Technical Associate, Clinical Manufacturing in Andover, MA

Job Location: On premise

Work Scheule: Monday - Friday 7am - 3:30pm / Weekend OT optional

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 Clients 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 Client 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 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 Client 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.

Qualifications

Must-Have

• High School Diploma or GED
• 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 cell culture 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; nonroutine

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