Principal Research Scientist - Analytical Development and Quality Control (Small Molecule and Biologics)

SRI International, an over 75-year strong pioneering research institute, has a rich history supporting government and industry. Our innovations have created new industries, billions of dollars in market value and lasting benefits to society. SRI is organized around broad disciplines and capabilities, with research and development divisions and labs to groups who excel at identifying new opportunities, developing products, and creating custom solutions. Our organization is driven by impact - delivering unique solutions for the world's important challenges and transforming ideas into reality for clients and partners.

SRI Biosciences has an immediate opening for a Senior Principal Scientist of Analytical Chemistry and Quality Control to be a part of the Pharmaceutical Sciences Department of the Biosciences Division. We are particularly interested in individuals with expertise in translational product development through IND and FDA.

The candidate will work in the Pharmaceutical Sciences Group located within the Biosciences Division at SRI. The Pharmaceutical Sciences group includes personnel working in the Pharmaceutical Formulation laboratories, Analytical Development and Quality Control laboratories, and the Pharmaceutical GMP manufacturing unit. This position is based on site at the Menlo Park campus. The Biosciences Division, of which Pharmaceutical Sciences is a part, has worked with our partners to advance more than 225 drugs to clinical trials, and 25 have reached the market. SRI has numerous partnership models, enabling flexibility in its research and development collaborations with industry and academic partners. Join our team and contribute towards the process of getting life-saving drugs to the market. We do not require overtime hours, and we do not work weekends.

This is an opportunity to join SRI International on exisiting contracts as well as expand out group into biologics moving forward. This role is based at our headquarters location in Menlo Park, CA.

The successful candidate will possess a detailed understanding of Analytical Method development and Quality Control in support of predominantly small molecule and a few large molecule manufacturing. The candidate must be highly motivated and demonstrate leadership quality. This role will have responsibility for oversight of the Analytical and QC Operations teams supporting R&D, GLP and GMP analytical testing, and lab operations.

The interview agenda will include an hour-long technical presentation by the prospective candidate.

Essential Duties and Job Functions:

Manages the Analytical Chemistry and Quality Control Operations function, ensuring processes provide high quality analytical support for drug substance and drug product production, including in process, microbiological, environmental monitoring, cleaning verification, purity, and potency testing. SRI has a fully compliant licensed GMP manufacturing facility. This position will be an integral part of the team that also includes a Quality Assurance group.
• Collaborates with preclinical development, formulation development and clinical manufacturing departments ensuring compliance of protocols, GLPs, GMPs, and safety regulations.
• Engages with prospective commercial clients in meetings, develops proposals and costing as required.
• Develops and validates analytical methods for both small and large molecules
• Leads structure elucidation studies using critical state of the art instruments.
• Demonstrated expertise on varied analytical methods, including, HPLC, LC-MS, NMR, capillary electrophoresis, Xray crystallography, particle testing, dissolution testing, thermal characterization etc.
• Provides guidance on QC requirements with stakeholders in project team meetings. Leads and represents QC requirements on multiple projects.
• Writes/develops proposals pertaining to analytical and quality control requirements for drug product development, in response to appropriate government solicitations
• Lead and direct efforts in support of laboratory investigations and critical improvements.
• Actively manages a group of Analytical and QC personnel and oversees their performance management, mentoring, and career development of direct reports.
• Works with Manufacturing, Regulatory & Quality Assurance to ensure that all procedures and applicable regulatory requirements are followed and properly documented.
• Must think critically and creatively and be able to work independently and have strong organizational and planning skills.
• Supports and/or coordinates internal and external regulatory audits as required.

• Doctorate with 5+ years of experience biotech/pharmaceutical professional experience in the analytical chemistry, biochemistry, pharmaceutics, or a related discipline from an accredited university. (At least 3 years experience post-PhD program)
• Excellent communication skills (both verbal and technical) and interpersonal skills are required.
• Demonstrated people management skills required
• In-depth knowledge of Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs)
• Demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders within biosciences group.
• In-depth knowledge of QC principles, concepts, industry practices, and standards
• Excellent writing skills and attention to details.

Additional, Preferred Experience and Skills:

• Knowledge and experience in commercial Quality Control in a regulated manufacturing environments is preferred

Demonstrated ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and clients.

The salary range is: $158,000 - $210,000/annually. Salary ranges will vary and are based on several factors, including geographic location, market competitiveness and equity amongst internal employees in similar roles. Positions may also qualify for SRI's Pay for Outstanding Performance program or the annual Performance Based Compensation program.

SRI also has a competitive benefits package, to view details please go to https://www.sri.com/resources/benefits/. SRI is an independent nonprofit research institute headquartered in Menlo Park, Calif., with a rich history of supporting government and industry. We create and deliver world-changing solutions for a safer, healthier, and more sustainable future. For more than 75 years, we have collaborated across technical and scientific disciplines to discover and develop groundbreaking products and technologies and bring innovations and ideas to the marketplace.