Senior Manager, MSAT Drug Substance

Keros Therapeutics•Lexington, MA

2d•$105,000 - $126,000

About The Position

At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-β signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-β superfamily and provide disease-modifying benefit to patients. Job Summary: The ideal candidate will have a deep understanding of biologics drug substance production (upstream and downstream), tech transfer, and regulatory submission support. The candidate will engage and work with external partners (CDMOs) to ensure successful cGMP manufacturing campaigns and provide technical leadership of deviations, investigations, and change controls. The individual will also serve as a key process owner by evaluating process performance in order to drive continuous improvements. The individual should also be flexible to provide support for Keros internal Process Development operations as needed. The individual will work closely with regulatory in preparation of regulatory filings and RTQs.

Requirements

BS with 10+ years or MS with 8+ years or PhD with 5+ years of experience in biologics process development (upstream and/or downstream); process scale-up; technology transfer; cGMP manufacturing support; and regulatory submissions for protein therapeutics
Understanding of regulatory requirements and experience with authoring and reviewing CMC documents for multiple regulatory submissions
Excellent collaboration skills and ability to work cross functionally to achieve objectives
Strong work ethic, motivation, and scientific curiosity

Nice To Haves

Experience working in process development labs preferred but not required
Experience working with CDMOs for facility fit and tech transfer
Experience with cell culture and/or purification and scale-up
Experience with process data analysis and trending and statistical analysis preferred
Experience with technical support of commercial products in external cGMP manufacturing including investigations and change management

Responsibilities

Collaborate cross-functionally with process development to deliver manufacturing processes that meet the speed, yield, and product quality requirements of the development programs
Provide key technical upstream and downstream leadership for development programs including technology transfer, process design, manufacturing support, and person-in-plant
Lead technology transfer activities, including process fit and facility design at external CDMO, ensuring gap analyses and risks assessments are performed technical mitigations are in place for early stage MFG (Phase 1 and Phase 2)
Review and approve technical documentation including protocols, master batch records, and reports related to engineering and GMP runs
Support continuous process improvement and scale up activities using data analysis to increase yield while maintaining quality attributes for manufacturing process lifecycle management
Collaborate cross-functionally to support clinical drug substance manufacturing processes, tech transfer, supply chain, quality compliance, change management and product life cycle management
Provide guidance and author content for CMC regulatory submissions and ensure technical compliance with regional regulatory requirements
Partner with product development, manufacturing, quality and regulatory, lead quality investigations and data analysis as SME to address OOS, OOT, complex deviations/non-conformances and implement change controls to ensure timely/prompt release of batches to meet regional demand forecast and ensure CAPAs are in place
Support Process Development team by performing USP or DSP experiments as necessary
Cultivate excellent working relationship with CMC stakeholders to deliver successful manufacturing campaigns