Associate Director/Director, Process Chemistry

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
 
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 
 
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

What You'll Do

We are looking for an experienced Process Chemist Associate Director/Director to join our expanding CMC team. This position will work directly with our SVP of CMC and oversee CDMOs to manage drug substance development.  If you have a complete understanding of GMP requirements and experience working on various drug development phases, we would love to hear from you!

Responsibilities

• Oversee contract development and manufacturing organizations (CDMOs) to Process Chemistry activities for drug substance (DS) with a focus on late stage and validation

• Experience working across International and US based CDMO’s

• Regularly and clearly communicate Process Chemistry both verbally and in visual presentation form, efficiently and contextually

• Author and manage request for proposal documents to initiate work at CDMO’s

• Support and author DS content for CMC Regulatory for US and Rest of World with focus on late stage development and marketing applications

• Support Quality Assurance audits, on site at CDMO’s or remotely, as a technical subject matter expert, as needed

• Provide on-site technical support at CDMO’s on an as-needed basis to oversee various manufacturing/scale-up/validation activities. Provide technical expertise to troubleshoot manufacturing/packaging process issues

• Proactively interface effectively with other CMC team members (e.g., Analytical Chemistry, Formulation Development, Quality Assurance, Supply Chain, etc.)

Where You'll Work

This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.

Who You Are

• Degree (MS or Ph.D.) in synthetic chemistry

• 10+ years of pharmaceutical small molecule manufacturing/process chemistry experience

• Strong technical background in small molecule large-scale manufacturing, late-stage process development, and commercialization of APIs

• Familiarity with state-of-the-art technology development and implementation to improve manufacturing processes and analytical methodologies

• Fundamental understanding of GMPs, quality, and regulatory requirements

• Proven ability to manage CDMO’s to achieve goals on aggressive timelines

• Thorough understanding of broad CMC aspects concerning the development, manufacturing, and analysis of small molecule therapeutics

• Experience with reviewing master batch records, executed batch records, manufacturing deviations, and investigations

• Excellent working knowledge of process safety, QbD, PAT, and DOE

• Experienced in the use of systematic investigation techniques to identify causes of process deviations, e.g., root cause analysis

• Well-versed in the preparation of FMEAs

• Comfortable using statistical software and techniques to define experimental plans and interpret results (e.g., JUMP, StatEase).  Six Sigma certification is a plus

• Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a div