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Senior Scientist

The Senior Scientist will serve 60% of his or her time as Process Analytical Technology (PAT) lead. The remaining 40% of the time will be spent equally between developing robust chromatographic methods for protein-based therapeutics and serving as Analytical Team Lead (ATL). The method development role will involve developing methods for emerging on-line mode of real-time product quality monitoring of in-process samples as well as developing methods for current paradigm of off-line release testing. Scope of the method development includes evaluation, optimization and Design of Experiments (DOE) to establish robust techniques to support future commercial molecules. The PAT role will consist of developing, qualification and implementation on-line separation methods and sensor based technologies for real-time monitoring of product titer, product attributes, product impurities, bio-reactor nutrients/metabolites, etc. The successful candidate will work closely with Continuous bio-processing group, Process Development and Quality Testing groups within BMSnetwork and external contract laboratories. The role will have active interaction with Analytical Science and Technology (AS&T), Process Analytics and network method development teams. The successful candidate is expected to take active role in the planning and execution of basic analytical method development, method qualification, and method verification. The Senior Scientist will be responsible for generating high quality analytical data and authoring method development and qualificationreport as well as drafting and approving final method protocol. As an ATL, the Senior Scientist will assure the readiness of all analytical methods for the designated molecules. The ATL will be responsible for the timely release of clinical batches and out of spec investigation as well as establishing specifications and managing matrix organization. The successful candidate will have excellent communication skills, be a team player, and have experience in LC and CE base separation techniques as well as other analytical methodologies. Expertise in protein characterization using MS and Biophysical Characterization is highly desirable. The candidate will be involved in a continuous improvement of all analytical development activities. The candidate will help establish data trending and assay maintenance programs. Responsibilities: Develop and qualify analytical techniques for CHO derived monoclonal antibodies and fusion proteins as well as other CHO and E.coli derived recombinant proteins and peptibodied to support product release and stability studies Characterize impurity peaks using MS and Biophysical techniques Method transfer to GxP labs, CROs and CMOs Work in a Matrix environment by collaborating with Process Development, Process Analytical group as well as method development groups across multiple sites to develop harmonized methods Author and review technical documents and protocols; follows scientific methods and experimental protocols, documents results, author and review development and qualificationreports. Contribute analytical perspective to PD design of experiments and AS&T study protocols. Support testing site investigations as required. Trend system suitability data to track assay performance. Qualifications: The successful candidate will have A degree in Analytical Chemistry, Biochemistry, Chemical Engineering or related discipline. PhD with 4-6 years or MS with 10+ Years of relevant experience in Biopharmaceutical or Pharmaceutical industry.   A strong background in the areas of analytical chemistry/biochemistry or Chemical Engineering with strong emphasis on experience and in-depth working knowledge of Analytical techniques including HPLC, CE, Mass Spectrometry, etc. Experience with cGMP as applied to analytical methods is desirable Excellent communication and interpersonal skills Works independently and as part of a matrix organization Former experience in Process Analytical Technology (PAT) is preferred. The ideal candidate will execute assay development activities within Analytical development and testing network laboratories. The ideal candidate will develop on-line and off-line analytical methods for Novel Biologics candidates for LC and CE based analytical platforms as well as other emerging platforms. As an ATL, the candidate will fulfill the role of a CMC lead to manage a matrix team to ensure analytical timelines for release testing and stability programs are on track. The successful candidate will have excellent communication skills, a team player, and have in-depth and broad experience in Bioanalytical techniques as they apply to Biologics Product Quality and related process impurities. R1511622
Salary Range: NA
Minimum Qualification
11 - 15 years

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