Cell Bank Testing Associate - 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 Research Associate to join their expanding team.
Job Title: Research Associate (Cell Banking, Cell Culture) / Pharma Industry
Duration: 18 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:
Cell Bank Testing Associate
Summary:
This role is part of Client's Bioprocess Research & Development Cell Banking team responsible for the manufacturing and testing of GMP cell banks used to produce clinical and commercial biopharmaceutical product.
This role will involve performing cell bank testing oversight activities, including identifying required tests, working with contract testing laboratories to manage testing submissions and providing technical review and interpretation of results.
This role is at the center of our operations and everything we do, every day, is in line with an unwavering commitment to quality.
A strong foundation in general scientific practice, its principles and concepts will help in meeting critical deadlines.
You will be relied on as a technical contributor to assess the assigned tasks and make decisions that involve direct application of your knowledge. It is your hard work and commitment that will make Client ready to achieve new milestones and help patients across the globe.
This is a non lab-based role supporting the scientific group
Responsibilities:
Coordinate cell bank/bulk harvest testing, including creation of specifications, submission of samples to testing laboratory and review and approval of results
Maintain all related data and records in compliance with cGMPs and quality procedures.
Collaborate with team members and partner functions (e.g. Quality Assurance) to ensure all cell bank testing-related quality and compliance requirements are met
Author technical documents and standard operating procedures (SOPs) Pay attention to detail, strictly adhere to standard operating procedures, and use knowledge to advance projects under rapidly shifting priorities and timelines
Support product investigations and new method evaluation(s) as needed.
Qualifications:
Associate's or Bachelor's degree in biology or a related scientific discipline with a minimum of 0-3+ years of relevant experience
Master's degree in Biology also accepted
Experience in a biologics manufacturing or laboratory environment
Good understanding of mammalian/microbial cell culture techniques
Good documentation skills with high attention to detail and strong organizational skills
Familiarity with cGMP requirements
Excellent oral and written communication skills
Experience with cell banking-related activities
Knowledge and practical application of microbiological/viral testing methods and molecular biology techniques
Experience with laboratory information management systems or documentation management systems
Technical writing experience for documents such as SOPs and technical documents
Ability to perform mathematical calculations and complex data analysis
Analytical testing experience is a plus
Location:
This is a fully onsite role in Andover, MA
Monday - Friday; first shift
Our client, a world-leading Pharmaceutical Company in Andover, MA is currently looking for a Research Associate to join their expanding team.
Job Title: Research Associate (Cell Banking, Cell Culture) / Pharma Industry
Duration: 18 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:
Cell Bank Testing Associate
Summary:
This role is part of Client's Bioprocess Research & Development Cell Banking team responsible for the manufacturing and testing of GMP cell banks used to produce clinical and commercial biopharmaceutical product.
This role will involve performing cell bank testing oversight activities, including identifying required tests, working with contract testing laboratories to manage testing submissions and providing technical review and interpretation of results.
This role is at the center of our operations and everything we do, every day, is in line with an unwavering commitment to quality.
A strong foundation in general scientific practice, its principles and concepts will help in meeting critical deadlines.
You will be relied on as a technical contributor to assess the assigned tasks and make decisions that involve direct application of your knowledge. It is your hard work and commitment that will make Client ready to achieve new milestones and help patients across the globe.
This is a non lab-based role supporting the scientific group
Responsibilities:
Coordinate cell bank/bulk harvest testing, including creation of specifications, submission of samples to testing laboratory and review and approval of results
Maintain all related data and records in compliance with cGMPs and quality procedures.
Collaborate with team members and partner functions (e.g. Quality Assurance) to ensure all cell bank testing-related quality and compliance requirements are met
Author technical documents and standard operating procedures (SOPs) Pay attention to detail, strictly adhere to standard operating procedures, and use knowledge to advance projects under rapidly shifting priorities and timelines
Support product investigations and new method evaluation(s) as needed.
Qualifications:
Associate's or Bachelor's degree in biology or a related scientific discipline with a minimum of 0-3+ years of relevant experience
Master's degree in Biology also accepted
Experience in a biologics manufacturing or laboratory environment
Good understanding of mammalian/microbial cell culture techniques
Good documentation skills with high attention to detail and strong organizational skills
Familiarity with cGMP requirements
Excellent oral and written communication skills
Experience with cell banking-related activities
Knowledge and practical application of microbiological/viral testing methods and molecular biology techniques
Experience with laboratory information management systems or documentation management systems
Technical writing experience for documents such as SOPs and technical documents
Ability to perform mathematical calculations and complex data analysis
Analytical testing experience is a plus
Location:
This is a fully onsite role in Andover, MA
Monday - Friday; first shift
Source : Pioneer Data Systems