Ligand Pharmaceuticals Senior Scientist, Analytical Sciences in San Diego, California
As a key member of the process development analytical team, the Sr. Scientist is responsible for executing analytical and biochemical characterization activities for biotherapeutic protein product development, including application of analytical technologies involving mass spectrometry, separations (HPLC), and structural protein 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 leadership 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.
Essentials for Working at Ligand* Ligand is a dynamic, fast-paced organization committed to creating shareholder value through developing and acquiring royalty revenue generating assets and coupling them to a lean corporate cost structure. To be successful at Ligand, employees must be innovative, efficient, versatile, self-starters who take great pride in their work and want to contribute to something significant.
Essential Role Responsibilities
Serve as Analytical Sciences subject matter expert in the development/ commercialization of recombinant proteins that requires knowledge and application of analytical technologies involving mass spectrometry, HPLC separations and other analytical protein structural characterization methods.
Expertise with HPLC and mass spectrometry of proteins and peptides (tandem mass spectrometry, ESI, MALDI, peptide mapping, HDX, structural analysis)
Provides expertise, guidance, and feedback on protein characterization and critical attributes so as to direct effective purification development and product/process control strategies
Responsible for method robustness and process knowledge prior to analytical method Tech Transfer to QC CMO for validation.
Method transfer owner/leadership between Pfenex & CMO and/or Pfenex partner.
Develops, implements, and manages state-of-the-art mass spectrometry methods for products, stability testing, product attribute identification and tracking, characterization of product degradation pathways, and comparability and biosimilarity assessments.
Partner with a diverse team of Process Development/ Characterization Scientists in USP, DSP and Analytical Sciences that support the advancement of a broad portfolio of products.
Keeps current in mass spectrometric method development field 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 Process Development/Characterization Studies and in technology transfer.
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
Track record of hiring top scientific talent.
Strong leadership & mentoring skills to lead a team of 2-3 scientists and/or associate scientists.
Strong publication record and scientific presentation skills, both written and verbal, to interact effectively with members of cross functional teams, as well as external partners and academic collaborators.
A minimum of a Bachelor’s degree in Analytical Chemistry/Biochemistry/Biochemical Engineering or related field with biosimilar and/or biologics experience required
BS in Biology/Analytical Chemistry/Biochemistry/Biochemical Engineering or related field
BS = 10 years of relevant industry experience
or PhD = 5 years 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
Knowledge of upstream and downstream process development for biotherapeutic protein production
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
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
Working knowledge of U.S. Government-funded programs is preferred
- The company offers competitive benefits including medical, dental, vision, Short/Long term disability and life insurance, as well as 401(k) match, Stock Options, Bonus, and paid time leave.
All new hires are required to go through a background and reference check
Affirmative Action Equal Opportunity Employer (EOE)
Must be legally authorized to work in the US without sponsorship
Ligand celebrates the diversity of life and welcomes all individuals to apply
No agencies or phone calls please
Keyword: Senior Scientist, Analytical Sciences
From: Ligand Pharmaceuticals