Description

Polysciences technical operations and scientific laboratories offer custom synthesis, contract manufacturing and packaging, and laboratory products. We are proud to offer a broad range of products and tailored solutions for the life sciences, bioprocessing, microparticles, medical device, specialty chemical and eChem industries. We adhere to ISO13485:2016, FDA cGMP 21 CFR 820 regulations, and SOCMA's ChemStewards® Management System. We believe the best scientific innovations are built through collaborations.

The Senior Analytical Chemist primary responsibility is independent development of analytical methods that are suitable for validation and preparing for validation by drafting Test Methods, method validation or verification protocols with ICH, USP and other regulatory standards in mind. Other responsibilities also include: execution of method validations or verifications, drafting of method validation or verification reports, transferring validated test methods via hands-on training to the Quality Control department, routine testing following established Test Methods, updating Standard Operating Procedures to improve lab functions, perform troubleshooting on Analytical R&D laboratory equipment, review of colleague's laboratory notebooks, and investigation into materials and/or processes to support other Polysciences' departments. The ideal candidate will be quality-focused, collaborative and capable of mentoring or training junior team members in areas of expertise.

Essential Functions:

• Develop new analytical methods for its intended use.
• Verify, validate, and transfer analytical methods to the QC as required for business need
• Perform testing of raw materials, in-process, intermediates and finished product samples according to compendial, internal or customer provided methods and compare results to internal or customer specification
• Aid in maintaining efficient turnaround time of analysis to support NPI and business needs in collaboration with cross functional departments. Communicate analytical results to Principal Analytical Chemist and other relevant parties in a timely manner
• Employ sound and compliant laboratory techniques and logic per industry standards to assist in troubleshooting, investigating and resolving analytical challenges through critical analysis. (Assist with maintenance and troubleshooting of analytical lab equipment to minimize downtime.  This will include but is not limit to, maintenance of analytical balances, pH meter, UV-Vis, FTIR, Karl Fischer, HPLC, GC, GPC, LCMS, GCMS, and NMR
• Familiar with ISO or GMP documentation (hard copy and electronic) of analytical results and assurance of laboratory.
• Knowledge with ICH Guidelines and USP Guidelines for Analytical Method Validations.

• Support audit readiness with understanding of FDA and ISO regulations and requirements.

• Maintain a safe, clean, and organized environment (5S) for all Laboratory areas.

• Independent development of methods, supported by literature research, to align with customer specifications and other business needs.
• Independent drafting of test methods, protocols and reports in alignment with USP, ICH and other regulatory best practices.
• Technical review of junior lab member's laboratory notebooks and data.
• Routine maintenance of laboratory equipment, including but not limited to LCs, GCs, NMR, and GPCs.
• Revising current Standard Operating Procedures and internal documentation to support Continuous Improvement.
• Maintain laboratory notebooks and development reports with ALCOA+ in mind.
• Experience with set-up and analysis using GC-MS and LC-MS systems.
• Experience with NMR, ICP-MS and GPC analyses and theory.
• Mentorship of junior lab members.
• 60 85% of day-to-day activities will be in the laboratory.

• Support audit readiness with understanding of FDA and ISO regulations and requirements.

• Maintain a safe, clean, and organized environment (5S) for all Laboratory areas.

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

  3 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 & Rewards

  Basic & Supplemental Life Insurance

  Accident, Hospital Indemnity, & Critical Illness

  Paid Time Off

  Paid Parental Leave

  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.

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Requirements

Qualifications

Education Required: Bachelor's Degree                                               Preferred: Graduate Degree (Master's or PhD)                           

• Bachelor's Degree in Chemistry, plus 4+ years of industry experience with at least 3 years of experience developing analytical methods or independently validating analytical methods or
• Master degree in Analytical Chemistry, plus 1+ years of industrial experience developing analytical methods or performing validation activities or
• Ph.D. degree in Analytical Chemistry, plus experience developing analytical methods or performing validation activities.

Computer Skills Required: 

Required: Proficiency with Microsoft Word and Excel. Proficiency with at least one of the following: OpenLab, Empower, MNova or Astra.

Other qualifications:

• Experience working in an ISO or FDA regulating environment.
• Experience verifying and troubleshooting analytical methods in an ISO 9001/ISO 13485 or FDA GMP regulated environment required.
• Knowledge of compendial methods (ie. USP, EP, ISO, ASTM and or ANSI) and ICH guidelines and applications.
• Experience mentoring junior lab members.

Immediate Work Environment:

X  Chemicals                   Unprotected Height           X Fumes/Gases           Persistent Noise

X PPE used: eye protection, nitrile gloves, lab coat

Work Activity: (must equal number of hours worked per day)                   

Stand:     3            Frequency:  Intermittently                           Walk:     1            Frequency:  Intermittently    

Sit:         4            Frequency:  Intermittently                           Drive:      0            Frequency:  Choose an item.

Lift/Carry Demands

Frequency:                                                        Lift/Carry Equipment Provided:

0-10 lbs.                Less than 1 hour a day                      Click or tap here to enter text.

11-25 lbs.             Not Daily                             Cart

26-50 lbs.             Rarely                   Click or tap here to enter text.

51-75 lbs.             Never                    Click or tap here to enter text.

76-100 lbs.           Never                    Click or tap here to enter text.