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Manufacturing Specialist

3 months ago

Andover, United States Rangam Full time

Rangam SourceAbled is seeking candidates for a full-time direct hire role as a Clinical Manufacturing Technical Associate in Andover, MA with our client Pfizer, one of the world’s largest pharmaceutical companies.


Seeking candidates in or near Andover, MA.


*This position is being offered as part of a disability/neurodiversity hiring program which is designed to provide a more inclusive and supportive hiring process and work environment for job seekers with physical and cognitive disabilities, which includes, but is not limited to autism, ADD/ADHD, PTSD, OCD, Anxiety Disorder, Dyslexia, Bipolar, and Tourette's Syndrome*


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.


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.


Qualifications

Must-Have

  • High School Diploma or GED
  • 2+ years of experience
  • Demonstrated experience 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

PHYSICAL/MENTAL REQUIREMENTS

  • 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


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS


  • Ability to work nights and weekends as needed depending upon process needs, non-routine



The salary for this position ranges from $23.28 to $38.80 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided applies only to the United States - Massachusetts - Andover location.