Associate Director, Oral Drug Product Development (ODPD)

Education & Experience Requirements

• Bachelor’s degree in Pharmaceutical Sciences,  Chemical Engineering, or closely related field with 15+ years of Pharmaceutical Industry experience is required.

• M.S. Degree in Pharmaceutical Sciences, Chemical Engineering, or closely related field with 13+ years of Pharmaceutical Industry experience is required.

• Ph.D. Degree in Pharmaceutical Sciences, Chemical Engineering, or closely related field with 10+ years of Pharmaceutical Industry experience is required

• Supervisory experience is required

• Significant experience in oral drug product formulation development, process development and manufacturing is required.

Key Skills and Competencies

• Proven working knowledge of current GMP regulations.

• Detailed knowledge of Global regulatory requirements for drug products.

• Knowledge of current pharmaceutics technology, including formulation and manufacture of oral solid, liquid and semi-solid dosage forms. Sterile product experience is desirable

• Experience in robust process development, scale-up, manufacturing and validation, including DOE and QbD.

• Knowledge of clinical supply requirements and regulations.

• Must have a working knowledge of various analytical methods used during the development of pharmaceutical products, including, but not limited to, HPLC, IR, UV, NMR, Mass Spec., dissolution and tablet hardness, etc.

• Must be able to apply product development expertise to CMC sections of the regulatory filings.

• Experience of both Early and Late-stage development including product stability and product packaging and labeling requirements.

• Ability to present complex issues well in oral and written form.

• Ability to work independently, take initiative, and complete tasks to deadlines.

• Excellent interpersonal, communication, analytical, managerial, and organizational skills.

• Ability to effectively present information to senior management, external CDMOs and employees at all levels of the organization.

• Excellent management skills for coaching and mentoring team members and reporting staff (employees and/or contractors).

• Strong team player.  Excellent leadership skills. Basic knowledge of project leadership tools including MS Project

Complexity and Problem Solving:

• Objective setting of any reporting staff (employees and/or contractors).

• Budget management and sign off at Assoc.Director authorization level, CMC -DP strategy development, implementation, and vendor selection

• Author, review, approve and manage product development protocols and reports

• Authoring, review, approval and management of high-quality global CMC regulatory submissions and timely responses to agency RTQs

• Accountable to the Director or Sr. Director, ODPD-US

• Internal contacts: PSPL, AD, SMPD, Pharm Sci QA, CPA, CMC-GRA, GMSGQ

• External contacts: Regulatory agencies. Vendors: DP Development and contract manufacturing organizations

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.