Position Title: Research and Development Scientist II
Department: Research & Development (R&D)
Location: 218 Millwell Drive, Maryland Heights, MO 63043
FLSA Status: Exempt

Position Summary

The Research and Development Scientist is responsible for designing, executing, and analyzing experiments to support the development of new products, processes, and technologies. The role involves working on pharmaceutical key starting material, intermediates, active ingredients and drug product formulations development work.

This role involves collaborating with cross-functional teams to transform scientific concepts into practical solutions, ensuring compliance with regulatory standards, and driving innovation within the organization.

Key Responsibilities

• Research & Innovation:
• Develop and test new formulations, compounds, or technologies to meet business and scientific objectives.
• Conduct experiments, collect and analyze data, and interpret results to guide project decisions.
• Build knowledge of current scientific advancements  and stay current on scientific literature, emerging technologies, and competitive products.
• Research and present ideas for new processes, continuous improvement opportunities, new methods, new applications, etc
• Product & Process Development:
• Conduct literature research and work on applying flow chemistry to existing and new molecules
• Translate research findings into scalable manufacturing processes.
• Design and run experiments for new products and processes, make detailed observations, analyze data, record and interpret results, and convey those results in an effective manner.
• Plan and execute design of experiments on product development
• Trending and analysis of development data
• Work on raw materials specifications development
• Proper handling of all chemicals and proper disposal of waste.
• Assist with contract manufacturing when necessary
• Work with vendors on API specifications, characterization and scientific assessment
• Work with pilot production equipment in scale up efforts
• Work on Process scale up work with production team, to improve on-scale processes
• Equipment cleaning validations studies development
• Develop skills in analytical instruments needed for research and development. Develop methods for analysis and characterization
• Optimize formulations, processes, and protocols for efficiency, quality, and cost-effectiveness.
• Support pilot and scale-up activities in collaboration with manufacturing teams.
• Write pharmaceutical development reports
• Develop batch records for development and scale-up
• Regulatory & Compliance:
• Build a sound understanding of pharmaceutical cGMP, and ability to implement cGMP in daily R&D and production activities.
• Ensure all research and development activities comply with applicable regulatory requirements (e.g., FDA, EPA, ISO, GLP/GMP as relevant).
• Prepare and maintain accurate documentation, technical reports, and regulatory submissions.
• Participate in regulatory filings of product dossier
• Collaboration & Communication:
• Work with cross-functional teams (e.g., QA, regulatory affairs, engineering, clinical, operations) to bring products from concept to market.
• Present findings, progress, and recommendations to leadership and stakeholders.
• Contribute to patent filings, publications, and intellectual property development.
• The job will require periodic flexibility in timings to cover R&D, and manufacturing schedule.
• Handle multiple tasks and deadlines
• Special Projects as needed.

Qualifications

Education:

• Ph.D. or Master’s degree in Chemistry, Biology, Biochemistry, Biomedical Engineering, Pharmaceutical Sciences, or related scientific field.

Experience:

• [Ph.D. + 0–2 years] or [Master’s + 3–5 years] of experience in R&D, product development, or applied research
• Prior experience in pharmaceuticals, biotechnology, chemicals.

Skills & Competencies:

• Strong knowledge of experimental design, analytical techniques, and data interpretation.
• Hands-on experience with relevant laboratory equipment, software, and methodologies.
• Excellent problem-solving and critical-thinking skills.
• Strong written and verbal communication, including the ability to draft technical reports and present findings.
• Ability to work independently and collaboratively in a team-oriented environment.
• Project management and multitasking abilities to handle multiple research initiatives.

Working Conditions

• Laboratory and office environment with routine use of specialized equipment.
• May involve handling chemicals, biological samples, or other laboratory materials (with appropriate PPE).
• Some travel may be required to attend conferences, collaborate with external partners, or support field trials.

Career Path & Growth

• Opportunity to progress to Senior Scientist, Principal Scientist, or R&D Manager roles based on performance, expertise, and leadership.

Benefits

• 15 Days PTO plus select national holidays / 20 days PTO after 5 years
• Health insurance (employer and employee contribution) (Eligible on start)
• Vision (employer contribution)
• Dental (employee contribution)
• 401 (k) with 3% employer contribution (eligible after 3 months)
• Short Term and Long Term Disability (employer contribution)

Position Title: Quality Control Analyst II
Department: Quality Control (QC)
Reports To: QC Supervisor / QC Manager
Location: 218 Millwell Drive, Maryland Heights, MO 63043

FLSA Status: Exempt

Position Summary

The Quality Control Analyst II performs intermediate-level laboratory testing and analysis to support raw material, in-process, stability, and finished product testing in compliance with Good Manufacturing Practices (GMP). This role involves executing validated methods, troubleshooting issues, mentoring junior analysts, and contributing to continuous improvement initiatives within the QC laboratory.

Key Responsibilities

• Laboratory Testing:
• Develop and establish proficiency in wet lab, titrators, HPLC, IC, FT-IR, UV and all other lab instruments.
• Perform routine and non-routine chemical, physical, and microbiological testing on raw materials, intermediates, and finished products.
• Perform routine sampling and testing of water systems, raw materials, intermediates and finished drug substances and drug products per established test procedures in a cGMP compliant manner.
• Execute stability studies in accordance with established protocols.
• Accurately record, analyze, and interpret test results to ensure product quality and compliance with specifications.
• Coordinate with third party labs on current and new testing needs and send samples out to third party labs.
• Active participation in laboratory housekeeping and contamination control
• Perform QC inventory as per schedule.
• Participate in method transfers, validations, and qualification of laboratory equipment.
• Documentation & Compliance:
• Maintain detailed and accurate laboratory records in accordance with GMP and company SOPs.
• Review and verify data for accuracy and compliance prior to submission.
• Perform data review of peer QC packets per cGMP guidelines and Sentio procedures.
• Assist in drafting or revising test methods, SOPs, and related documentation.
• Equipment & Troubleshooting:
• Operate, calibrate, and maintain laboratory instruments (e.g., HPLC, IC, UV-Vis, FTIR, dissolution testers, balances, pH meters, polarimeter, colorimeter).
• Identify, troubleshoot, and escalate instrument or testing issues as needed.
• Quality & Continuous Improvement:
• Support investigations of out-of-specification (OOS), out-of-trend (OOT), and deviations.
• Propose and implement improvements to laboratory practices, workflows, and data integrity controls.
• Ensure compliance with internal policies, FDA, ICH, USP, and other regulatory requirements.
• Collaboration & Mentorship:
• Provide training and guidance to junior analysts (QC I level).
• Work closely with cross-functional teams, including Quality Assurance, Manufacturing, and R&D, to support production and release timelines.
• Communicate effectively with team members and management regarding test progress, issues, and results.

Qualifications

Education:

• Bachelor’s degree in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, or a related scientific discipline.

Experience:

• 4+ years of relevant QC laboratory experience in a GMP-regulated environment with 2+ years of HPLC experience.
• Hands-on experience with analytical instruments such as HPLC, FTIR, UV-Vis preferred. Bioburden testing a plus.

Skills & Competencies:

• Strong knowledge of GMP and regulatory testing requirements.
• Ability to analyze data, identify trends, and resolve technical problems.
• Proficiency in laboratory information management systems (LIMS), Empower, or similar software.
• Strong written and verbal communication skills.
• Ability to prioritize workload and meet deadlines in a fast-paced environment.
• High attention to detail and commitment to data integrity.

Working Conditions

• Laboratory environment with exposure to chemicals, reagents, and biological materials (appropriate PPE required).
• Extended periods of standing and handling laboratory equipment.
• May require occasional evening or weekend work to support production schedules.

Career Path & Growth

• Opportunity to advance to Quality Control Analyst III, Senior QC Analyst, or QC Supervisor roles depending on performance, expertise, and leadership contributions.

Benefits

• 15 Days PTO plus select national holidays / 20 days PTO after 5 years
• Health insurance (employer and employee contribution) (Eligible on start)
• Vision (employer contribution)
• Dental (employee contribution)
• 401 (k) with 3% employer contribution (eligible after 3 months)
• Short Term and Long Term Disability (employer contribution)