Director, Large Scale Process Development

Scorpion Therapeutics; New Jersey; On-site; USD 195,000 - 218,000; Full time

Benefits offered by this job

Annual bonus

Medical insurance

Dental insurance

Vision insurance

401(k) match

PTO 20 days

Job summary

Scorpion Therapeutics is seeking a Director of Large Scale Process Development in Branchburg, NJ, on-site five days a week. You will lead scale-up for cell processes for clinical and commercial manufacturing, providing strategic and technical leadership to a PD/engineering team.

The role requires 10+ years in biopharmaceutical process development, scale-up, tech transfer, and GMP manufacturing, with BS/MS/PhD in a related field.

Qualifications

• Experience in process scale-up (cell therapy) and GMP manufacturing.
• Ability to lead scientific teams and mentor researchers.
• Strong reading/writing of GMP documents (batch records, SOPs, CAPAs).

Responsibilities

• Lead all scale-up efforts for cell processes for clinical and commercial manufacturing.
• Provide strategic and technical leadership to a PD/engineering team.
• Oversee scale-up/scale-down experiments for cell expansion, differentiation, and filling.
• Serve as PD lead in mid-to-late stage programs.
• Build scale-up capabilities with state-of-the-art tech and engineering principles.
• Collaborate with process development, MSAT and Manufacturing for tech transfer.
• Act as SME during GMP manufacturing and side-by-side activities.
• Lead authoring of regulatory submissions and engage with authorities for IND/CTA/IMPD/CTN.
• Communicate findings via presentations, protocols, and reports.
• Manage resources, scheduling, budgeting; mentor team.

Skills

Scale-up experience

Process development

Tech transfer

GMP manufacturing

Leadership

Mentoring

Scientific reasoning

Education

BS/MS/PhD in related field

Job description

Role: Director, Large Scale Process Development (Branchburg, NJ; 5 days/week on-site)

Responsibilities:

• Lead all scale-up efforts for cell processes for implementation in clinical and commercial manufacturing.
• Provide strategic, technical, and scientific leadership to a team of process development scientists and engineers.
• Oversee scale-up/scale-down experiments for cell expansion and differentiation, cell harvesting, and intermediate/final drug product container filling.
• Serve as process development lead in mid to late-stage development programs.
• Build scale-up capabilities by implementing state-of-the-art technologies, computational tools, and engineering principles for scale-up, development, characterization, validation, tech transfer, and GMP implementation.
• Collaborate with process development groups, MSAT, and Manufacturing to tech transfer processes.
• Act as subject matter expert during GMP manufacturing (including side-by-side GMP activities as needed).
• Lead authoring and internal review of regulatory submissions and engage with health authorities for IND/CTA/IMPD/CTN for first-in-human studies.
• Communicate via presentations, protocols, and reports; support external presentations/publication as appropriate.
• Manage resourcing, scheduling, and lab activity coordination; estimate, report, and manage departmental budget.
• Mentor team members and contribute to a strong technical culture.

Qualifications:

• BS/MS/PhD in Biomedical Engineering, Chemical Engineering, Biotechnology, Biological Sciences, or related field.
• PhD with 10+ years or BS/MS with 15+ years in biopharmaceutical/cell therapy process development, scale-up, tech transfer, and GMP manufacturing.

Required/Preferred Skills:

• Demonstrated experience in process scale-up (cell therapy), process development/optimization, tech transfer, and GMP manufacturing.
• Technical excellence in scale-up engineering principles.
• Ability to interpret GMPs for clinical product manufacturing.
• Ability to read/write technical and quality documents (batch records, SOPs, change requisitions, non-conformances, CAPAs).
• Leadership skills for scientific teams and matrix environments; ability to coach/mentor.
• Strong scientific reasoning and skills in process development, scale-up, cell culture, cell isolation, filling, and GMP manufacturing.

Benefits:

• Annual performance-based bonus; medical/dental/vision insurance; 401(k) match; 20+ days PTO.

Compensation:

• Expected annual salary range: $195,000-218,000.