Senior Scientist / Associate Director, Drug Product Manufacturing

Company Overview

Calcilytix

What You'll Do

You will be responsible for the oversight of commercial drug product manufacturing at contract manufacturing organizations while facilitating global commercial 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 manufacturing organizations.

Responsibilities

• 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

• Participate & provide input to root-cause analysis and CAPA plans

• Participate in process confirmations, change controls, & quality oversight

• Coordinate investigations at external sites related to OOS/OOT, deviations, and unexpected analytical results

• Perform trend analysis of testing and process data for commercial drug products and participate in continuous improvement projects

• Generate batch genealogy for commercial materials

Where You'll Work

This is a hybrid role and requires in-office collaboration 2-3x per week in our San Francisco Office.

Who You Are

• BA/BS degree in Life Sciences, Engineering, or related field required

• Minimum of eight (8) years of 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

• Ability to periodically travel (up to 30%)

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