• Pre-Clinical & Clinical Supplies Manager

    Job Locations US-PA-Wayne
    Posted Date 3 months ago(10/18/2018 1:45 PM)
    Job ID
    2018-1218
    # of Openings
    1
    Category
    Research & Development
  • Overview

    We are Aclaris Therapeutics – committed to meeting the needs of patients with skin and hair conditions with innovative treatments that define new standards of care in dermatology and immunology. 

     

    Reporting to the Senior Director, Product Development & Manufacturing, the Pre-Clinical & Clinical Supplies Manager is responsible for supporting the manufacture, forecasting, inventory management, labeling, packaging, and logistics of non-clinical and clinical supply requirements. This position works closely with R&D, manufacturing, quality assurance, pre-Clinical, Clinical, and contract manufacturing and packaging organizations, as required, to implement the preclinical and clinical strategies for drug development programs and products

    Responsibilities

    • Translate the non-clinical and clinical supply requirements into an executable manufacturing, packaging and labeling plan to ensure all toxicology and clinical drug supplies are available as needed to maintain project timelines.
    • Collaborate with Clinical Development and Operations, Product Development, Regulatory Affairs, Quality Assurance, and Project Management to determine appropriate quantities, packaging configuration, labeling, blinding techniques, and optimal shipping plans.
    • Manage and plan forecasts to supply/re-supply all non-clinical and clinical studies to support project timelines.
    • Maintain CMC documentation in support of non-clinical and clinical trials, including but not limited to batch records, packaging records, COAs, stability tables, shipping temperature data.
    • Develop and obtain required approvals for global clinical labeling activities.
    • Serve as the point of contact with clinical secondary packaging and labeling vendors to coordinate labeling, packaging, and shipment of packed supplies and ensure all work is completed accurately and on time.
    • Resolve logistical conflicts impacting non-clinical and clinical studies and development milestones.
    • Proactively identify and communicate study timeline or clinical supply risks, from a supply chain perspective, to all key stakeholders on the project.

     

    Additional Responsibilities:

    • Provide project specific support to resolve issues, as required
    • Review existing applicable SOPs and identify the need for and assist with SOP development, as required.

    Other Duties:

    Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

     

    Qualifications

    Required Education and Experience:

    • B.S. or B.A. with a minimum of 5 years’ experience in pharmaceutical development with clinical supplies responsibilities.
    • Excellent written and verbal communication skills to collaborate well internally and externally.

    Preferred Education and Experience:

    • Experience with clinical supply logistics required, and non-clinical a plus.

     

    Required Knowledge, Skills, Abilities & Behaviors:

    • Knowledge of global clinical labeling requirements, cGMPs, cGCPs, FDA regulations and clinical research
    • Demonstrated ability to work both independently and as part of a multidisciplinary team to contribute to the successful development of pharmaceutical drug products on time.
    • Detail oriented with good organizational skills.
    • Demonstrate honesty and integrity while modeling behaviors consistent with company standards and policies for business and compliance related matters
    • Ability to thrive in a highly driven culture that is performance based, fast paced, and results oriented
    • Proficiency on excel, word, power point and other software skills

     

     

    Work Conditions:

    This job operated in a professional office environment. This role routinely uses standard office equipment such as computers, phones and photocopiers.

     

    What We Provide:

    At Aclaris Therapeutics, we are proud to offer if eligible, a highly competitive compensation plan with an excellent benefits package including the following: 

    • Company Sponsored Insurance: Medical, Dental, Vision, Life Insurance, AD&D Insurance Short-Term Disability and Long-Term Disability
    • 3 Weeks Paid Vacation
    • 14 Paid Holidays
    • 401(k) with a generous match!
    • On-site Gym with personal trainer, free for employees!
    • Fun environment!
    • Free Snacks Daily!
    • Pizza Friday – free for employees!
    • Catered lunches and other fun events!
    • Hands-on management to provide comprehensive training and professional development
    • Advancement opportunities
    • Modern office in beautiful corporate park with access to parks, shopping and restaurants

    Location:

    640 Lee Road

    Wayne PA 19087

     

    Hours:

    Standard hours

    9:00AM-5:00PM, Monday-Friday

     

    Aclaris Therapeutics, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity.

     

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