Principal Scientist, Small Molecule Analytical Sciences

Description

Summary

This position will provide technical outputs and managerial oversight for the Small Molecule Analytical Sciences function within Arcus’ Pharmaceutical Development & Manufacturing organization. This onsite role will include laboratory and CDMO management responsibilities for assigned project(s) in support of drug substance and drug product development and manufacturing.

Responsibilities

• Method development, impurity characterization, experimental design, and testing
• Management of CDMO/CRO activities (i.e., release, stability, method validation/transfer)
• Manage and/or conduct in-house testing in support of internal drug substance and drug product development
• Authoring technical development reports and contributing to regulatory filings
• Review and approval of internal and CDMO analytical data and deliverables
• Infrastructure development, such as authoring SOPs/guidelines, and contributing to in-house laboratory functionality
• Collaborate with cross-functional CMC teams to achieve project goals
• Opportunities for analytical lead responsibility in CMC teams, personnel management, and/or ownership of infrastructure initiatives, as commensurate with experience and business needs
  
  

Qualifications

• Degree and experience:
• PhD with minimum of 5 years of relevant work experience;
• or MS with minimum of 7 years of relevant work experience;
• or BS with minimum of 9 years of relevant work experience
• The ideal candidate will have prior experience in both drug substance and drug product development, with preference for expertise in drug product (tablet) development) and in supporting NDA filings
• Expertise in chromatography (primarily HPLC) and dissolution method development; prior experience in mass spectrometry is also preferred
• Extensive practical experience in small molecule analytical testing techniques (e.g., HPLC, GC, MS, Karl Fischer, dissolution)
• Experience in setting specifications, product characterization and comparability studies
• Understanding of phase-appropriate practices, particularly those relevant to late phase development, and applicable industry guidances
• Understanding and experience in GMPs pertinent to analytical testing, including change controls, CAPAs, deviations, investigation reporting
• Competent communicator and technical writer with tangible prior experience
• Excellence in technical decision making and timeline awareness
• Hands-on, detail-oriented, committed to ownership and follow-through, and able to deliver in fast-paced projects
  

PHYSICAL REQUIREMENTS:

• Frequently stand, walk, twist, bend, stoop, squat, grasp lightly, use fine manipulation, grasp forcefully, perform desk-based computer tasks, use telephone, write by hand, lift, carry, push and pull objects weighing over 40 pounds.
• Occasionally sit, kneel, crawl, reach and work above shoulders, sort and file paperwork or parts.
• Rarely climb, scrub, sweep, mop, chop and mix or operate hand and foot controls.
• Must have correctible vision to perform duties of the job.
• Ability to bend, squat, kneel, stand, reach above shoulder level, and move on hard surfaces for up to eight hours.
• Ability to lift heavy objects, possibly weighing up to 50 pounds.
• Position may require repetitive motion. WORKING CONDITIONS:
• May require working near blood borne pathogens.
• May require work in an environment where animals are used for teaching and research.
• Position may at times require the employee to work with or be in areas where hazardous materials and/or infectious diseases are present.
• Employee must perform tasks that require the use of personal protective equipment, such as safety glasses and shoes, protective clothing and gloves, and possibly a respirator.
• May require extended or unusual work hours based on research requirements and business needs. *Consistent with its obligations under the law, the company will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
  
  

This role is based at our Hayward, CA location. The anticipated salary range for fully qualified candidates applying for this position is $165,000 - $190,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers .

Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets