TUV SUD is looking for a Senior Chemist in Chemical Characterization (Extractable & Leachable) to work in and help establish a brand new 20,000 sq ft medical device testing laboratory, with collaboration across a global network of labs. This position will contribute to establishing a new chemical characterization lab spanning from the operating procedures to the culture of the group. The Senior Chemist will be focused on GCMS analysis in a fast-paced environment evaluating medical devices according to ISO 10993 under the accreditation requirements of 17025, GLP/GMP requirements and other applicable guidelines. The ideal candidate has a strong extractable and leachable laboratory background, as well as excellent client service, project management, quality system and people leadership skills. International travel may be required for initial training. 

Responsibilities:

- Will routinely perform advanced analytical analyses related to chemical characterization including method development, method validation, feasibility assessments, and sample analysis for various GC techniques including headspace, FID, MSD projects.

- Operate and maintain GCMS systems (and potentially other instruments), including instrument maintenance and troubleshooting.

- Perform/extract samples (solid/liquid, liquid/liquid extraction, concentration)

- Assist with execution of equipment installation, qualifications, and validations.

- Assist in the development of the laboratory quality, compliance, and laboratory support systems including SOP writing

- Collaborate and clearly communicate with cross-functional teams and clients to ensure client's needs are met

- Training and mentoring of other laboratory chemists

- Contribute to continual lab improvements including new method development and improvement of existing methods

Qualifications:

- Minimum BS/BA in chemistry or related field with at least 4 years of relevant experience. MS/PhD 2 years relevant experience

- Previous experience with method development and method validation of analytical methods

- Strong working knowledge of industry regulations (ISO 10993 series of standards, ISO 17025, ISO 13485, and GLPs)

- Ability to organize and track multiple projects in a detail-oriented

- Ability to work and be effective with minimal supervision

- Ability to prioritize and execute on daily project tasks

- Strong organizational skills required

- Exhibit excellent written and oral communication skills and be a proactive, collaborative team player

- Self-starter with a positive and motivated attitude

TÜV SÜD America, Inc. is an equal opportunity, affirmative action employer and considers qualified applicants for employment without regard to race, color, creed, religion, ancestry, marital status, genetics, national origin, sex, sexual orientation, gender identity and expression, age, physical or mental disability, veteran status and those laws, directives, and regulations of Federal, State, and Local governing bodies or agencies. We participate in the E-Verify Employment Verification Program.

For more information on applicable equal employment regulations, please refer to the following:

EEO is the Law Poster: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law Poster Supplement: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf