Associate Director/Director, Drug Product Manufacturing
Scorpion Therapeutics, San Francisco, CA, United States
What You'll Do
You will be responsible for the oversight of drug product formulation and manufacturing process development and manufacturing at contract manufacturing organizations while facilitating clinical drug product disposition. You will also work with colleagues in CMC, Supply Chain Operations, Quality Assurance, and CMC-regulatory Affairs, while serving as an important point of technical contact between Calcilytix and contract research and manufacturing organizations.
Responsibilities
Formulation composition and manufacturing process development (experience with modified/extended release is a plus)
Person-in-plant oversight of the clinical and commercial drug product manufacturing process at CMOs (especially for small molecule solid oral dosage forms)
Perform activities related to batch review & release, deviations, change controls, investigations and other quality related work
Participate & provide input to root‑cause analysis and CAPA plans
Author/update regulatory filings
Where You'll Work This is a hybrid role and requires in‑office collaboration 2-3x per week in our San Francisco Office. Fully remote could be considered for the right candidate.
Who You Are
BS degree in Life Sciences, Engineering, or related field required, advanced degrees preferred
Minimum of twelve (12) years of relevant experience within the pharmaceutical industry required
Solid understanding of CMC manufacturing and analytical activities required in commercial drug product manufacturing, including knowledge of cGMP regulations.
Experience with cGMP quality oversight and on‑floor production support required
Understanding of Quality Management Systems required
Prior experience as a liaison with solid oral dosage form contract manufacturing organizations required
Experience with polymer characterization (rheology, DSC, TGA), dissolution, extrusion/spraying operations, and enteric coating preferred
Ability to periodically travel (up to 30% at times)
Salary $158,000—$215,000 USD
Benefits As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
Financial & Rewards
Market-leading compensation
401(k) with employer match
Employee Stock Purchase Program (ESPP)
Pre-tax commuter benefits (transit and parking)
Referral bonus for hired candidates
Subsidized lunch and parking on in-office days
Health & Well-Being
100% employer-paid medical, dental, and vision premiums for you and your dependents
Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
Fertility & family-forming benefits
Expanded mental health support (therapy and coaching resources)
Hybrid work model with flexibility
Flexible, “take-what-you-need” paid time off and company-paid holidays
Comprehensive paid medical and parental leave to care for yourself and your family
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, & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
#J-18808-Ljbffr
Responsibilities
Formulation composition and manufacturing process development (experience with modified/extended release is a plus)
Person-in-plant oversight of the clinical and commercial drug product manufacturing process at CMOs (especially for small molecule solid oral dosage forms)
Perform activities related to batch review & release, deviations, change controls, investigations and other quality related work
Participate & provide input to root‑cause analysis and CAPA plans
Author/update regulatory filings
Where You'll Work This is a hybrid role and requires in‑office collaboration 2-3x per week in our San Francisco Office. Fully remote could be considered for the right candidate.
Who You Are
BS degree in Life Sciences, Engineering, or related field required, advanced degrees preferred
Minimum of twelve (12) years of relevant experience within the pharmaceutical industry required
Solid understanding of CMC manufacturing and analytical activities required in commercial drug product manufacturing, including knowledge of cGMP regulations.
Experience with cGMP quality oversight and on‑floor production support required
Understanding of Quality Management Systems required
Prior experience as a liaison with solid oral dosage form contract manufacturing organizations required
Experience with polymer characterization (rheology, DSC, TGA), dissolution, extrusion/spraying operations, and enteric coating preferred
Ability to periodically travel (up to 30% at times)
Salary $158,000—$215,000 USD
Benefits As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
Financial & Rewards
Market-leading compensation
401(k) with employer match
Employee Stock Purchase Program (ESPP)
Pre-tax commuter benefits (transit and parking)
Referral bonus for hired candidates
Subsidized lunch and parking on in-office days
Health & Well-Being
100% employer-paid medical, dental, and vision premiums for you and your dependents
Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
Fertility & family-forming benefits
Expanded mental health support (therapy and coaching resources)
Hybrid work model with flexibility
Flexible, “take-what-you-need” paid time off and company-paid holidays
Comprehensive paid medical and parental leave to care for yourself and your family
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, & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
#J-18808-Ljbffr