Senior Analytical Chemist

Apicenter; Missouri; Hybrid; USD 60,000 - 100,000; Full time

Job summary

Join a nonprofit organization dedicated to transforming pharmaceutical development as a Senior Analytical Chemist. In this pivotal role, you will lead the development and qualification of analytical test methods for raw materials and APIs, utilizing cutting-edge technologies like liquid chromatography and mass spectroscopy. Collaborate with experts to ensure compliance with federal regulations and Good Manufacturing Practices (GMP). This hybrid position offers a unique opportunity to contribute to innovative pharmaceutical solutions in a dynamic startup environment, where your expertise will directly impact the future of drug development. Be part of a talented team and help shape the future of healthcare!

Benefits

Competitive salary

Benefits package

Startup environment

Opportunity for innovation

Qualifications

• Experience in developing and validating analytical test methods.
• Strong knowledge of FDA regulations and GMP compliance.

Responsibilities

• Develop and qualify analytical test methods for APIs.
• Provide technical leadership and manage method transfers.

Skills

Analytical Chemistry

Test Method Development

Good Manufacturing Practices (GMP)

Liquid Chromatography

Mass Spectroscopy

Documentation Preparation

Education

Ph.D. in Analytical Chemistry

Master of Science in Analytical Chemistry

Bachelor of Science in Chemistry

Tools

Analytical Instrumentation

Process Analytical Technology (PAT)

Job description

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1 year

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Senior Analytical Chemist

The API Innovation Center (APIIC) seeks an experienced Senior Analytical Chemist who will be responsible for developing and qualifying analytical test methods for raw materials, intermediates, and active pharmaceutical ingredients (APIs) being generated in a lab setting. The successful candidate will provide technical leadership, utilizing state-of-the-art technologies such as liquid chromatography and mass spectroscopy to develop stability indicating test methods and acceptance criteria for APIs. This role requires working closely with internal and external experts, managing the transfer of test methods under Good Manufacturing Processes (GMP), and ensuring compliance with federal regulations.

APIIC is a nonprofit public benefit organization headquartered in St. Louis, Missouri, dedicated to revolutionizing pharmaceutical development through innovative chemical and semi-synthetic research. By developing and leveraging advanced manufacturing technologies, APIIC aims to create sustainable and efficient routes for producing vital pharmaceuticals in the U.S. Through investments in and collaboration along the supply chain, APIIC’s model contracts leading U.S.-based specialists within their pharmaceutical ecosystem to develop and manufacture APIs, ensuring high-quality domestically produced pharmaceuticals.

Primary Duties and Responsibilities

• Work closely with internal and external subject matter experts, process chemists, process engineers, and project managers under minimal supervision.
• Provide the technical lead for development and validation of analytical test methods utilizing state-of -the-art technology.
• Work with external subject matter experts and stay abreast of the latest technologies and applicable federal regulations.
• Execute and verify compendial test methods and develop specialized methods to support lab scale and commercial API manufacturing processes.
• Provide technical leadership for transfer of a complete set of analytical test methods to contract manufacturing organizations for manufacturing under cGMPs.
• Preparation and review of relevant documentation including, but not limited to, reports, specifications, and batch records, as well as updating relevant lab records.
• Assists in the creation and submission of Drug Master Files (DMFs).

Personal Characteristics

• Behave Ethically: Understand ethical behavior and business practices and ensure that their own behavior and the behavior of others is consistent with these standards and align with the values of the organization.
• Build Relationships: Establish and maintain positive working relationships with others, both internally and externally, to achieve the goals of the organization.
• Communicate Effectively: Speak, listen, and write in a clear, thorough, and timely manner using appropriate and effective communication tools and techniques.
• Creativity/Innovation: Develop new and unique ways to improve operations of the organization and to create new opportunities.
• Foster Teamwork: Work cooperatively and effectively with others to set goals, resolve challenges, and make decisions that enhance organizational effectiveness.
• Make Decisions: Assess situations to determine the importance, urgency, and risks, and make clear decisions that are timely and in the best interests of the organization.
• Organize: Set priorities, develop a work schedule, monitor progress toward goals, and track details, data, information, and activities.

Preferred Qualifications

• Solid hands-on analytical chemistry skills in developing compendial and novel test methods.
• Experience with test method validation, DMF support, and technical transfers are preferred.
• Work well with other disciplines (safety, process chemists, engineers, and regulatory affairs).
• Track record of high performance in analytical method development from lab to pilot plant and into commercialization, preferably including APIs.
• Experience with successful validation of API test methods and support of DMF submissions.
• Broad organic chemistry knowledge base and understanding of chemical transformations.
• Experience with FDA Q7A Good Manufacturing Practice Guidance for APIs.
• Excellent laboratory skills and good mechanical aptitude.
• Solid understanding of analytical instrumentation and techniques as well as Process Analytical Technology (PAT).
• Ability to work effectively as an individual, within a team, and with internal and external partners.
• Preferred: Ph.D. in Analytical Chemistry with 3 years of related experience, a Master of Science in Analytical Chemistry with 5 or more years of experience or a Bachelor of Science in Chemistry with 8 years of directly related experience.

What We Offer

Be part of an exciting startup environment with a growing and talented team.

Opportunity to contribute to cutting-edge pharmaceutical innovation.

Competitive salary and benefits package.

This is an exciting opportunity to be part of a growing organization at a pivotal moment.

Location:St. Louis, MO. Hybrid position.

Reports to : the Vice President of Research and Development and Programs.

Application Requirements:To apply, please provide a cover letter and resume.

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