Associate Director, Small Molecule Analytical Sciences

Description

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

Responsibilities

• Method development, impurity characterization, experimental design, and testing
• Authoring technical development reports and authoring/contributing to regulatory filings
• Management of CDMO/CRO activities (i.e., release, stability, method validation/transfer)
• Manage/Conduct in-house testing to support internal drug substance and drug product development
• 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 (including QA and Regulatory) 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 7 years of relevant industry work experience;
• or MS with 9 years of relevant industry work experience;
• or BS with 11 years of relevant industry work experience
• The ideal candidate will have direct experience in early to late phase small molecule drug substance and drug product development, with preference for expertise in supporting NDA filings and in drug product (tablet) analytical development
• Expertise in chromatography (primarily HPLC), mass spectrometry and dissolution method development
• 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
• Experience in design and execution of formal stability studies, development and validation of analytical methods, and managing these activities at CDMOs
• Understanding of applicable industry guidances and experience in executing phase-appropriate practices, particularly those relevant to late phase development
• Understanding of and experience in GMPs pertinent to analytical testing, including change controls, CAPAs, deviations, investigation reporting
• Competent communicator and technical writer with tangible prior experience authoring relevant sections of IND/IMPD filings
• Excellence in technical decision making and timeline awareness in relation to overall project goals
• 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 $195,000 - $215,000 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