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)

Position Title: Manufacturing Technician

Position Summary

Performs all functions relating to the processing of drug substances (also known as Active Pharmaceutical Ingredients (API)); consistent with established Current Good Manufacturing Practices (cGMP), Batch Records and SOPs. Responsible for the safe and efficient execution of the job duties, while ensuring product compliance to established standards.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Operates pharmaceutical production machinery, handles chemicals (acids, bases, corrrosive & toxic chemicals) and executes procedures for manufacturing such as dispensing, mixing, reaction, centrifuge, distillation, purification, drying and the like after receiving training. Complete training qualification to operate independently.
• Executes Batch Record and logbook documentation with detail, as steps are completed and with accuracy.
• Executes the procedures used to operate and clean pharmaceutical production equipment and facilities.
• Executes changeovers and line clearances, ensuring equipment and facilities are free of product and any contamination.
• Maintains production reporting for assigned work unit operation.
• Performs required in-process product quality checks and documents accurately.
• Executes procedures to complete tasks in a safe, quality-minded and efficient manner.
• Works with integrity, transparency and in collaboration with others as part of a team.
• Effectively communicates issues to supervisor and always maintains integrity and transparency.
• Adheres to all cGMPs, compliance/regulatory mandates, quality and safety requirements.
• Assists in the identification and implementation of continuous improvement opportunities.
• Performs other related duties as assigned to meet departmental and Company objectives.

Qualifications

Must be capable of working various hours/shifts, and weekends when necessary. A strong background in Pharmaceutical API manufacturing or education in STEM is a plus.

KNOWLEDGE/SKILLS/ABILITIES

• Knowledge of Metric and English weighing and measurements systems.
• Basic understanding of mechanical machinery and the operating principles of control systems.
• Demonstrated mathematical ability in addition, subtraction, multiplication, division, ratios and percentages.
• Ability to use a calculator.
• Ability to follow both verbal and written instructions including SOP’s and Batch Record documentation.
• Accurate and precise in recording data and batch information.
• Demonstrated ability to work in both independent and team environments.
• Proficient in reading and writing English to understand work instructions and document results.
• Demonstrated ability to operate pharmaceutical processing equipment.
• Demonstrated ability to meet required standards of cGMPs.
• Demonstrated understanding of the unit operations and the ability to assist with on-the-job training of manufacturing trainees and operators.

EDUCATION/EXPERIENCE

• Student pursuing Undergraduate degree in STEM preferred.
• High school diploma or general education diploma (GED) with two years’ related experience or equivalent technical training/certification preferred; or a combination of related experience and technical training/certification.

Additional Information

WORK ENVIRONMENT
The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:
1. Stand, walk, sit, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, and hear.
2. Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
3. Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck to lift, carry, push, pull or otherwise move objects.

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:
1. Sufficient noise to occasionally cause the individual to shout in order to be heard above the ambient noise level.
2. Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.
3. Atmospheric conditions sometimes expose individual to dust, for which protective equipment is available.
4. Individual are required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

All your information will be kept confidential according to EEO guidelines.

Job Type: Full-time

Timing:

• 1st shift timings – 6:00 am to 2:30 pm
• 2nd shift timings – 2:00 pm to 10:30 pm

Wages:

Level I – $19.00 – $21.50

Level II – $21.60 – $25.00

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Health savings account
• Paid time off
• Vision insurance

Work Location: In person

Job Description: Manager Program Management

Position Overview

This role is responsible for managing and supporting strategic programs and workforce initiatives across the organization, ensuring seamless coordination between internal teams and external partners. The position drives project execution, workforce development, and continuous improvement, supporting the company’s growth and compliance objectives.

Key Responsibilities

Project Management

• Develop and manage project charters, timelines, budgets, and resource plans for R&D projects and workforce development.
• Implement program governance, reporting, and risk management practices.
• Align project priorities with strategic business goals.
• Coordinate with procurement team on status of material, equipment and services procurement, and installation in compliance with regulatory guidelines.
• Ensure projects meet safety, quality, and operational standards.

Workforce Development

• Design and implement workforce development programs, including apprenticeship, on-the-job training, co-op project initiatives and internship projects, in coordination with management, related department, external organization and institutions.
• Build strong relationships and timely communications with external organizations and institutions.
• Support with employee reporting and compliance with government programs.
• Represent the organization in external meetings, job fairs, conferences, and collaborative projects.

Internal Coordination

• Support with onboarding new hires, mentoring and coordinating training requirements to ensure compliance to regulations.
• Manage Quality Management System training matrix and employee job profile required for training for the company.
• Monitor training status of employees across all departments and coordinate with department management and quality assurance to ensure timely completion of any training.
• Ensure effective communication and coordination across stakeholders.

Qualifications

• Bachelor’s degree required.
• 8+ years of project management and workforce development experience in pharmaceuticals, biotechnology, or related industries.
• Strong knowledge of regulatory requirements (FDA, cGMP, ICH), quality systems, and laboratory operations.
• Proven leadership, team development, and strategic planning skills.
• Excellent communication, problem-solving, and multitasking abilities.
• Experience with training program design and implementation.

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)

Work Location: In person