Director, Upstream MSAT & Process Development
Scorpion Therapeutics, Cambridge, MA, United States
Position Responsibilities:
Strategic & Functional Leadership:
Lead the CMC upstream MSAT and process development team for biologics (mAbs, fusion proteins, or similar).
Serve as the upstream processes thought leader for biologics manufacturing platforms, innovation, and process robustness.
Partner with stakeholders across R&D, Regulatory, Manufacturing, and Quality to ensure alignment from development to commercial readiness.
Technical Program Oversight:
Design and oversee upstream process development across all stages (early/IND-enabling through BLA/commercial lifecycle).
Guide scale-up, technology transfer, and validation activities across external manufacturing sites.
Enable robust process ownership and technical oversight for clinical and commercial manufacturing.
Author upstream technical reports to enable program stage progression and robust regulatory filing input.
External CDMO Management:
Manage relationships with CDMOs for upstream process development, ensuring scientific rigor, quality, and timelines.
Serve as the technical upstream lead for external development and manufacturing partnerships, including CDMO selection and oversight of SOWs, budgets, and technical deliverables.
Enable successful delivery of clinical and commercial product through deviation and batch record review, change control oversight, and person-in-plan support.
Organizational Development:
Build and lead a high-performing CMC upstream MSAT and process development team
Foster a culture of scientific excellence, cross-functional collaboration, and accountability.
Regulatory Support:
Author and/or review relevant CMC sections of regulatory submissions (IND, IMPD, BLA/MAA), including process descriptions, validation strategies, and control strategies.
Support regulatory agency interactions, inspections, and responses to information requests.
Candidate Requirements
Required:
Ph.D. or M.S. in Chemical Engineering, Biochemistry, or related field.
8+ years of relevant biopharmaceutical experience encompassing both MSAT and process development functions; at least 4 years in a leadership role(s).
Proven experience developing biologics processes from early-stage through commercial launch, including PPQ and lifecycle management.
Demonstrated expertise in drug substance process development of high-concentration biologics to mitigate drug product development challenges.
Strong background in tech transfer, scale-up, and working with external CDMOs.
Experience with process ownership and technical oversight for clinical and commercial manufacturing.
Experience supporting global regulatory submissions (e.g., FDA, EMA).
Preferred:
Experience in a lean, entrepreneurial biotech environment.
Familiarity with integrated CMC program leadership or technical operations governance frameworks.
Competencies:
Strategic and enterprise mindset
Deep technical expertise with strong decision-making capability
Effective communicator with cross-functional and external partners
Proactive, solution-oriented leadership style
High standards of scientific rigor and compliance
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Strategic & Functional Leadership:
Lead the CMC upstream MSAT and process development team for biologics (mAbs, fusion proteins, or similar).
Serve as the upstream processes thought leader for biologics manufacturing platforms, innovation, and process robustness.
Partner with stakeholders across R&D, Regulatory, Manufacturing, and Quality to ensure alignment from development to commercial readiness.
Technical Program Oversight:
Design and oversee upstream process development across all stages (early/IND-enabling through BLA/commercial lifecycle).
Guide scale-up, technology transfer, and validation activities across external manufacturing sites.
Enable robust process ownership and technical oversight for clinical and commercial manufacturing.
Author upstream technical reports to enable program stage progression and robust regulatory filing input.
External CDMO Management:
Manage relationships with CDMOs for upstream process development, ensuring scientific rigor, quality, and timelines.
Serve as the technical upstream lead for external development and manufacturing partnerships, including CDMO selection and oversight of SOWs, budgets, and technical deliverables.
Enable successful delivery of clinical and commercial product through deviation and batch record review, change control oversight, and person-in-plan support.
Organizational Development:
Build and lead a high-performing CMC upstream MSAT and process development team
Foster a culture of scientific excellence, cross-functional collaboration, and accountability.
Regulatory Support:
Author and/or review relevant CMC sections of regulatory submissions (IND, IMPD, BLA/MAA), including process descriptions, validation strategies, and control strategies.
Support regulatory agency interactions, inspections, and responses to information requests.
Candidate Requirements
Required:
Ph.D. or M.S. in Chemical Engineering, Biochemistry, or related field.
8+ years of relevant biopharmaceutical experience encompassing both MSAT and process development functions; at least 4 years in a leadership role(s).
Proven experience developing biologics processes from early-stage through commercial launch, including PPQ and lifecycle management.
Demonstrated expertise in drug substance process development of high-concentration biologics to mitigate drug product development challenges.
Strong background in tech transfer, scale-up, and working with external CDMOs.
Experience with process ownership and technical oversight for clinical and commercial manufacturing.
Experience supporting global regulatory submissions (e.g., FDA, EMA).
Preferred:
Experience in a lean, entrepreneurial biotech environment.
Familiarity with integrated CMC program leadership or technical operations governance frameworks.
Competencies:
Strategic and enterprise mindset
Deep technical expertise with strong decision-making capability
Effective communicator with cross-functional and external partners
Proactive, solution-oriented leadership style
High standards of scientific rigor and compliance
#J-18808-Ljbffr