Arcus Biosciences Careers

Director: Small-Molecule Drug Substance Development & Manufacturing

Arcus Biosciences (https://arcusbio.com/) is a clinical stage biotech company focused on immuno-oncology and inflammation with drug candidates in both monoclonal antibody and small molecule areas. Our Small Molecule Drug Substance Development and Manufacturing team is looking for an innovative, passionate, and collaborative project leader to contribute to our Small Molecule Pharmaceutical Development to support the advancement of Arcus drug development pipeline. ​

Responsibilities

• Project leadership roles on technical and operational aspects on one or more small molecule drug substance development and manufacturing projects within the CMC Team for both early and late phase development of Arcus’ experimental therapies
• Design, develop, and optimize synthetic processes suitable for drug substance manufacturing on production scale using resources within Arcus labs and scale up to kilogram scale if needed.
• Proactively manage CROs/CDMOs to manufacture regulatory starting materials and drug substances under cGMP as needed for clinical studies.  This will involve collaborative development and execution of robust, scalable manufacturing processes while meeting aggressive program timelines/budgets and long-term company goals.  
• For the late-stage project, lead the team in planning and executing registrational and PPQ campaigns in collaboration with Analytical, Quality, Regulatory groups to ensure all the goals are met for ultimate NDA and MAA filing and marketing approval. 
• Mentor and lead junior team members in technical skills development and foster a creative, collaborative team environment striving for the highest standard
• Author technical and regulatory documentation as required, including development plans, engineering protocols, risk assessments, technical reports, change controls, and IND/IMPD/NDA/MAA Quality sections
• Collaborate with Drug Product, Analytical Sciences, Toxicology, Discovery Chemistry, Quality areas to ensure effective collaborations across functional areas in support of company priorities

 Requirements

• PhD in organic chemistry with 10+ years’ experience in API process development in the biotech or pharma industry
• Demonstrated track record of innovation and problem solving in process chemistry
• Project leadership experiences from early-stage to late-stage drug substance process development, through registration batches and validation batches.  Experience in process characterization and validation campaigns is required. 
• Hands on working experience with all stages of drug development, as well as in-depth knowledge and understanding of cGMP requirements and CMC regulatory requirements for small molecule drug candidates  
• First-hand experience in writing/assisting with CMC documents for regulatory submissions and a good understanding of pharmaceutical development, quality, and regulatory issues.  Experience in document preparation for NDA/MAA filing is highly desirable.
• Demonstrated ability to effectively manage CROs and CDMOs to accomplish process development and drug substance manufacturing goals.  Ability to collaborate with teams across different cultures
• Demonstrated track record for developing and mentoring direct reports and other team members
• Excellent communication skills and the ability to work in a goal and team-oriented setting. 

• Ability to travel occasionally, as needed, to the sites of partner CDMOs

This role can be based at our Hayward, CA location. The anticipated salary range for fully qualified candidates applying for this position is $200,000 - $230,000 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 

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