Associate Scientist, Biosafety and Bioassay Development

Job Detail

Main Duties & Responsibilities:

The major responsibilities are:

Develop, optimize and perform routine species specific virus detection assays to detect adventitious viruses in raw materials, in-process samples and other biological samples during various stages of manufacturing.
Perform test methods for the detection adventitious agents (Bacteria, Fungai and viruses) and report following the sample management process. If required generate risk-based testing approach for cell and gene therapy programs

Develop and optimize species specific virus detection assays to detect adventitious viruses in raw materials, Active Pharmaceutical Ingredient (API) and other biological samples during various stages of manufacturing.
Develop test methods for the detection adventitious agents and to generate risk-based testing approach for cell and gene therapy programs.
Develop test method for karyotyping to examine chromosomes in the cells
Collaborate with cross-functional teams (upstream, downstream, and formulation) in a multidisciplinary environment and be responsible for multiple projects.
Generate and manage required microbial and viral biosafety testing related documents example; Standard Operating Procedures (SOP’s), White Papers and Risk Assessments within the BioPharmaceutical Development (BPD) group.
Independently develop and manage strategy for validation and product specific qualification (PSQ) for both microbial and viral biosafety testing.
Responsible for developing, reviewing study plans, reports and coordinating studies at outside testing laboratories for all biosafety testing.

Education & Experience Requirements:

BS/MS in Molecular Biology, Cell Biology, Virology, Immunology or Biological Sciences.
Bachelor’s degree with 0+ years or Master’s degree with 0+ years of relevant industry experience.
Relevant industry experience is essential for this role.

Required Skills:

Hands-on experience with molecular techniques: DNA & RNA extraction, primer designing, PCR, qPCR, digital PCR and Gene arrays.
Expertise in library construction, sequencing (Next Generation, High Throughput Sequencing technologies) and bioinformatics analysis for product identification and detection.
Hands-on experience in cytogenetics, gene expression studies for cell and gene therapy products, RNA, DNA and viral vaccines.
Work experience with viral vector for titer determination by infectivity assays (focus forming unit assay, TCID50, plaque assay) and gene copy number (GCN) determination by qPCR or digital PCR assays.
Experience in functional characterization and potency assays development for monoclonal antibodies, oncolytic viruses and viral vectors.
In depth knowledge and experience with bioassay development, optimization, technology transfer, assay qualification and validation following ICH guidelines.
Knowledge on biosafety testing such as; sterility, bioburden, mycoplasma and adventitious agents detection testing for microbial contamination and identification.
Demonstrated ability to work effectively and collaboratively with other scientists on cross-functional projects teams.
Excellent oral presentation and communication skills, both written and verbal.

Desired Skills:

Strong ability to work both independently and in a team environment
Strong ability to multi-task and prioritize workload
Strong scientific skills including sound experimental design (DOEs), data processing, interpretation and presentation
Proficient in MS Word, Excel, Power Point and other applications
Knowledge of cGMP, FDA and ICH guidelines for biologics manufacturing
Experience managing tech transfers to Contract Research Organization (CROs)/ Outside Testing Labs (OTLs)
Experience working on Early, Mid to Late stage Cell & Gene Therapy. Viral, mAbs products is a plus
Familiarity with regulatory guidance and submissions for vaccines and cell and gene therapies

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