Cell Bank Testing Associate
: Job Details :

Cell Bank Testing Associate

Contract; 18 Months

Location: Andover, MA

Pay Rate: $29.96/hr

Job Description

• This role is part of the 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 company ready to achieve new milestones and help patients across the globe.

Job 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.

ORGANIZATIONAL RELATIONSHIPS

• External CROs executing Cell Bank testing

• QA

• PharmSci Cell Bank team

Education & Qualifications

EDUCATION AND EXPERIENCE:

• Associate Degree or Bachelor's degree in biology or related scientific discipline with 0 - 3 years of relevant experience.

• Master's Degree in Biology.

TECHNICAL SKILLS REQUIREMENTS

Must Have

• 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

Nice-to-Have

• 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

PHYSICAL POSITION REQUIREMENTS

• Office Based

• Ability to perform mathematical calculations and complex data analysis