Associate Director/Analytical Chemist

Posted on Nov 14, 2018 by Affinity Executive Search

High Point, NC 27260
Research & Development
Immediate Start
Annual Salary
Full-Time
Associate Director in Analytical R&D.

Responsibilities

*

* Manage/coordinate/drive efforts of staff in conjunction with approved quotes and plant scheduling; ensure adherence to agreed-upon deadlines; timely invoicing of work.
* Assure compliant, staffed analytical laboratory support.
* Recommend/justify new/additional equipment, upstaffing or organizational positions, promotions.
* Develop/maintain/improve Analytical Procedures/SOPs/systems/procedures/similar.
* Ensure training, development, and mentoring of laboratory colleagues.
* Represent GMP Analytical in production meetings, customer discussions, etc.
* Lead larger-scope projects.

* _Expectations of Self/Others:_

* Fully capable of developing/qualifying/validating analytical methods based on experience, first principles, sound theory, etc. Must demonstrate insight in design of experiments and gathering/interpreting data in order to deduce and/or test mechanistic or systematic hypotheses
* Design, develop, conduct and/or review experiments including method qualification/validation, method transfer, and unknown identification utilizing typical instrumentation including but not limited to LC, MS, GC, etc.
* Facility and/or experience in first-principle interpretation of results from IR, NMR, LC/MS data (structural elucidation/support to conclusions)
* Use/facility in various instrumental methods (IR, NMR, XRPD, TGA, KF, etc.) as well as non-instrumental methods (wet chemical methods)
* Write reports documenting outcomes of experiments/exercises
* Organize workflow and tasks to maximize laboratory efficiency (e.g., prioritize sample analysis, manage/assign tasks, preventative maintenance)
* Act as scientific, regulatory, technical or quality expert/liaison in team meetings and other settings by providing timely input to project activities/support to customers, responding to targeted questions, etc.;
* Participate in the laboratory quality system activities such as internal audits, writing standard operating procedures, and documentation review;
* Prepare samples for analysis and record data from analyses or experiments in a computer, log book, or laboratory notebook;
* Perform data audits in order to ensure accuracy of data and analytical processes;
* Provide leadership including cross-training and technical development to other laboratory colleagues as needed;
* Maintain laboratory equipment and instrumentation (e.g., troubleshooting, conducting preventative maintenance, calibrating and repairing);
* Ensure compliance with company policies and SOPs as well as FDA and other applicable guidelines.

Minimum Requirements

The successful candidate will hold a PhD or MS in Chemistry (or closely related discipline) with 5+ years of demonstrated success in leading teams and managing projects along with 7+ years relevant analytical experience in a cGMP-compliant pharmaceutical laboratory environment. BS degree may be considered only with exceptional experience. Broad background, strong comprehension, and demonstrated skills in analytical methods development/validation/transfer/similar, reference standards characterization/structural elucidation, and unknown identification.

Other Experience/Skills:

In-depth work experience in an analytical contract laboratory environment is a strong positive. Experience in stability study performance/evaluation and/or knowledge/familiarity with USP/compendial testing is helpful. Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential. Proficiency with Microsoft software (Word / EXCEL / PowerPoint) is expected.

Co.offers Custom organic synthesis, cGMP scale-up, Contract research, Molecular building blocks, Medicinal chemistry services and is a leader in fostering the commercial development of small molecule drug discovery and development in pharmaceutical, discovery platform, and biotechnology companies. The Co.offering parallels the drug discovery process and provides significant advantages at each step from lead discovery to lead optimization, chemical synthesis and scale-up of pharmaceutical intermediates as well as chemical process R&D.

REQUIREMENTS:

The successful candidate will hold a PhD or MS in Chemistry (or closely related discipline) with 5+ years of demonstrated success in leading teams and managing projects along with 7+ years relevant analytical experience in a cGMP-compliant pharmaceutical laboratory environment. BS degree may be considered only with exceptional experience. Broad background, strong comprehension, and demonstrated skills in analytical methods development/validation/transfer/similar, reference standards characterization/structural elucidation, and unknown identification.

Other Experience/Skills:

In-depth work experience in an analytical contract laboratory environment is a strong positive. Experience in stability study performance/evaluation and/or knowledge/familiarity with USP/compendial testing is helpful. Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential. Proficiency with Microsoft software (Word / EXCEL / PowerPoint) is expected.

Reference: 559199081

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