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Technical Associate, Clinical Manufacturing, 3rd Shift

Location
Andover, Massachusetts
Job Type
Permanent
Posted
14 Jul 2022
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

You will be part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio. Your initial focus will be as part of the fermentation suite startup team to prepare the facility for operational readiness. This includes and not limited to supporting the manufacturing operations team, reviewing Standard Operating Procedures, reviewing batch records, and standard work. You will also support commissioning and qualification of process equipment. After the startup of the facility, you will transition to a team that will be responsible for the execution of microbial upstream and downstream processes.

As part of technical operations, you will be a team member who is relied to have a good understanding of procedures, techniques, tools, materials and equipment. Your decision making will help you prioritize workflows based on the available resources. You will follow standard procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing. You will contribute to the team s success by sharing of previously acquired knowledge.

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 and professional development, be accountable for own results and begin to prioritize own workflow.

  • Cross-functional communication with tech transfer team, quality and engineering as necessary.

  • Implement Current Good Manufacturing Practices part of GxP procedures and safe handling techniques for solid dosage processing within the continuous manufacture / PCMM work stream.

  • Ability to follow Standard Operating Procedures and work under minimal supervision.

  • Identify and support continuous improvement initiatives and root cause analysis tools.

  • Generate, assist and execute documentation associated with solid dosage manufacture, such as, working batch record documentation, in-process run sheets.

  • Complete activities identified as Operator care tasks associated with the maintenance and operation of complex pharmaceutical manufacturing equipment.

  • Actively participate in shift exchange activities and communication channels.

  • Complete training to take part in safety inspections within the facility.

  • Manage solution preparation and laboratory consumables.

  • Understand and comply with the policies, procedures and working practices of Environment, Health & Safety and where necessary contribute to the review and implementation of the practices in the plant.

  • Help to coordinate shipments of solutions and medias to other sites.

QualificationsMust-Have
  • High School Diploma or GED

  • 2+ years of experience combined in a biotechnology manufacturing or laboratory environment.

  • Operational knowledge of computerized systems

  • Familiarity with Production Control Systems, Enterprise Resource Planning Systems and other business systems

  • Maintains a safe work environment

  • Demonstrated capability to work as a team member in a matrix development team

  • Excellent oral and written communication skills

  • Strong computer skills in Microsoft Office required, especially MS Word, MS Excel

Nice-to-Have
  • Bachelor's Degree

  • Knowledge of fermentation and or downstream processing techniques

  • Mechanical aptitude and desire to execute hands on manual labor

  • 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

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Details

  • Job Reference: 658136516-2
  • Date Posted: 14 July 2022
  • Recruiter: pfizer
  • Location: Andover, Massachusetts
  • Salary: On Application
  • Sector: Healthcare & Medical
  • Job Type: Permanent