Job Description: Scientist – Analytical Operations
Scientist – Analytical Operations (Fixed Term Contract 12 months)
Up to £60,000, plus bonus, and competitive package
Compass Life Sciences have exclusively partnered with a rapidly growing biotech focused on targeting rare genetic disorders using innovative gene therapies. The candidates will be working in a cutting-edge innovative biotech environment. The aim is to make a real difference to patients’ lives.
This is a maternity cover contract proposed for an initial 9-12 months, with a possibility of extension thereafter.
- Managing activities related to the development, validation and implementation of analytical methods for the testing, lot release and characterization of innovative gene-modified cell-based therapeutic products. More specifically, working with designated European Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs) this individual will manage activities to provide analytical support to facilitate the progression of product pipeline programs.
- Oversee the analytical functions associated with the development, GMP production and testing of products
- Execution, review and approval of release testing of raw materials, process intermediates, ancillary products, drug substances and drug products
- Manage activities at CMOs and CTOs for the development, qualification and implementation of analytical methods, including the design, review and approval of protocols, test records/forms, final reports and Standard Operating Procedures (SOPs)
- Oversee QC activities at CMOs and CTOs, including the review and approval of test records/forms, final reports, SOPs and Certificates of Analysis (CoAs)
- Oversee the execution of stability programs for raw materials, ancillary products, drug substances and drug products
- Drafting and review of SOPs, records/forms and protocols for in-house QC testing and overall analytical operations
- Support CMO production activities by coordinating testing activities with appropriate external and in-house departments
- Assist in the preparation of CMC regulatory submissions
- As a proven technical expert in the development, manufacture and delivery of cell-based therapy products with significant applied experience in the biotechnology industry, this candidate will possess:
- Significant experience in the biotechnology or pharma industry with a primary focus on the development, validation and application of analytical methods for product development, characterization and QC testing
- Experience of the characterization and QC release testing of viral vector-based and/or cell-based products
- Experience with the development, validation and application of analytical techniques in a QC environment, including FACS, High Content Analysis (HCA), ELISA, Capillary Electrophoresis, DNA sequencing, qPCR/PCR, cell culture and cell-based assays
- Experience of managing CMO / CTO/ CDMO relationships and projects
- Sound understanding and demonstrated application of statistical methods/tools
- In-depth knowledge of US and European Pharmacopeia methods and requirements
- In-depth knowledge of FDA, EMA, GMP, WHO and ICH regulatory requirements
- This position requires frequent on site presence at CMOs and contract vendors. Therefore, ability to travel is a pre-requisite
- A minimum BS in Biological Sciences, Bioengineering, Chemistry or an associated discipline
Our client is offering a generous package, competitive salary, and a genuine opportunity for someone to make a real difference. Contact Zoe Pindar-Ark at firstname.lastname@example.org
or 07779 24 27 98
Compass Associates Ltd is acting as a Recruitment Consultancy for this permanent vacancy; we offer £200 worth of John Lewis Vouchers for each successful recommendation.