Lead Chemist

Position Overview: Lead Chemist

We are seeking an experienced Lead Chemist to join our laboratory team. This position is critical within our cGMP manufacturing facility, where you will play a key role in ensuring the quality and reliability of our pharmaceutical products. The Lead Chemist will not only conduct advanced analytical testing but will also lead method development and validation efforts, as well as oversee laboratory operations to maintain compliance with regulatory standards.

In this role, you will have the opportunity to implement and uphold best practices in analytical chemistry, contribute to continuous improvement initiatives, and mentor junior laboratory staff. As a leader within the laboratory, you will be expected to collaborate closely with other departments, including production and quality assurance, to forecast analytical needs and ensure timely delivery of results that meet both production schedules and regulatory requirements.

Qualifications:

● Minimum of a Bachelor’s Degree in Chemistry or a closely related discipline.

● 5 years of experience in a cGMP/cGLP environment.

Important Skills and Competencies:

● Analytical Proficiency

- Extensive experience with chromatographic techniques such as High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC).

- Strong understanding of spectroscopic techniques, including Ultraviolet (UV) and Infrared (IR) spectroscopy.

- Ability to perform Total Organic Carbon (TOC) analysis, particularly in the context of cleaning validation.

● Method Development and Validation

- Expertise in developing robust analytical methods tailored to specific product requirements.

- Proven experience in validating analytical methods in accordance with regulatory guidelines to ensure accuracy, precision, and reproducibility.

- Knowledge of statistical analysis tools for data interpretation and method optimization.

● Instrumentation Skills

- Familiarity with a range of laboratory instrumentation, including troubleshooting, calibration, and routine maintenance.

- Ability to assess and improve instrument performance, ensuring adherence to operational standards.

● Regulatory Knowledge

- In-depth understanding of cGMP and cGLP regulations as they pertain to laboratory operations.

- Experience with regulatory audits and the ability to maintain compliance documentation.

● Problem Solving and Critical Thinking

- Strong analytical and problem-solving skills to identify root causes of issues, particularly during Out Of Specification (OOS) and Non-Conforming Material Reports (NCMR).

- Capability to devise and implement corrective and preventive actions based on investigation outcomes.

● Leadership and Team Collaboration

- Proven leadership skills to effectively manage and mentor laboratory personnel, fostering a culture of continuous learning and improvement. - Ability to communicate clearly and effectively across departments to ensure alignment on analytical needs and priorities.

● Project Management

- Strong organizational skills to prioritize multiple laboratory analyses, balancing production demands with regulatory requirements.

- Experience in project management principles to oversee method validation and laboratory initiatives.

● Interpersonal Skills:

- Excellent communication skills to convey complex scientific information to both technical and non-technical stakeholders.

- Ability to foster a collaborative team environment that emphasizes mutual respect and accountability.

● Continuous Improvement Mindset:

- A proactive approach to identifying areas for improvement within laboratory processes and methodologies.

- Commitment to staying current with advancements in analytical chemistry techniques and regulatory changes.

Full-Time Benefits:

● Comprehensive Dental, Health, and Vision Insurance.

● Paid Time Off and Holidays.

● 401(k) Plan with limited matching.