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Job

Director, Pharmaceutical Development

  • Location

    REMOTE

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Antoinette Miller

  • Contact email:

    a.miller@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Job ref:

    #LI- AM2

  • Published:

    22 days ago

  • Expiry date:

    2021-11-15

  • Startdate:

    ASAP

This company is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. 

POSITION SUMMARY:

The Associate Director or Director of Pharmaceutical Development will be a liaison for the manufacture of Companys' small molecule development drug products (DPs) at external contract development and manufacturing organizations (CDMOs). This individual will work in a cross functional team environment with colleagues from process development, analytical, formulation development, supply chain, QA, and regulatory CMC to plan, coordinate, and execute internal and external DP development and manufacturing activities.

ESSENTIAL DUTIES & RESPONSIBILITIES:

  • Provide scientific, technical, and strategic direction to the design, development, and manufacture of investigational drug products from pre-clinical/clinical to commercial stage.
  • Manage activities and contractual relationship with contract manufacturers and laboratories performing product/formulation development, manufacturing, analytical development and testing, stability, and validation services.
  • Lead and collaborate with cross functional project team members to meet CMC goals.
  • Represent CMC DP and provide strategic recommendations and status reporting to cross-functional program team.
  • Author, review, and/or approve development reports, regulatory submissions (e.g., IND, IMPD, NDA, MAA), and SOPs.
  • Build internal and external capabilities to support rapid progression of programs and ensure data generation per regulatory requirements.
  • Act as Subject Matter Expert for knowledge of GMP regulations, ICH guidance, and current regulatory expectations regarding DP manufacture and process control.
  • Manage CMC DP program budget within the framework of an internal and outsourced development and manufacturing business model.
  • Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.

REQUIRED EDUCATION AND EXPERIENCE:

  • MS/PhD degree or equivalent in Pharmaceutics, Chemistry, or related field.
  • 8 to 10+ years of progressive experience in the Biotech or Pharmaceutical industry focused on small molecule drug product development and manufacturing (experience in a late phase manufacturing environment is preferred).
  • Extensive experience in the formulation of solid oral dosage form pharmaceutical products.
  • Experience working with contract manufacturing organizations including a working knowledge of small molecule drug product validation.
  • A strong track record of scientific achievement and a willingness to spend 5-10% of time in the lab.
  • Familiarity with ICH guidelines and regulatory expectations relevant to drug development and cGMPs including regulations in multiple countries.
  • Established and demonstrated project management skills (knowledge of MS Project a plus).
  • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment 
  • Effective interpersonal and communication skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems.
  • Strong learning orientation, curiosity, and passion for science and patients.

They an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation. 

#LI- AM2