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Senior Scientific Director

Company name
Precision Medicine Group

Frederick, MD

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Frederick, Maryland, , United States

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Employment Type:

Full time


Job Description

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. 2018 Precision Medicine Group, LLC Exciting opportunity to lead a Scientific Team with a growing business in a high growth industry. Senior Scientific Directorsimplement and create the scientific mission, vision, and overall direction of the Precision laboratory services business. This individual will be instrumental in helping Precision achieve its goals of delivering exceptional services to Precisions diverse, innovative and global biopharmaceutical clients. This includes formulating and implementing a strategic scientific plan to support translational medicine research, primarily, but not solely, in the Immuno-Oncology and autoimmune/inflammatory space. Key components will be focused on, design and development of innovative qualified and validated immunophenotying (including 18 color flow cytometry assays, receptor occupancy assays, tetramer/dextramer assays as well as simpler flow based assays), and antigen specific (ELISPot/Fluorospot) or other cell based assays and molecular assays such as Nanostring. This rolealso has responsibility for delivery of healthy and disease state human primary cells isolated from leukopaks, our Accucell product. Essential duties include but are not limited to: * Lead the development and implementation of scientific services to support the Translational Research needs of Precision customers (e.g. multi-parameter flow cytometry (18 ), antigen-specific cell-based assays, SNP genotyping etc.) * Communicate results effectively to clients and develop lasting relationships to support future work * Design and develop new products and services (e.g. additions to the Accucell line of products such as CD34 cells, standardized and validated flow cytometry panels) * Develop the scientific culture of the organization; leads and develops scientific managers and mentors scientists * Attract exceptional talent and oversee and direct staff training and development * Interact, influence, and collaborate effectively with Precision colleagues and counterparts at other Precision labs * Effectively communicate our capabilities and offerings to the Precision customer community and develop new business opportunities through industry networking attendance and scientific meetings and client presentations * Lead and participate in establishing growth objectives, goals, policies, plans and programs * Act as internal expert on technical advances and industry trends to anticipate and act as a thought leader to management on all matters of major importance, initiate and/or recommend appropriate courses of action and identify those matters requiring policy interpretation or revision * Promote the company to local, regional, national, and international constituencies through networking, speaking engagements, activity in professional associations and publications * Write, review and edit proposals, contract and grant applications/proposals as appropriate * Write and implement standard operating procedures (SOPs) Qualifications: Minimum Required: * Ph.D. in life sciences (preferably Immunology, Cellular Biology) * Minimum 10 years of full-time post-doctoral laboratory experience and demonstrated management experience. Other Required: * Strong bench scientist skills around cell based assays. Hands on flow cytometry experience is required. Preferably with experience in molecular biology. Core competencies of standard biology laboratory experience e.g. cell isolation, multiplexed ELISA is expected. * Experience in validation/qualification of assays to CAP/CLIA/GLP or ISO guidelines. * Ability to lead and organize teams to multi-task and deliver projects according to agreed timelines * Collaborative and an excellent coach and mentor * Familiarity with current regulations regarding the FDA and other Current Good Manufacturing Process Systems (CGMPS); the International Standards of Biological and Environmental Repositories and the College of American Pathologists standards and accreditation requirements; various aspects of the FDAs Modern Quality Systems thinking to include: Quality by Design and Product Development, Quality Risk Management, CAPA (Corrective and Preventive Action) and Change Control * Experience leading or participating in a comprehensive quality systems (QS) model, highlighting the models consistency with the CGMP regulatory requirements for manufacturing products and providing services * Strong written and verbal communication Preferred: * Industrial experience and/or management of outside collaborations

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