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Lead Analytical Chemist

2 months ago

Mooresville, North Carolina, United States SCN BestCo Full time
Job Overview
The Lead Analytical Chemist is responsible for conducting qualitative, quantitative, and instrumental assessments of raw materials, stability, in-process, and finished products.

This role involves maintaining a comprehensive understanding of processes and products while spearheading testing initiatives, corrective measures, and departmental projects.

The Lead Analytical Chemist also provides training to colleagues and serves as a subject matter expert (SME) in organizational systems, methodologies, and scientific approaches.

Key Responsibilities
- Oversee testing initiatives, departmental projects, and act as an SME in organizational systems, methodologies, and scientific approaches.
- Identify science-driven opportunities for ongoing enhancement of current laboratory processes, ensuring that laboratory performance aligns with technological advancements and analytical strategies.
- Conduct and lead advanced chemical and physical testing on raw materials, in-process, and finished products.

- Set up, calibrate, maintain, and operate laboratory equipment including Fourier transform infrared spectroscopy (FTIR), spectrophotometer, refractometer, pH meters, high-performance liquid chromatography (HPLC), gas chromatography (GC), flame atomic absorption (Flame AA), and inductively coupled plasma mass spectrometry (ICP-MS).

- Perform product evaluations based on specific product requirements: API analysis, excipients, matrices, supplements, colors, blends, flavors, etc.
- Maintain, review, and update work instructions and Standard Operating Procedures (SOPs).
- Provide guidance and support to technologists and lab assistants with in-process control, sampling, and hold programs.
- Mentor chemists, technologists, and lab assistants while offering technical support and advice.
- Assist with other laboratory functions as needed.
- Collaborate with cross-functional teams, including Research & Development, production, and regulatory affairs.
- Investigate out-of-specification (OOS) results, perform root cause analysis, and implement corrective actions.
- Lead investigations into deviations, CAPAs (Corrective and Preventive Actions), and change controls.
- Ensure compliance with Good Manufacturing Practice regulations as well as all relevant work instructions and SOPs.
- Drive process optimization and efficiency improvements within the Quality Control department.
- Oversee and participate in laboratory equipment qualifications, scheduled preventative maintenance, and troubleshooting.
Qualifications
Education & Experience:
- Bachelor's degree in chemistry or a related field.
- 8 years of relevant professional experience.
Knowledge, Skills, & Abilities (KSAs):
- Proficient in Microsoft Office, particularly Excel, and familiar with laboratory information management or laboratory execution systems (LIMS/LES).
- Strong technical writing capabilities and the ability to create comprehensive technical documentation.
- Ability to interpret and apply Good Manufacturing Practice (GMP) regulations.
- Excellent analytical, decision-making, technical, organizational, planning, and written communication skills.
- Competence in performing calculations involving proportions, percentages, area, circumference, and volume, as well as applying basic algebra and geometry concepts.
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals, and to write routine reports and correspondence.
- Ability to effectively communicate in group settings.
- Ability to apply common sense understanding to execute instructions provided in written, oral, or diagram form, and to address problems involving several concrete variables in standardized situations.
Preferred Qualifications
- Master's degree in chemistry or biochemistry.
- Certified training in relevant instruments or techniques.
- In-depth understanding of LIMS/LES systems and their limitations.
- Extensive technical knowledge of instrumental analytical software (GC, HPLC, FAA, platforms).
Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The employee is occasionally required to walk, sit, reach with hands and arms, climb or balance, taste and smell, lift or carry items up to 25 pounds, and push or pull items up to 10 pounds.

The employee must frequently stand and use hands to finger, handle, or feel; and is constantly required to talk and hear.

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually low; however, since this position is located within manufacturing, there may be occasions where increased levels of noise and exposure to particles related to the nature of work.

The position is frequently exposed to toxic or caustic chemicals.
Safety Requirements

All employees are expected to carry out their functions in a healthy and safe manner, to always encourage and support safe work practices, and to report and/or rectify any unsafe conditions that may come to their attention immediately.

All SCN BestCo employees must wear PPE as required based on their job duties.