Toxikon Corporation, founded in 1977, is a contract research organization and testing company located in Bedford, MA. Our mission is to provide quality pre-clinical product safety and efficacy testing services, competitively priced, with on-time delivery for the medical device, pharmaceutical, and biotechnology industries.
The Analytical Chemistry Laboratory Manager will report to and work directly with the Department Head of Analytical Services, in conjunction with laboratory operations personnel and interface with sales and customer service.
Essential Duties and Responsibilities:
- Providing technical expertise in supporting preclinical testing per various regulatory requirements, including US FDA, EMA, and others
- Supervise work flow and project manage to requirements of each client/project, assist in optimizing automation of processes, ensure project timelines are met, as well as identify, develop, and oversee continuous process improvements to maximize quality and efficiencies in the laboratory.
- Provide guidance in trouble shooting various analytical instruments such as; HPLC, GC, GC/MS/MS, ICPMS, and others, and interface with Metrology and Validation services on all equipment both existing, and onboarding of new instruments.
- Work with Study Directors regarding study requirements, protocol generation and provide assistance in data review and reporting.
- Write, review, and update SOPs
- Manage and assign inventory management of all laboratory supplies and chemicals, and disposal requirements per the corporate H&S program
- Review and assist Study Directors and Quality Assurance Unit in closing out protocol amendments, deviations and work to ensure compliance with all applicable regulatory guidelines.
- Manage laboratory personnel to ensure project deadlines are being met and technical work is being completed to standards.
- Perform reviews and generate personnel development plans.
- Interface and support the Sales organization, as required, and communicate with clients on related projects.
- A minimum of Bachelors or Master's degree in Analytical Chemistry/Ph.D. preferred.
7-10 years bench level analytical chemistry experience, with at least 3 years demonstrated laboratory
Other Desirable Skills and Experience:
- Excellent verbal and written communication skills
- Strong personal initiative
- Proficiency in Agilent systems, including Open Lab
- High degree of attention to detail and accuracy-corporate compliance
- Must have a solid working knowledge of GLP regulations in an analytical laboratory setting.
- · Exceptional oral and written communication skills
- · Ability to work in a high volume, fast paced environment.
- · Successful leadership and management experience is required as well as a familiarity with the preclinical process, including method development and validation.
- This position is located in Bedford, MA.
For additional information about Toxikon, please visit www.toxikon.com
Toxikon offers a comprehensive benefits program including: paid vacation, sick and personal time, 401(k) plan with company match, medical, dental, vision care, life insurance, short and long-term disability insurances, flexible spending accounts, employee assistance program, employee referral bonus, discount programs and more.
Toxikon is an equal opportunity employer. As an equal opportunity employer we do not unlawfully discriminate against any applicant because of race, sex, gender, ethnicity, religion, creed, age, color, military/veteran status, genetic condition or information, Family and Medical Leave entitlement, sexual orientation, gender identity, national origin, ancestry, marital status, qualified physical or mental disability, transgender status, or any other legally protected class in accordance with federal, state and local laws.