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 diverse team environment are essential 

• Strong initiative and desire to work in a fast-paced, team-oriented, dynamic environment

• Proficiency with Microsoft software (Word / Excel / PowerPoint)

• Position requires up to 20% travel

• Strong focus on quality and attention to detail

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 

• 401K with 100% employer match on first 3% & 50% on the next 2%

• Employee stock purchase program

• Pre-tax commuter benefits

• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents

• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)

• Hybrid work model - employees have the autonomy in where and how they do their work 

• Unlimited flexible paid time off - take the time that you need

• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents

• Flex spending accounts & company-provided group term life & disability 

• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility

• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching

• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities