Technical Associate - Clinical Manufacturing - Pioneer Data Systems
Andover, MA 01810
About the Job
Position Details:
Our client, a world-leading Pharmaceutical Company in Andover, MA is currently looking for a Manufacturing Associate I to join their expanding team.
Job Title: Manufacturing Associate I / Pharma Industry
Duration: 12 months contract, extendable up to 36 months
Location: Andover, MA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Technical Associate - Clinical Manufacturing
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 Client'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 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 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 Pharmaceutical 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)
Ability to work nights and weekends as needed depending upon process needs; nonroutine
Our client, a world-leading Pharmaceutical Company in Andover, MA is currently looking for a Manufacturing Associate I to join their expanding team.
Job Title: Manufacturing Associate I / Pharma Industry
Duration: 12 months contract, extendable up to 36 months
Location: Andover, MA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Technical Associate - Clinical Manufacturing
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 Client'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 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 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 Pharmaceutical 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)
Ability to work nights and weekends as needed depending upon process needs; nonroutine
Source : Pioneer Data Systems