Scientist, Small-Molecule Drug Substance Development and Manufacturing

Arcus Biosciences; Hayward (CA); On-site; USD 130,000 - 155,000; Full time

Job summary

An innovative biotech company is seeking a passionate Scientist to join their Small Molecule Drug Substance Development and Manufacturing team. This role involves developing and optimizing synthetic processes for small molecule drug candidates, ensuring high-quality production from preclinical stages to commercial launch. You will collaborate with various teams, conduct critical experiments, and contribute to regulatory filings. This is an exciting opportunity to be part of a dynamic environment where your expertise will directly impact the development of breakthrough therapies. If you are driven by scientific challenges and eager to make a difference, this position is for you.

Benefits

Stock Programs

Performance-Based Bonus

Comprehensive Benefits Package

Qualifications

• Ph.D. in Organic Chemistry or equivalent with relevant experience.
• Proven ability in synthetic organic chemistry and research.

Responsibilities

• Develop efficient synthetic processes for APIs from lab scale to commercial production.
• Collaborate with teams for process transfer and GMP manufacturing.

Skills

Synthetic Organic Chemistry

Analytical Methods (NMR, MS, HPLC)

Research Skills

Interpersonal Skills

Organizational Skills

Problem Solving

Education

Ph.D. in Organic Chemistry

MS with 3+ years related experience

BS with 5+ years related experience

Job 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 Scientist position to support our small molecule drug development pipeline.

Responsibilities

• Be a passionate, creative, and collaborative member of the Small Molecule Drug 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 troubleshoot 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.
• Provide technical review of master batch records.
• 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 Drug 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 MS with 3+ years related experience or BS with 5+ years related experiences.
• Well trained in modern synthetic organic chemistry, including synthetic methodology, reaction mechanism, and modern analytical methods (NMR, MS and HPLC). Maintain broad up-to-date knowledge of current synthetic organic chemistry field as well as industrial trends through scientific literature and participation in conferences.
• Proven ability to carry out independent in-depth research in the areas of design and implementation of efficient synthetic routes for complex target organic compounds and/or development of new synthetic methodologies. Established track record for strategic thinking and creative problem solving. A good publication record is desirable.
• Excellent interpersonal skills, including clear, succinct, and timely oral and written communications.
• Proven ability to foster collaborative relationships with key stakeholders.
• Excellent organizational skills, with ability to successfully manage multiple priorities.
• Late-stage process characterization and NDA filing work experiences such as process range finding, impurity fate and purges, technical report writing to support NDA filing are highly preferred.

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.

This role is based at our Hayward, CA location. The anticipated salary range for fully qualified candidates applying for this position is $130,000 - $155,000 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 identity, 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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