Method Development Chemist

About the role

Develop, validate, and implement analytical methods for complex chemical and biologic compounds, with a focus on biologic drugs such as peptides, biomolecules, enzymes, and antibody drug conjugates. This role combines hands-on laboratory analysis, advanced data interpretation, and technical leadership to ensure high-quality, compliant results that meet laboratory benchmarks and turnaround time expectations.

Responsibilities

• Develop and validate analytical methods for biologic drugs, including peptides, biomolecules, enzymes, and antibody drug conjugates, as well as traditional chemical compounds.
• Perform routine and non-routine analysis in analytical laboratory departments using appropriate instrumentation and methodologies.
• Provide guidance and troubleshooting support to routine analysts on analytical methods, instrumentation issues, and methodology questions.
• Review, interpret, and approve analytical data independently, ensuring accuracy, reliability, and compliance with laboratory standards.
• Write, review, and maintain Standard Operating Procedures (SOPs) and Standard Test Procedures (STPs) to support analytical activities.
• Enter data accurately into laboratory systems and documentation tools, maintaining clear and complete records.
• Identify, investigate, and resolve instrument and analytical problems, recommending and implementing process improvements.
• Lead or conduct quality assurance (QA) investigations independently, documenting findings and supporting corrective and preventive actions.
• Work independently on complex analytical challenges, providing insight and recommendations for problem solving and method optimization.
• Set up new instrumentation and procedures for specialized or non-routine analyses, including method transfer and implementation.
• Oversee the operation of laboratory equipment, including monitoring supply levels, coordinating repairs, and ensuring instruments remain in good working condition.
• Stay current with new and emerging analytical methods, technologies, and best practices relevant to biologic and chemical analysis.
• Perform statistical analyses on quality control samples to confirm compliance with established specifications and quality standards.
• Ensure the quality and quantity of work consistently meets established laboratory benchmarks and performance metrics.
• Follow all safety requirements in the laboratory, including appropriate use of safety glasses, gloves, lab coats, and other protective equipment.
• Ensure IDC sample requirements and other internal sample handling standards are met in a timely and compliant manner.
• Adhere to all company procedures, policies, and regulatory guidelines in daily laboratory operations.
• Participate in ongoing laboratory skills inventory and training activities to maintain and enhance technical competencies.
• Manage workload to achieve required turnaround times for analyses and reports while maintaining high quality standards.
• Collaborate effectively with colleagues across the laboratory, sharing knowledge and supporting a team-oriented environment.

Requirements

• BA/BS degree in chemistry or a related science field.
• 3–5 years of experience in analytical chemistry, preferably with hands-on HPLC and method development.
• Proven experience in analytical method development and validation, ideally for biologic drugs rather than only small-molecule pharmaceuticals.
• Strong background in peptide chemistry, biomolecules, enzymes, and antibody drug conjugates.
• Demonstrated ability to perform routine and specialized analytical testing in a laboratory environment.
• Strong analytical and problem-solving skills, with the ability to interpret complex data independently.
• Ability to interact effectively with staff at all levels and communicate technical information clearly.
• Effective time management and organizational skills, with the ability to handle multiple projects simultaneously.
• Strong verbal and written communication skills for documentation, reporting, and SOP/STP preparation.
• Ability to work both independently and collaboratively in a team environment.
• Capability to make sound decisions quickly and effectively in a fast-paced laboratory setting.
• Proficiency with Microsoft Office applications for data handling, reporting, and documentation.

Additional Qualifications

• Advanced degree in chemistry or a related scientific field is preferred but not required.
• Experience with method development and validation specifically for biologic drugs, including peptides and complex biomolecules.
• Familiarity with statistical analysis of quality control samples and application of statistical tools to assess method performance.
• Experience writing and reviewing SOPs and STPs in a regulated or quality-focused laboratory environment.
• Background in instrument troubleshooting, maintenance coordination, and process improvement initiatives.
• Comfort working with cross-functional laboratory teams and providing mentorship or guidance to routine analysts.
• Knowledge of general laboratory safety practices and compliance requirements.

Work Environment

This position is based in a laboratory environment, working with analytical instrumentation and equipment to test chemical and biologic compounds. The standard schedule is Monday through Friday, 8:00 a.m. to 5:00 p.m. The role involves regular use of safety glasses, gloves, and lab coats in accordance with safety requirements. Work is hands-on at the bench, with significant time spent operating and overseeing analytical instruments, managing samples, and documenting results in a structured, quality-driven setting.

Pay

The pay range for this position is $33.65 - $43.27/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital insurance
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Schedule

Monday through Friday, 8:00 a.m. to 5:00 p.m.