Sr. Scientist - Protein Separation/Characterization

As a key member of the Analytical Science team, the Sr.  Scientist is responsible for executing analytical and biochemical characterization activities for biotherapeutic protein product development, including assay development, assay qualification, and product characterization. This position must effectively communicate timelines and issues to ensure successful manufacturing, product testing/release and data package for regulatory filings. Individual technical issue management and cross functional communication are key position attributes. The candidate will work in a team environment, collaborating with various departments to ensure that manufacturing processes are properly characterized to support process transfer, achieve project goals, and timelines. The ideal candidate will have expertise with HPLC and various analytical separation techniques.

ESSENTIAL DUTIES AND PRIMARY RESPONSIBILITIES

• Serve as Analytical Biochemistry (AB) subject matter expert in the development/ commercialization of recombinant proteins that requires knowledge and application of analytical technologies involving primarily HPLC separations, icIEF, CE-SDS,  SDS-PAGE, Western blots, UV-Vis spectrophotometry, and other analytical protein characterization methods.

• Responsible for developing method robustness and other analytical parameters prior to analytical method Tech Transfer to QC CMO for validation.

• Facilitate and lead method transfers between CMO and/or partner.

• Partner with a diverse team of Process Development/ Characterization Scientists in USP, DSP and Analytical Biochemistry that support the advancement of a broad portfolio of products.

• Provides expertise, guidance, and feedback on protein analytical results so as to direct effective purification development and product/process control strategies

• Keeps current in analytical method development including literature and technology development and regulatory driven activities

• Author/Review detailed analytical reports and provides direct input/data/statistical analysis to support data package for regulatory submission(s).

• Interface with contract manufacturing or research organizations (CMOs/CROs) in the execution of analytical method transfer, testing, and release and stability studies.

• Assembles and delivers CMC supporting regulatory documentation required to rationalize process analytical, characterization, and release specifications

• With minimal supervision, generates and delivers concise/clear technical presentations to senior management

• Other duties as assigned or required

QUALIFICATIONS

 A minimum of a Bachelor's degree in Analytical Chemistry/Biochemistry/Biochemical Engineering with biosimilar and/or biologics experience required

• BS in Biology/Analytical Chemistry/Biochemistry/Biochemical Engineering or related field

• BS 5 years of relevant experience w/a minimum of 7 years of industry experience

• or MS 3 years of relevant experience w/a minimum of 3 years of industry experience

• or PhD 6 to 12 months of relevant industry experience

• Ability to travel up to 10% (US and Internationally)

• Fluent in practical application of PC's, Microsoft project, Word, Excel, Power point and experience to include data analyses, statistical analysis (JMP), method transfers and comparability studies

• Experience in developing and qualifying analytical methods, primarily HPLC separations

• Scientific understanding of current analytical technologies, as well as the ability to explore and develop novel approaches to further advance innovative analytical methodologies

• Proven working knowledge and understanding of GxP (GLP, cGMP, GCP and ISO9000) environments and regulations required

• Ability to work flexible work schedules

• Analyzes reports, metrics and results as required; provides SME and strategic guidance based on findings

• Excellent verbal and written communication skills, an innovative approach to problem-solving, an integrated view of business/scientific issues, and a strong work ethic

• Possesses and demonstrates exceptional research and resource utilization skills as well as practical problem solving capabilities

• Proven ability to work in a lean organization and creatively tackle problems using colleague networks and publicly available solutions; work independently and successfully in a matrix environment; and prioritize and manage multiple tasks simultaneously

• Other duties as assigned or required

Supplemental Experience (Strong Plus)

• Experience working in a biosimilars drug-development organization highly preferred

• Experience with the full product lifecycle of a biopharmaceutical product (i.e. Phases 1 4) highly preferred