Associate Director, CMC Formulation

Job Summary: :
The Associate Director, CMC Formulation will design, execute, and lead pre-clinical and clinical formulation development efforts and associated manufacturing in the development of solid/liquid oral dosage forms for use in clinical studies and potential commercialization. He/she will serve as a technical expert in the area(s) of expertise throughout the organization and will coordinate/author/review drug product relevant sections of regulatory documents. In addition, the successful candidate will oversee the selection, tech transfer and execution of drug product development and manufacturing plans at external partners. The candidate must have extensive knowledge and hands on experience on equipment’s and processes commonly used for solid and liquid oral formulation development.

Primary Responsibilities: :

• Serve as the scientific leader in drug product formulation, develop strategic development plans in alignment with our clinical trial plans and company goals. Design phase appropriate formulations at different stage of development (preclinical to clinical phase III) and commercialization.

• Designs and executes pre-clinical and clinical formulation development experiments to develop and support solid and liquid oral dosage form products. Technical expertise in solid/liquid oral dosage form development and scale-up.Design and execute physicochemical characterizations of new chemical entity (NCE) as needed.

• Work in close collaboration with the Project and CMC teams and related functions, including discovery, non-clinical development, process development, analytical development, Quality, clinical supply chain, and Regulatory.

• Site selection of CDMO’s for drug product development and manufacturing. Manages formulation development and clinical manufacturing activities at external laboratories and manufacturing facilities.

• Actively communicates, collaborates with and contributes to other functional areas and CDMO to solve problems and achieve goals. Oversee tech transfer and future validation of drug product manufacturing processes.

• Authors and reviews formulation related sections for regulatory filings, development reports and other development related documents.

• Some travel (10-20%) required of this position.

Qualifications: :

• Advanced degree in pharmaceutical science, chemical engineering or related scientific field with a minimum of 10 years post-doctoral.

• The successful candidate has a strong understanding of drug product and CMC development in the biopharma industry.

• A proven track record in developing and scaling up oral dosage form from clinical development and commercial product.

• Experience and expertise in formulation development of poorly soluble (BCS Class II/IV) compounds (small molecules).

• Extensive knowledge and hands on experience with equipment’s and processes commonly used for solid and liquid oral dosage forms.

• Know-how to support preclinical studies with variety of formulation approaches and delivery routes.

• Working knowledge of methods and instrumentation used for the characterization of solution and solid state properties of materials.

• Background in applying statistical approaches in the design and analysis of experiments and experience with Quality by Design (QbD) is preferred.

• Responsible for managing form selection/characterization, pre-formulation, formulation development, delivery of clinical supplies, development of efficient and scalable manufacturing processes.

• Excellent verbal and written communication skills, ability to effectively work across levels, functions and companies.

• Author and review drug product sections in the CMC sections of regulatory submissions, internal and vendor reports.

General Qualifications: :

• Collaboration & Teamwork: : Relates to employees and management in a cooperative manner that helps others to achieve their best.

• Productivity/Organizing/Planning: : Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.

• Communication Skills: : The ability to convey both written and verbal information effectively and efficiently.

• Willingness to Acknowledge Areas for Growth: : Understands need for growth and is receptive to constructive feedback.

• Detail-Oriented: : Follows precise procedures and demonstrates thoroughness in performing job tasks and assignments.

How to Apply: Please complete the application below and include the following attachments:

• Cover Letter

• CV / Resume

• Research Summary (if applicable)

About Enanta: Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta’s research and development programs include clinical candidates currently in development for the following disease targets: respiratory syncytial virus (RSV), SARS-CoV-2 (COVID-19) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV).
Enanta’s research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

E_n_anta Pharmaceuticals is an equal opportunity employer (EOE) with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, religious creed, gender, gender identity, sexual orientation, physical or mental disability, protected veteran status, or any other class protected by law.

Job Type: Full-time