Scientist, Small Molecule Drug Product Development & Manufacturing

Description

Summary

This role leads formulation and process development for drug candidates, including prototype design, tech transfer, and GMP manufacturing. It requires collaboration across teams, strong technical skills in oral formulations and analytics, and the ability to manage multiple projects efficiently.

Responsibilities

• Conduct pre-formulation and formulation development activities to support early development candidate selection, which include PK studies, non-GLP and GLP studies.
• Lead formulation development activities, including formulation prototype development, process development, in-vitro dissolution, and stability studies.
• Work with external manufacturing CMOs to enable tech transfer and implementation of drug product manufacturing process and GMP manufacturing.
• Under the guidance of the hiring manager in the drug product development group, help implement and maintain a state-of-the-art drug product development laboratory.
• Author and review technical protocols, development reports, GMP documentation such as manufacturing batch records.
• Responsible for technical leadership towards key formulation decision as part of the overall selection process for advancing molecule for development.
• Represent drug product group in core team meeting and develop strategy with other functions to prioritize and meet CMC deliverables.
• Interact effectively & build successful relationships with members of the drug product group, and with other Arcus stakeholders (Drug Substance, Quality, Analytical Development, Regulatory, Medicinal Chemistry, Clinical Operations & Discovery Biology).
• Consistently seek out, recognize and assess new technologies, and implement such for efficient, reliable & robust drug product development.

Qualications

• M.S or PhD. in Chemical Engineering or Pharmaceutical Sciences (or related discipline) with 1 - 2+ years of relevant industry experience.
• Experienced in oral formulation development, drug product process development, and technology transfer.
• Experience with analytical techniques for small molecules such as HPLC, DSC, TGA, XRPD, and other advanced formulation scientific equipment.
• The candidate should have a high degree of both flexibility and organizational skills as well as an eagerness and ability to learn in order to effectively navigate Arcus' multiple projects and timelines.
• Strong interpersonal skills: Ability to communicate effectively both verbally and in written formats are necessary to collaborate effectively with the rest of the Drug Product Development team and well as across other teams.
• Detail oriented, rigorous and excellent skills in record keeping/documentation.
• Experience in laboratory implementation & management is preferred.
• Proven ability to think creatively, and to obtain solutions to complex and diverse problems.

This role will be based at our Hayward, CA location. The anticipated salary range for fully qualified candidates applying for this position is $136,000 - $151,000 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.

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 their job.

EOE

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

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