Principal Scientist, Small-Molecule Drug Substance Development and Manufacturing

Description

Arcus Biosciences (https://arcusbio.com/) is a biotech company focused on immuno-oncology with clinical stage drug candidates in both monoclonal antibody and small molecule areas. Our Small Molecule Drug Substance Development and Manufacturing team has an opportunity for a Principal Scientist position to support our small molecule drug development pipeline.

Responsibilities

• Be a passionate, creative, and collaborative member of the Small Molecule Dug Substance Development and Manufacturing team that strives to create the best manufacturing process to support Arcus small molecule pipeline from preclinical development to commercial launch.
• Develop efficient, phase appropriate synthetic processes for APIs through effective lab scale R&D, which will include but not limited to route design, route scouting and process optimization toward suitable API synthesis for development and commercial production. Design and execute critical experiments to trouble shoot process issues encountered in large scale productions. Conduct lab experiments such as the establishment of process ranges, impurity fate and purges to support process characterization and process validation for late-stage projects.
• Work in a team of Arcus scientists and partner contract development and manufacturing organization teams to develop efficient manufacturing processes for small molecule drug substance preparation under GMP. The projects may encompass clinical stage candidates through commercial launch. Responsibilities will range from initiating process transfer, through scale up, GMP manufacturing and process validation activities.
• Help manage process chemistry and GMP manufacturing efforts at CROs/CMOs and the sourcing of related raw materials and intermediates. Provide technical review of master batch records. Manage part of a project such as an individual GMP step or GMP starting material manufacturing with minimal management supervision.
• Provide person-in-plant support for manufacturing at CMO sites as needed by traveling either domestically or overseas.
• Provide concise technical updates to the Small Molecule Dug Substance Development and Manufacturing organization and key stakeholders in partner functions.
• Partner with Drug Product, Analytical Sciences, Quality Control and Quality Assurance to help ensure Arcus' manufactured GMP drug substances are delivered on time with appropriate quality.
• Contribute to writing / reviewing CMC sections of regulatory filings as needed.

Qualifications

• Ph.D. in Organic Chemistry or related field.
• 6+ years (M.S. with 9+ years or B.S. with 12+ years) of relevant experience in the biotech/pharmaceutical industry.
• Expert knowledge of process chemistry, synthetic organic chemistry, analytical methods (NMR, MS and HPLC) and physical-chemical characterization of compounds.
• Proven ability to develop, optimize and scale up drug substance manufacturing processes. Established track record for strategic thinking, creative problem solving
• Demonstrated technical, organizational and communication skills needed to manage GMP and RSM contract manufacturing organizations, such as attention to details, prioritizing different tasks and work under timeline and budget constraints.
• Experiences with work related to late-stage drug substance process development toward NDA, such as process characterization studies to establish process ranges, determine critical process parameters (CPPs), impurity fate and purge studies, multiple process factor studies via DOE are preferred.
• Excellent interpersonal skills, including clear, succinct, and timely communication and proven ability to foster important relationships with customers and key stakeholders. Excellent oral and written communications skills.
• Experience in CMC regulatory documents preparations, especially NDA related documents, is required.

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