Chemistry Technical Manager – Melville NY

Chemistry Technical Manager

Location : Melville, NY (Relocation available depending on experience and situation)

Opportunity: Direct Hire

Salary Range: $90,000.00 To $100,000.00 Annually

Kelly Science and Clinical is hiring a Chemistry Technical Manager in Melville NY for one of our clients who is a leading provider of laboratory testing, regulatory consulting, and certification & audit services. Our client provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, nicotine, cannabis, and hemp industries.?

JOB SUMMARY

Develop, apply and maintain quality standards for sample testing process, documents, methods and procedures that comply with cGMPs, GLP, 21 CFR, ICH, Monograph, ISO and FDA regulations and guidelines. Schedule frequent meetings with top management to deliver presentations, protocols, reports, and all other data to keep them current on all projects and equipment schedules.

ESSENTIAL RESPONSIBILITIES

Follow and implement all management related activities within the internal SOPs (QSD, GEN and COP) as they pertain to the laboratory and R&D/Validation tests.

This position requires the capability of working in cross-functional teams and to achieve departmental goals.

Ensure processes related to the department are being followed by laboratory personnel. (e.g. Good documentation practices, Good Laboratory Practices, internal SOPs as they apply to the lab).

Provides technical expertise for customer inquiries.

Act with impartiality and work in accordance with the Chemistry Laboratory and management.

Act in a way to not be influenced by particular perspectives, value judgments, community bias, or personal interests that could compromise impartiality.

Communicate possible impartiality risks to management from the Chemistry Laboratory operations to Quality Assurance and/or Management.

Assist in writing, revising, and approving standard operating policies and procedures for the laboratory.

Assist in writing, revising, and approving all method and form updates including associated documents including forms.

Participate in maintenance and improvement of training modules for operation of instrumentation, performing testing, recording, evaluating, and reporting quality data.

Participate in the maintenance of the training program and help to ensure results in effective and efficient training.

Participate in maintaining and establishing organizational policies and operating procedures for the laboratory in a technical capacity.

Manage Department PT program and results as per SOP.

Keep abreast of all regulatory procedures and changes that pertain to the laboratory.

Manage prevention or mitigation of issues in new and/or existing methods.

Manage R&D, Validation, and optimization laboratory testing services. Ensure customer satisfaction, by laboratory communication to customers providing clear testing TAT’s when available and timely updates when schedule for testing is not certain.

Ensure adherence to method validation, verification and transfer processes are followed as pe the SOPs.

Manage the dashboard for overall quantity and quality of testing services provided and performed by the laboratory and interact with your direct management to ensure facility they are aware of requested resources required to support testing needs.

Participate in external and internal, regulatory, and other audits when needed.

Recommend response to laboratory related complaints, considering test reports and records, legal standards, and complaint validity.

Must be able to operate/maintain equipment, including preventive maintenance of laboratory instruments and safety equipment.

Maintain a high degree of technical competence, may attend professional conferences and seminars for information on techniques and instrumentation.

Responsible for working alongside the Safety officer/committee to ensure employees are following safe work practices in the laboratory.

MINIMUM QUALIFICATIONS

Minimum of a Baccalaureate Degree is required; concentration in Biological or Chemical Science and a Masters or higher degree is preferred.

A minimum of ten (10) years in the cosmetic, pharmaceutical, or related field, and four (4) years of regulatory, quality control, or quality assurance experience or equivalent is preferred.

Must have a general working knowledge of 21 CFR, USP/NF, EP, JP, AOAC, ICH, GxP, cGMP, cGLP and/or ISO standards and guidelines.

Must have the ability to communicate clearly in English, both orally and in writing, with scientific and non-scientific personnel is required.

Must have the ability to communicate effectively and solve complex problems.

Must have the ability to communicate clearly in English, both orally and in writing, with scientific and non-scientific personnel is required.

Must be proficient in using Windows programs, Access, Acrobat, Chromeleon, Qtegra, Omnic, ValPro, Data Logger Software, Sievers DataPro2, and Insight with the ability to access, input, and retrieve information using a computer.

Must be able to lift and move heavy items in the laboratory (glassware, solvent bottles, equipment, etc.).

Must be able to work efficiently under pressure and successfully function in a fast-paced environment.

PHYSICAL DEMANDS

Dexterity of hands and fingers to operate a computer keyboard, mouse and to handle other communications/computer components

Potential exposure to odors, fumes, airborne particles, hazardous chemicals, and microbiological pathogens

Noise level varies from quiet to loud

Temperature varies from hot to cold

Interactive and fast-paced team-oriented tasks

Overnight Travel is required at the discretion of management

Occasionally lift and/or move up to 25 pounds.

Color vision and depth perception

BENEFITS:

Progressive 401k Retirement Savings Plan

Employer Paid Short- Term and Long-Term Disability, and Life Insurance

Group Medical

Tuition Reimbursement

Flexible Spending Accounts

Dental

Paid Holidays and Time Off

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.
Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.