Process Development Associate Scientist

Client is seeking a Process Development Associate Scientist for an onsite position in Cambridge, MA. This role supports the development of innovative biologic therapies in late-stage development through analytical method development, protein characterization, process development activities, and laboratory-based scientific research.

Responsibilities

• Work in a cross-functional team environment to support and advance therapies in late-stage development.
• Perform analytical characterization of protein-based biologic therapies using advanced analytical techniques, including capillary electrophoresis and liquid chromatography.
• Conduct compendial testing, including pH, visual appearance, turbidity, and other applicable analytical assessments.
• Support the development, optimization, qualification, and troubleshooting of analytical methods.
• Analyze experimental data and document results accurately in electronic laboratory notebook systems.
• Prepare technical protocols, laboratory records, reports, and other scientific documentation.
• Present experimental findings and project updates during team meetings.
• Assist with activities related to regulatory filings and submissions as needed.
• Troubleshoot, maintain, and support HPLC/UPLC instrumentation to ensure reliable analytical performance.
• Utilize Empower software for activities such as custom field creation, instrument method development, and data management.
• Maintain laboratory practices and documentation in accordance with applicable quality and compliance standards.

Requirements

• Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline with a minimum of 2 years of scientific or pharmaceutical industry experience.
• OR Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline with a minimum of 4 years of scientific or pharmaceutical industry experience.
• Minimum of 2 years of laboratory experience in an industry setting.
• Experience supporting analytical chemistry and/or biochemistry activities.
• Experience working within the biopharmaceutical industry.
• Experience generating technical documentation and maintaining accurate scientific records.
• Experience collaborating within cross-functional scientific teams.

Skills

• Strong laboratory skills and hands-on analytical testing experience.
• Analytical chemistry and/or biochemistry expertise.
• Experience with protein characterization and biologic therapies.
• Hands-on experience with capillary electrophoresis techniques.
• Hands-on experience with liquid chromatography methodologies.
• Experience troubleshooting and maintaining HPLC/UPLC instrumentation.
• Proficiency with Empower software, including instrument method development and related functionality.
• Data analysis and interpretation skills.
• Technical writing skills for protocols, reports, and scientific documentation.
• Strong communication and presentation skills.
• Ability to work effectively in a collaborative, team-oriented environment.
• Experience working in a GMP-regulated environment (preferred).
• Experience supporting regulatory submission activities (preferred).
• Familiarity with analytical method optimization and troubleshooting (preferred).

Pay

$25.00 - $27.00/hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law.

Benefits

• Medical, dental, and vision benefits.
• Health savings accounts with qualified medical plan enrollment.
• 10 paid days off, 3 days paid bereavement leave.
• 401(k) plan participation with employer match.
• Life and disability insurance.
• Commuter benefits.
• Dependent care flexible spending account.
• Accident insurance, critical illness insurance, hospital indemnity insurance.
• Accommodations and reimbursement for work travel.
• Discretionary performance or recognition bonus.
• Sick leave and mobile phone reimbursement provided based on state or local law.