Clinical Manufacturing Associate

Clinical Manufacturing Associate

Summary:

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.

You will be part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substances supporting the Pfizer Biotherapeutics portfolio. Your initial focus will be as part of the manufacturing team focused on mammalian bio-processing. This includes and not limited to supporting the manufacturing operations team, reviewing Standard Operating Procedures, reviewing batch records, and standard work.

As part of technical operations, you will be a team member who is relied upon 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 make Pfizer ready to achieve new milestones and help patients across the globe.

Responsibilities:

• 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

Qualifications:

• High School Diploma or GED required, Bachelor's degree preferred
• A minimum of 0-3 years of relevant clinical manufacturing experience
• Demonstrated experience in a biotechnology manufacturing or laboratory environment
• Knowledge of cell cultures and/or downstream processing techniques preferred
• Mechanical aptitude and desire to execute hands-on manual labor preferred
• Operational knowledge of computerized systems
• Familiarity with Production Control Systems, Enterprise Resource Planning Systems and other business systems
• 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
• Must be able to climb flights of stairs, and remain standing for extended periods of time
• Must be able to lift up to 50 lbs
• Ability to thrive in dynamic team environment with diverse perspectives

Location/Schedule:

• This is a fully onsite role in Andover, MA
• Monday - Friday; 7:00 AM - 3:30 PM (weekend OT optional)

Please note contractors are engaged to provide services to Pfizer on a temporary basis in connection with a specific assignment. Contractors are hired and employed through Atrium, our third-party payrolling partner.

This job posting is for a temporary role as an employee of Atrium on assignment at Pfizer. The individual selected for this role will be offered the role as an employee of Atrium; compensation, medical benefits, fringe benefits, and other terms and conditions of employment shall be presented by Atrium upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued, and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements.