Process Development Scientist: Remote Scale-Up & Transfer

Socket.dev; Cambridge (MA); On-site; USD 112,000 - 145,000; Full time

Benefits offered by this job

Stock

Retirement plan

Medical insurance

Life and disability insurance

Annual bonus eligibility

Sales incentive

Job summary

Socket.dev in Cambridge, MA is seeking a Process Development Scientist to support drug product commercialization and lifecycle management. You will design and execute characterization studies, evaluate manufacturing changes, and lead technology transfers within a cross-functional team.

You will author regulatory sections, apply statistics, and build data-driven process validation plans. A Master’s degree and 2+ years of experience are required; telecommuting may be available.

Qualifications

• Master’s degree in Chemical Engineering, Biochemical Engineering, Biochemistry or related field with 2+ years of relevant experience.
• Experience: statistical evaluation of data, assess correlations, evaluate process capability and run data simulations.
• Experience with process scale-up and technology transfer, including gap/root-cause/risk analyses.
• Design process validation and sampling plans; interpret results and write PQ reports.
• Develop statistical monitoring plans for process validation, triage excursions and remediation.
• Author/review regulatory documentation for filings and health authority inquiries; labs include aseptic handling and bench-scale fill-finish.

Responsibilities

• Provide input and support to commercialization and development of drug product processes.
• Design and execute characterization studies; evaluate product impact from manufacturing processes, scale, equipment, and raw materials changes.
• Prepare process transfer documents and contribute to regulatory submissions.
• Apply scientific and engineering principles to investigations and CAPA development.
• Support technology transfers and lifecycle management of commercial products.
• Collaborate with cross-functional teams (engineering, analytical, quality, regulatory, clinical, manufacturing).
• May telecommute.

Skills

Statistical analysis

Process development

Technology transfer

Design of experiments

Education

Master’s degree in Chemical/Biochemical Engineering or Biochemistry

Job description

Socket.dev in Cambridge, MA is seeking a Process Development Scientist to support drug product commercialization and lifecycle management. You will design and execute characterization studies, evaluate manufacturing changes, and lead technology transfers within a cross-functional team.

You will author regulatory sections, apply statistics, and build data-driven process validation plans. A Master’s degree and 2+ years of experience are required; telecommuting may be available.