- Lead project development by working with Innovation, Production and Marketing departments to ensure deliverables are met.
- Facilitate second review of analytical results.
- Perform and assist with instrument troubleshooting, general/preventive instrument maintenance, and operational qualification of lab equipment.
- Lead analytical tasks associated with product development and communicate progress to the necessary departments.
- Write specifications and standard operating procedures (SOPs).
- Generate protocols and reports.
- Train laboratory analysts during method transfer.
- Maintain a clean, organized laboratory environment.
- Participate in cross-departmental meetings.
- Review and witness laboratory notebooks and provide feedback.
- Design method validation protocols and conduct validation experiments for drug substances and dosage forms.
- Interpret data, draw conclusions, and make recommendations based on the data.
- Bachelor's degree in chemistry or related science.
- 5 years' experience working in a comparable, regulated manufacturing environment.
- Chromatography experience including gas chromatography (GC) and high-performance liquid chromatography (HPLC).
- Familiarity with standard concepts, practices, and procedures within the field of chemistry including solid analytical techniques.
- Solid understanding of cGMPs and GLPs.
- Ability to work independently without close supervision.
- Must be able to work independently and within a team environment.
- Ability to work flexible hours when needed.
- Strong creativity, innovation, customer focus, decision-making, technical, organizational/planning, and written communication skills.
- Must have the ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- Must have the ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.
- Must be able to demonstrate practical problem solving and troubleshooting skills. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Master's degree in chemistry or related field.
- Dissolution, drug impurity method development, and/or method development and validation experience.
- Knowledgeable in ICH guidelines for drug product analysis.
- Understanding of analytical data regulatory submission requirements and quality by design principles.
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Analytical Chemist - Mooresville, NC, United States - SCN BestCo
Description
We believe being healthy should not require tradeoffs. SCN BestCo is a leading innovator, developer and manufacturer of Vitamin, Mineral & Supplement (VMS), Over-the-Counter (OTC) and prebiotics/probiotics in enjoyable forms such as gummies, lozenges and chews. With over 50 years of excellence, our team leads the way in changing how consumers make healthier choices. With unique food science expertise and proprietary processes, we've pioneered many firsts. Our passion to create new to the world products has guided and continues to be core to our mission of making health and wellness more enjoyable. Come join us and become a part of our winning formula
Under the general supervision of the Director, Analytical and Regulatory Affairs of Regulatory Affair and Quality Control, the Analytical Development Chemist is responsible for developing and validating analytical methods, writing and establishing specifications, and performing trial pharmaceutical product testing. The role requires creativity and latitude with the ability to use experience and judgment to plan and accomplish goals.
Essential Duties and Responsibilities
Required Qualifications
Education & Experience:
Knowledge, Skills, & Abilities (KSAs):
Preferred Qualifications
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR c)
