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

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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