SUMMARY OF JOB :

A clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases. Seeking a highly motivated team player and leader to join the company as Director, Clinical and Commercial Supply Chain. This role will be responsible for ensuring that the manufacturing throughout a product’s lifecycle is executed compliantly and within agreed upon budget and timelines

RESPONSIBILITIES:

● Provide management and oversight for timely technology transfer of drug substance and drug product from early to late-stage development and from late-stage development through commercialization throughout the supply chain (i.e., from regulatory starting materials, including labelling, packaging, engraving, through clinical and commercial 3PLs).

● Conceive and execute strategic sourcing plans to ensure clinical and commercial supply distribution demand requirements are met.

● Work with contract organization to establish a serialization program to ensure DSCSA compliance of commercial product.

● Provide CMC support for company’s products including, but not limited to, regulatory submissions and annual product reviews.

● Collaborate with Quality to ensure compliance by contract organizations throughout the supply chain

● Other duties as assigned.

QUALIFICATIONS:

● Bachelor's degree in chemical engineering, chemistry, organic chemistry, or a related scientific discipline; graduate degree strongly preferred.

● Minimum 15 years’ experience in the pharmaceutical industry including small molecules is required; experience with modified release and/or pediatric oral products a plus.

● Strong experience with establishing and managing supply chains for small molecules from development through commercialization.

● Proven track record of working with contract manufacturing organizations from development through commercialization.

● Experience establishing a serialization program appropriate for company size and supply chain complexity is required.

● Strong understanding of GMP and GDP regulations/requirements.

● Ability to communicate clearly and concisely (written/oral) with all levels of the company and with vendors.

● Must be a hands-on team player accustomed to working in a fast-paced environment. #LI- AM2