Drug Product Development, Assistant Director

Supernus Pharmaceuticals, Inc.
Rockville, MD
Sep 22, 2021
Sep 24, 2021
Full Time
Job Summary:A' Assists with directing the development and operations of the Drug Delivery Sciences drug product development group.Essential Duties & Responsibilities:Provides technical expertise and supervision to the drug product development group in the areas of preformulating evaluations, formulation development and process developmentProvides supervision to the drug product development group in the manufacture and packaging of cGMP clinical supplies, on-site and/or at contract manufacturing organizations, in support of the Company"s clinical development programProvides technical expertise and supervision to the drug product development group in drug product technology transfer and scale up, registration, prevalidation and validation activities at contract manufacturing organizationsCollaborates with the Commercial teams in defining drug product trade dress and commercial packagingSupports the drug product regulatory process by writing and reviewing sections of CTDs for INDs, CTAs and NDA submissions, amendments and yearly updates.A' Contributes to briefing packages and represents the product development group as needed at CMC related FDA meetings.Supports the Corporate Development department evaluating drug product opportunitiesSupports the Company"s intellectual property activitiesReviews and approves specifications, master batch records, SOPs, product development protocols and technical reportsContributes to the yearly departmental operating budget, head count and equipment needs based on the approved project objectives.A' Assists with the contract bid quotation and award process for departmental projects at third party organizationsParticipates as a project team member or leader as neededRegularly communicates progress of projects to the group and/or department head and as required senior managementResponsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.Ensures the drug product development group complies with current SOPs, Safety and Environmental Regulations and cGMPsA$ A' "A' ?Supervisory Responsibilities:Provides leadership and management over personnel in Drug Delivery Sciences drug product development group in an effective manner to accomplish corporate objectives.A' A' Knowledge & Other Qualifications:Ph.D. in a Pharmaceutical or Physical Science or equivalent combination of education and experience4+ (w/ Ph.D.), 6+ (w/ MS), or 8+ (w/ BS) years of relevant experience in pharmaceutical and/or cGMP3+ years of supervisory experienceMust be an innovative thinkerMust have proven track record in the drug development process, manufacture of clinical supplies and drug product technology transfer and scale up.Must have experience in traditional preformulation sciences.A' Experience in biopharmaceutical in silico modeling is a plus.Must have proven track record in cGMP regulations and quality systemsAbility to read, analyze and interpret scientific and technical and regulatory documents.A' Ability to respond to complex inquiries or complaints from customers or regulatory agencies.A' Ability to effectively present information to top management and groups.Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.A' Ability to deal with a variety of abstract and concrete variables.Demonstrated technical, interpersonal, communication and leadership skills and the ability to work on cross functional teams.A' Other Characteristics:Ability to work independently and as part of a team.Ability to maintain high ethical standards of integrity and quality.Capable of being innovative and dynamic in approach to work.A' Capable of performing other duties as assigned by management.Authorized to legally work in the United States without visa sponsorship.A' Physical Requirements / Work EnvironmentSedentary work, when not working in the lab. Exerting up to 10 pounds of force occasionally and/or carry objects. Sedentary work involves sitting most of the time.When in the lab, employee will be required to exert up to approximately 50 pounds of force occasionally and/or up to 30 pounds of force frequently, as well as exert up to 10 pounds of force constantly to move objects, when working in the lab.A' The employee is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; and extensive reading. The worker is also required to have the visual acuity to perform activities such as operating machines, and to perform mechanical or skilled trade tasks of a non-repetitive nature.A' Will be required to work in a clean and/or sterile laboratory environment occasionally, and wear personal protective equipment to include but not limited to: gloves, safety glasses or goggles, face shields, lab coats, aprons, ear plugs, dusk masks and Tyvek suits occasionally.A' The employee is not substantially exposed to adverse environmental conditions on a regular basis. Employee may have to wear Tyvek suits when working in the lab, which can make conditions, warmer, and more challenging. Employee will be required to work and exert force while wearing Tyvek suits.Position may require prolonged sitting, prolonged standing, balancing, stooping, bending, kneeling, crouching, walking and pushing.A' A' Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.