Senior Chemist

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Job description

About ImprimisRx

At ImprimisRx we are working hard to help our customers navigate the realities of the healthcare market by providing innovative medications that address both clinical and economic needs. To get there, we need exceptionally talented, bright, and driven people. If you would like to help us build a quality culture organization trusted by healthcare professionals from across the US, this is your chance to join us. We are looking for a dynamic, organized, self-motivated leader to join our quality control department at our New Jersey facilities. Responsibilities include quality control laboratory activities at our 503B FDA Registered Outsourcing Facility. This position reports to the Quality Control Manager.

Job Summary

This position is responsible for testing of incoming raw materials, in-process products, and finished products in the Quality Control laboratory. Strong background in analytical chemistry. This role provides leadership and technical expertise to assist the laboratory with troubleshooting, investigations, and instrument qualifications. The Senior Chemist may be involved in second verification of data.

Position Responsibilities

* Manage the testing performed by external laboratory for analytical and microbiological methods including but not limited to Chemistry testing, Sterility, Endotoxin Testing, Bulk Bioburden and AET testing.
* Partner with external testing laboratory and manage investigation for out-of-specification laboratory results ensuring that all investigations proceed in a logical, orderly, and timely manner and that appropriate corrective and preventive actions are identified, when necessary, review and approve investigation reports.
* Conducts routine and non-routine chemistry and microbiological analysis of raw materials, in-process products, and final products to established specifications.
* Advanced working experience of deviation investigations utilizing root cause analysis tools.
* Must be able to work independently with limited direct supervision, have demonstrated ability to follow through on multiple projects, and be goal oriented with a strong desire for achievement. Ability to work effectively under pressure to meet deadlines.
* Working experience in the CAPA process and ability to identify and verify effectiveness.
* Advanced technical writing skills on analytical methods, deviations, protocols, SOPs and any other technical documents as required.
* Demonstrate advanced problem-solving ability/mentality, technical adeptness, and logical thinking.
* Initiate change control documentation.
* Operate and maintain analytical instrumentation such as HPLC, GC, FTIR, TOC, UV, etc. and minor trouble shooting of equipment.
* Ensure all investigations are completed in a timely manner. Notify stakeholders of any delays in a timely manner.
* Provide mentorship, guidance, and training to new or existing personnel.
* Ability to handles hazardous materials using all appropriate or mandatory safety PPE and safety equipment.
* Facilitates and supports activities and services necessary to the routine operations of the department, as assigned.
* Verifies results, including but not limited to, calculations in notebooks/logbooks and results in reports to check for accuracy and integrity of data.
* Provides project support for new product development which requires a close working relationship with R&D.
* Participates in inter-departmental task teams.
* Interfaces with peers in other departments, senior management, and regulatory agencies.
* Provides support for ordering and maintaining inventory of laboratory materials and equipment.
* Performs other miscellaneous duties as required.

Requirements

* Minimum BS in Chemistry, Biology, Microbiology, or related sciences. 5 years relevant pharmaceutical laboratory/analytical experience. Experience with common pharmaceutical laboratory equipment including, but not limited to UV, IR, HPLC, GC, TOC, among other instrumentations. Expertise in wet chemistry techniques such as titrations, extractions, and preparations of test solutions. Individual may be required to sit, stand, walk and occasionally lift 0-15 pounds.
* Accountability: Assume responsibility for successfully accomplishing work objectives and delivering business results; setting high standards of performance for self and others
* Agility: Respond positively to change, embracing and using new practices or values to accomplish goals and solve problems
* Creativity: Explore and advances opportunities to develop novel solutions and approaches to the improvement of processes and services
* Empowerment: Find opportunities to improve and extend their contribution to the organization and their teammates
* Integrity: Demonstrate the highest commitment to integrity and showing respect for and value all individuals for their diverse backgrounds, experiences, styles, approaches, and ideas
* Passion: Evidence passion for the organization, our people, and the difference we make daily in improving the lives and health of people
* Attention to Detail: Ensure information is complete and accurate; follow up with others to ensure that agreements and commitments have been fulfilled
* Teamwork: Work well with others while providing support and assistance to team members to help accomplish objectives
* Time Management: Establish a systematic course of action for self or others to ensure accomplishment of a specific objective; set priorities, goals, and timetables to achieve maximum productivity
* Knowledge of the following: Safety and hazardous waste requirements. cGMP standards. Demonstrated history of method development and/or validation. Wet chemistry experience preferred (ex. Acid/Base Titrations, water content). Must have applied working knowledge of various laboratory instrumentation. MS Office (Word, Excel, Access). Strong interpersonal and organizational skills.

Work Environment/Physical Demands

* The employee may frequently be required to sit and talk or hear.
* The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch.
* The employee must occasionally lift and/or move up to 25 pounds.
* Cleanroom environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no makeup or jewelry can be worn when working in the clean room environment.
* Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

AAP/EEO Statement

ImprimisRx believes in creating long-term relationships by being responsive and relevant and by consistently delivering value to our community of customers. Specifically, with our employees, we focus on attracting, developing, and retaining the best talent for our business, challenging our people, demonstrating a "can-do" attitude, and fostering a collaborative and mutually supportive environment.

Diversity creates a healthier atmosphere: All qualified applicants will receive consideration for employment without regard to age, ancestry, race, color, religion, sex, national origin, protected veteran status, disability status, marital status, medical condition, genetic information, national origin, gender (including gender identity and expression), or sexual orientation.

ImprimisRx is a drug-free workplace. Candidates are required to pass a drug test before beginning employment. In addition, employees in certain positions are subject to random drug testing.