Director, Manufacturing Science and Technology
Description:
We are seeking a dynamic and experienced MSAT Director to support late-stage development through launch/commercialization activities.
Central to success will be engaging with CDMO(s) to deliver processes that enable robust production of Drug Substance (DS) for monoclonal antibodies.
This interdisciplinary position will provide expertise across cell line, cell culture, purification, and formulations, including scale-up from lab to manufacturing scale.
Requirements:
BS, MS, PhD in relevant discipline (e.g., biology, biochemistry, biochemical engineering, or relevant field) or commensurate years of education and experience
10+ years biologics development and manufacturing experience
Experience with late phase development and commercialization of biologics within relevant process areas (upstream cell culture, downstream processing, solution prep, cleaning, automation, data systems, etc.)
Experience with tech transfer to CDMOs and supporting DS campaigns through... scale up and validation
Experience with process and economic modeling of DS manufacturing processes
Demonstrated aptitude in collaborating with cross-functional partners, including clinical development/operations, analytical development, QA, RA, and supply chain.
Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
Demonstrated growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment
Ability and willingness to travel up to 25% including to CDMOs
Ability to multi-task and keep pace with a fast-moving organization
Availability to participate in calls across multiple international time zones
Benefits:
A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Flexible PTO
Two, one-week company-wide shutdowns each year
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve
Apply Now
We are seeking a dynamic and experienced MSAT Director to support late-stage development through launch/commercialization activities.
Central to success will be engaging with CDMO(s) to deliver processes that enable robust production of Drug Substance (DS) for monoclonal antibodies.
This interdisciplinary position will provide expertise across cell line, cell culture, purification, and formulations, including scale-up from lab to manufacturing scale.
Requirements:
BS, MS, PhD in relevant discipline (e.g., biology, biochemistry, biochemical engineering, or relevant field) or commensurate years of education and experience
10+ years biologics development and manufacturing experience
Experience with late phase development and commercialization of biologics within relevant process areas (upstream cell culture, downstream processing, solution prep, cleaning, automation, data systems, etc.)
Experience with tech transfer to CDMOs and supporting DS campaigns through... scale up and validation
Experience with process and economic modeling of DS manufacturing processes
Demonstrated aptitude in collaborating with cross-functional partners, including clinical development/operations, analytical development, QA, RA, and supply chain.
Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
Demonstrated growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment
Ability and willingness to travel up to 25% including to CDMOs
Ability to multi-task and keep pace with a fast-moving organization
Availability to participate in calls across multiple international time zones
Benefits:
A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Flexible PTO
Two, one-week company-wide shutdowns each year
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve
Apply Now