• Senior Director, Chemical Development

    Job Locations US-MO-St. Louis
    Posted Date 5 months ago(2/18/2019 8:30 AM)
    Job ID
    2019-1286
    # of Openings
    1
    Category
    CDT - R&D
  • 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 SVP of Pharmaceutical Research and Development, the Sr. Director of Chemical Development will be responsible for the design and implementation of phase appropriate API supply strategies to support the Aclaris Early Development Portfolio.

    The selected candidate will lead the transition of synthetic routes from Discover Chemistry Teams to deliver scalable processes to support initial GMP manufacture of API for Phase I/II clinical trials and support the technical transfer of processes as the projects transition towards validation, product registration, and commercialization.

    The ideal candidate will ensure that all development and manufacturing activities are conducted in a manner consistent with regulatory requirements while integrating quality by design and quality risk management principles into the development of the API process.

     

    Through the development of synthetic novel routes, and/or improving existing routes, the CMC lead will also develop stage appropriate analytical methods, and oversee contractor relations, chemical and analytical development, and the manufacture and supply of API’s for production of clinical trial materials (CTM).

    Responsibilities

    • Provide technical oversight, problem solving, resource allocation on Supply Chain and CMC development activities including process development and transfer, Quality by Design (QbD) manufacturing, and translate results into deliverable milestones.
    • Contribute to the identification, selection and management of Contract Manufacturing Organizations (CMOs) for process optimization, cGMP manufacture and supply of Active Pharmaceutical Ingredient (API) in support of ongoing clinical programs.
    • Develop and implement strategies for optimizing and controlling quality of bulk API using internal and external QA support.
    • Oversee and manage contract manufacturing organizations (CMOs) to prepare batch records, product development reports and other development-related documents. Be on-site, as necessary.
    • Deliver scalable and cost-effective API manufacturing routes and materials for preclinical and clinical programs that fund the manufacture of clinical trial materials
    • Working with integrated cross-functional program teams develop budgets and project updates to achieve pre-clinical and clinical development goals and timelines.
    • Responsible for all drug substance activities from preclinical development through manufacture of clinical supplies to support Phase I and Phase II Proof of Concept and support the transition to Chemical Manufacturing for process validation and production of registration batches.
    • Support the development and manufacture of stable and GMP radiochemical isotopes for bioanalytical method development and preclinical 14C-ADME and clinical hAME studies, respectively.
    • Direct efforts to implement stage appropriate analytical methods and protocols and ensure that all CROs and CMOs are using systems and processes in compliance with all relevant regulatory standards.
    • Author and review of CMC sections for regulatory filings.
    • Travel requirements (< 20%)

    Qualifications

    • An advanced degree, PhD or MS with 10+ years of experience, in Pharmaceutical Chemistry, Organic Chemistry, Process Chemistry, Chemical Engineering or related scientific discipline
    • A successful history of accomplishment in the GMP manufacturing of New Chemical Entities (NCE’s)
    • A minimum of 5 years of supervisory experience, including the management of external resources, and a proven ability to work collaboratively and effectively on a multi-disciplinary team
    • Solid understanding of all facets and phases of CMC drug development
    • Expertise in synthetic organic chemistry and process optimization
    • Expertise in API development and GMP regulations required for the manufacturing of finished product for human clinical studies
    • Solid understanding and experience with polymorph and salt screening technologies
    • Experience with IP protection of compositions, processes and solid form patents
    • Knowledge of CMC requirements for regulatory filings covering all phases of pre-clinical and clinical development in both the US and ex-US markets
    • Demonstrated ability to negotiate and manage CRO and CMO contracts and activities
    • Proven track record of advancing compounds from pre-clinical candidate nomination through toxicology studies, IND filing and human clinical studies
    • Demonstrated technical and project management capabilities
    • Knowledge of manufacturing processes and methods for cost-control, quality improvements, yield improvements and manufacturing efficiency
    • Adept at creating and communicating a clear vision among direct reports and vendor relationships, effectively developing strategy, aligning resources, and overseeing implementation to achieve program goals
    • Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills
    • Demonstrated success managing multiple projects with timely and accurate output
    • Substantial experience managing US and International CRO/CMOs for the manufacture of GMP APIs
    • Substantial experience with projects in clinical development e.g. Phase 1 through Phase 3
    • Experienced with cGMP manufacturing and IND, CTA and NDA filings; thorough knowledge of relevant FDA and EMEA regulations

    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!
    • Fun environment!
    • Free Snacks Daily!
    • Hands-on management to provide comprehensive training and professional development
    • Advancement opportunities

    Location:

    St. Louis, MO or Wayne, PA

     

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

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