Principal Analytical Chemist - 0QK3990641
DESCRIPTION/RESPONSIBILITIES:
The Principal Analytical Chemist responsibilities include developing, documenting, and validating reproducible analytical methods for the intended purposes and further expanding the company’s analytical capabilities. They will also be responsible for updating/transferring current commercial QC analytical methods for efficiency as needed. The position also includes working closely with the R&D Synthetic Chemists to improve the understanding of chemical reactions and solve problems encountered during synthesis route selection, process development and scale-up to improve products and processes for New Product Introduction (NPI) and process improvement projects. They will also collaborate with Engineering and QC departments managing analytical project timelines and deliverables
Essential Functions:.
* Assists management in building an inclusive environment where team members are engaged, motivated, and increasing their analytical skills, knowledge, and analytical method development and validation capabilities in a regulated environment (ISO 13485).
* Collaborates with Laboratory Manager on the preparation of proposals for developing and validating new analytical methods. Manage analytical project timelines and deliverables and provide updates on progress made and challenges encountered. Keeps Laboratory Manager informed of challenges that would have an impact on the timeline and serves as key solution driver to overcome these issues.
* Provides leadership and guidance to the Analytical R&D team members developing and validating cGMP analytical methods, and analyzing samples using LC-MS/DAD, GC-MS/FID, NMR, GPC, FTIR, TGA, DSC, Viscometers, Karl Fischer, UV-VIS, etc.
* Assist with maintenance and troubleshooting of analytical lab equipment to minimize downtime. Daily maintenance may include daily verification, repair, preventive maintenance, calibration, etc.
* Independently write well-organized method development reports and method validation protocols and reports as well as mentoring the Analytical Chemists on the development of their per projects assignments.
* Employ sound and compliant laboratory techniques and logic per industry standards (e.g., FDA, USP/NF, ISO, EP, ANSI) and internal and customer requirements for analytical method developments and validations. Guides Analytical Chemists on how to apply these on their own assigned projects.
* Provide training and guidance for new methods being implemented or transferred to the QC team.
* Communicate with customers to help determine appropriate analyses for their products, refine analytical methods, and provide results in reports and presentations.
* Identify, and recommend the purchase of instruments that further expand the team’s ability to understand reactions and increase the company’s product characterization capabilities.
* Communicate with equipment providers to select and purchase new instruments, refine analytical methods, schedule service, and troubleshoot equipment issues.
* Maintain a safe, clean, and organized environment in the R&D analytical laboratory.
* Serves as Laboratory Manager designee for approval, related investigations, protocols, reports, procedures, and instructions.
Qualifications
Education Required: Graduate Degree (Master's or PhD
* Master’s degree in Analytical Chemistry, plus 5 years of industrial experience.
* Ph.D. degree in Analytical Chemistry, plus 2 years of industrial experience.
Certification(s):
Six Sigma or related certification preferred.
Computer Skills Required:
Proficient with Agilent & Waters LC & GC software (ie. Empower, Open Lab, Chem Station, etc.), Microsoft Word, Excel, PowerPoint required.
Other qualifications:
* Five plus (5+) years of experience developing and validating analytical methods in an ISO 9001/ISO 13485 or FDA GMP regulated environment required.
* At least 2-3 years of proven leadership abilities, training, coaching/mentoring, Analytical Chemists developing and validating analytical methods. Ability to solve problems through chemistry knowledge, literature searching, and discussions with other team members.
* Strong knowledge of analytical equipment, analytical methods, method validation and data analysis required. Must have hands on experience working with at least 3 different cGMP analytical methods and analyzing samples using a variety of computerized analytical equipment.
* Knowledge of compendial methods (ie. USP, EP, ISO, ASTM) and ICH guidelines application required.
* Excellent communication skills with the analytical team, and other internal teams required. Team organization and motivation skills and experience required. Must be able to prioritize multiple tasks and projects per business needs.
* Experience working directly with customers is preferred.
What We Offer
Culture
Great people
Peer to Peer Recognition
Broader, hands-on work experience
Clean and Modern Equipment & Labs
Fun company events
Competitive Wages & Generous Year-end Bonus
Comprehensive Benefits
4 Medical PPO Medical Plans with Telemedicine, Rx, & Vision
2 Dental Plans
Healthcare, Dependent care, & Commuter Flexible Spending Accounts
401(k) with company match
Financial Health & Wellness w/1:1 Coaching
Basic & Supplemental Life Insurance
Accident, Hospital Indemnity, & Critical Illness
Paid Time Off
Short & Long-term Disability
9 Paid Holidays
Must have legal authorization to work in the US and will not require sponsorship.
Polysciences is an equal opportunity employer. Drug-free workplace. Tobacco-free work site.
Polysciences does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit and business need.
Equal access to programs, services, and employment is available to all persons. Those applicants requiring reasonable accommodation to the application process and/or interview process should notify a representative of the Human Resources Department.
