Group Leader - Lab - HPLC - GC - Dissolution

PPD

(Waltham, Massachusetts)
Full Time
Job Posting Details
About PPD
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations.
Responsibilities
* Provides management and direction to laboratory staff and resources for project activities and needs, oversee daily operations to monitor quality and project timelines, and assist in preparation and implementation of company policies, quality systems and training programs. * Ensures responsiveness to the customer and overall, client satisfaction. * Plans and monitors the progress and quality of projects by utilizing the financial and quality management tools available at PPD. The roles will be primarily focused on analysis of small molecule drug substances, drug substance intermediates, and drug products (solid oral dosage forms as well as sterile products). The work will involve both cGMP and non-GMP analysis using a suite of analytical methodologies, including: * High performance liquid chromatography * Gas chromatography * Dissolution * Water content by Karl Fisher Disintegration * Tablet hardness * Friability * Vibrational spectroscopy (e.g. infrared and Raman) * Particle size by laser diffraction * Surface area * Differential scanning calorimetry Laboratory data and notebook review as well as authorship of protocols, reports, and data trending tables / plots will also be integral parts of the job function.
Ideal Candidate
**Education and Experience:** * Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 5 years) or equivalent and relevant combination of education, training, & experience. * 1 year of leadership responsibility **Knowledge, Skills and Abilities:** * Proven leadership skills * Ability to cultivate a collaborative work environment with a team * Effective negotiating skills * Demonstrated knowledge of QA metrics of program base; ability to write and recommend changes to PPD SOPs * Ability to troubleshoot multiple systems/methodologies * Ability to independently optimize analytical methods * Understanding of basic financial terms and definitions as it applies to the business * Understanding of proposal and project scope as it relates to pricing, resource management and the impact on business * Project and time management skills * Effective written and oral communication skills as well as presentation skills **Physical Requirements:** * Frequently stationary for 6-8 hours per day. * Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. * Occasional mobility required. * Occasional crouching, stooping, bending and twisting of upper body and neck. * Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. * Ability to access and use a variety of computer software developed both in-house and off-the-shelf. * Ability to communicate moderately complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. * Frequently interacts with others, relates sensitive information to diverse groups. * Ability to apply basic principles to solve conceptual issues. * Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. * Regular and consistent attendance.

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