Senior Director, Api Process Development And Manufacture

Our team is driven by the desire to make a positive difference in the lives of patients. We are passionate about innovative science and strive to discover and develop novel medicines, to bring value to the healthcare ecosystem, and to address significant unmet medical needs. We foster a culture of innovation, collaboration, transparency, mutual respect, and integrity and an environment where employees feel fulfilled by the work they do and are recognized for the contributions they make.

Escient Pharmaceuticals is a San Diego based a clinical-stage company focused on developing novel therapeutics to address a broad range of neurosensory-inflammatory disorders. The company’s pipeline includes two first-in-class small molecule antagonists targeting MRGPRX2 for the treatment of various mast cell mediated disorders and MRGPRX4 for cholestatic pruritus. Escient is led by an experienced management and scientific team and funded by top-tier life science investors.

The Senior Director, Process Development and Manufacture will oversee key scientific, regulatory, and business functions pertaining to process chemistry at the company, including development of chemical processes and analytical methods for active pharmaceutical ingredients (APIs), process scale-up, technology transfer, validation of chemical processes and analytical methods, analytical quality control and support of regulatory submissions by provision of required scientific data and document review. Effective management of CROs and CMOs will be a key strategy and activity required to accomplish the functions mentioned.

RESPONSIBILITIES:

• Manage multiple CMOs/CROs to deliver final substances and intermediates that are of sufficient quality and quantity to meet corporate objectives and regulatory requirements.
• Manage multiple process chemistry projects simultaneously, at different stages of drug development.
• Create and disseminate technical transfer information and documents required by CROs/CMOs to develop and scale up chemical processes and develop analytical methods for APIs.
• Establish and maintain business relationships with CROs and CMOs appropriate for performing the process and analytical development requirements for Company API candidates.
• Compose key terms for and execute contracts; manage the activities of CROs/CMOs required to deliver process/analytical development tasks on time and within established budgets.
• Maintain in-depth knowledge of chemical steps, manufacturing processes and quality control.
• Ensure that CRO/CMO activities and other Process Development activities address drug substance needs for pharmaceutical formulation development, toxicology testing, clinical trials and commercial launch.
• Ensure that all chemical processes are developed to deliver Company targets of cost, quality, safety, environmental and operability needs.
• Maintain a working knowledge of manufacturers and suppliers of chemical raw materials, reagents, and intermediates capable of addressing the process requirements of Company in a timely and economical manner.
• Identify and lead key process problem resolution activities and process improvement initiatives.
• Lead scale-up, Process Development, process engineering, and finalization (locking) of process for eventual commercial-scale manufacturing.
• Extract scientific data and provide appropriate document review to support regulatory filings and commercialization in a timely manner.
• Lead and develop a Process Development team as appropriate.
• Create a culture of continuous improvement and high-performance teamwork.
• Continually seek and implement Process Development best practice methodologies.
• Work closely with Company QA unit to a) develop and operate to appropriate CMC procedures and b) ensure product meets established quality standards.

QUALIFICATIONS:

• Minimum of MS in Organic Chemistry or related scientific field. PhD preferred.
• Minimum of 12 years in chemistry, manufacturing, and controls of active pharmaceutical ingredients (API).
• Demonstrated experience in managing API chemical development, process validation and manufacturing in support of NDA marketing applications and commercial production.
• Demonstrated track record of delivering candidate(s) into chemical manufacturing and commercialization.
• Demonstrated chemistry development at industrial scale; prefer experience with peptide chemistry.
• Significant project leadership experience.
• Strong aptitude and demonstrated experience in synthetic organic chemistry.
• Working knowledge of modern analytical separations techniques pertaining to the separation/purification of organic compounds.
• Working knowledge of analytical methods Development and validation.
• Familiarity with FDA and ICH guidelines for INDs/NDAs/MAAs and cGMPs.
• Experience in managing CMOs, scientific collaborations and contracted R&D.
• Ability to effectively manage highly skilled internal staff (direct reports).
• Training and education in organic synthesis.
• Working knowledge of process economics.
• Ability to work independently as well as in a team; ability to build good work relationships.
• Strong attention to detail and time management skills.
• Excellent oral and written communication skills.

SALARY RANGE: $225,000-$255,000

If you thrive in a fast-paced, entrepreneurial environment and are in search of a dynamic, multi-disciplinary team focused on discovering and developing therapies that will positively change the course of the health and well-being of underserved patients, we encourage you to apply. Escient Pharmaceuticals offers a positive and exciting work environment with competitive pay structures and benefits. Escient is an equal opportunity employer.