Associate Director, Chemical Development and Manufacturing

Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes.

Job Summary:

The Associate Director of Chemical Development and Manufacturing is responsible for the technical development of small molecule drug substances from IND-enabling studies to commercialization. Incumbents will lead the drug substance process development and Current Good Manufacturing Processes (cGMP for external contract manufacturing and development organizations (CDMO). Responsible for the preparation and review of technical development reports and authoring of the CMC sections of regulatory submissions including IND, IMPD, NDA, and MAA.

Essential Duties & Responsibilities:

• Provides technical, functional, and project leadership on drug substance development, manufacturing, and CDMO management.
• Leads and directs drug substance development and manufacturing activities at CDMO partners, including process R&D, GMP manufacturing and technology transfer, while meeting aggressive program timelines/budgets and long-term company goals.
• Contributes to the strategy, planning, execution, and progress reporting of development projects.
• Supports the identification, evaluation, and selection of contract service partners.
• Works collaboratively with other internal functions including analytical, formulation development, non-clinical development, regulatory, and quality.
• Author and review process development reports, technical documents, batch records, and sections of regulatory filings related to drug substance (IND, IMPD, DNA and MAA).
• Other responsibilities and projects assigned.

Supervisory Responsibilities:

• N/A.

Knowledge & Other Qualifications:

• A minimum of six years of relevant experience with a PhD or nine years of relevant experience with a Masters degree in Organic chemistry or biological science.
• Experience in small molecule drug substance process development in biotechnology or pharmaceutical industry is preferred.
• Extensive knowledge and experience in synthetic route development, process optimization, and drug substance large-scale manufacturing from early to late stage up to validation campaigns.
• Familiarity with QbD principles and risk-based process development.
• In-depth knowledge of solid-state properties of small molecules.
• A broad understanding of cGMP requirements, ICH, FDA, and EMA guidelines with respect to pharmaceutical product development and manufacturing.
• First-hand experience in authoring drug substance sections of regulatory submissions including NDA, MAA, IND, and IMPD.
• Prior experience in selecting and working with domestic and international CDMOs.
• Strong problem-solving and decision-making skills.
• Excellent communication skills and collaboration abilities.
• Ability to travel occasionally to the CDMO locations as needed.

Other Characteristics:

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• Ability of having an innovative and dynamic approach to work.
• A self-starter able to work independently but comfortable working in a team environment.
• Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others.
• Capable of performing other duties as assigned by Management.
• Authorized to legally work in the United States without visa sponsorship.

Physical Requirements/Work Environment/Travel Requirements:

• Sedentary work, when not working in the lab. Exerting up to 10 pounds of force occasionally and/or carry objects. Sedentary work involves sitting most of the time.
• When in the lab, employees will be required to exert up to approximately 50 pounds of force occasionally and/or up to 30 pounds of force frequently, as well as exert up to 10 pounds of force constantly to move objects, when working in the lab.
• The employee is required to have close visual acuity to perform an activity such as; preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading. The worker is also required to have the visual acuity to perform activities such as operating machines, and to perform mechanical or skilled trade tasks of a non-repetitive nature.
• Will be required to work in a clean processing room environment occasionally and wear personal protective equipment to include but not limited to: gloves, safety glasses or goggles, face shields, lab coats, ear plugs, half mask air purifying respirator, or powered air purifying respirator (PAPR) and Tyvek suits occasionally.
• The employee is not substantially exposed to adverse environmental conditions on a regular basis. Employee may have to wear Tyvek suits when working in the lab, which can make conditions, warmer, and more challenging. Employee will be required to work and exert force while wearing Tyvek suits.
• Position may require prolonged sitting, prolonged standing, balancing, stooping, bending, kneeling, crouching, walking and pushing.

Compensation:

At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $155,000 to $185,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs.

You also will be able to participate in a competitive benefits package, including but not limited to: health, dental, vision, paid time off, 401k company match, company paid life insurance and health and wellness benefits. The total compensation package for this position also includes other compensation elements such as stock equity awards, employee stock purchase programs and participation in our Company's discretionary annual bonus program.

Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.