Director, Sterile & Specialty Product Development

Job Description

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to identify and isolate a molecule that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Our company is seeking a highly motivated candidate for the position of Director, Small Molecule Development within the Mixed Modalities, Sterile Product Development (SPD) team. The successful candidate will be expected to lead the team focused on the design of new formulations and development of robust and scalable processes for parenteral drug products within the small molecule and synthetic modality pipeline.

The Director will report to the Executive Director of Sterile Product Development - Mixed Modalities, and lead a team comprised of 10-15 experienced senior and associate scientists.  The main responsibilities include leading the small molecule parenteral drug product team that designs and executes experiments to support formulation and process development and document technical reports and regulatory filings. The successful candidate will be key in implementing strategy, conducting scientific research from the laboratory to commercial scale, step across boundaries and implement novel innovations into the drug product space to afford world class parenteral development processes for human health while ensuing a phase appropriate approach and adhering to the highest scientific standard. The incumbent will also be responsible for sub-functional strategic planning, coordinating, and execution of SPD initiatives in the company's portfolio from discovery to launch.

The successful candidate must be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. The successful candidate will drive the small molecule parenteral portfolio while collaborating with key stakeholders across the organizations (Research Division / Manufacturing Division) to ensure timebound progression of portfolio, initiatives for scientific & operational excellence, and other strategic initiatives to advance functional impact. The applicant will also have experience in developing intermediate modalities like oligonucleotides and peptides and have an external network both across industry and academia. Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in development.

The incumbent will also be responsible for the recruiting, appraisal, and development of personnel under her/his supervision. The Director selects, trains, and effectively recommends transfers, merit increases, promotions, and closures of personnel under her/his direction within the framework of Company policy. The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also have a proven track record of developing talent from a diverse scientific background and will have the ability to advance our company's commitment to a diverse and inclusive work environment.

Essential Knowledge, Duties & Responsibilities for the Director Include:

• Sterile drug product development concepts, tools, and requirements for all dosage forms (liquid, lyo, drug-device combinations)
• Review and approval of data and technical documents
• Ability to recruit, select, develop, and mentor talent
• Strategic and critical thinking to advance sterile product development strategy
• Project management skills
• Attention to technical detail
• Builds collaborations across internal departments and key stakeholders
• Ability to lead and champion organizational structure and be a change agent when necessary
• Developing the departmental budget and meeting the agreed upon spend
• Collaborates and builds strong relationships with upper management and other disciplines to select and qualify new CMOs/CROs/CDMOs

Qualifications:

Education:

• Ph.D. in chemical engineering, chemistry, pharmaceutical sciences, pharmaceutics, biochemical / biomedical engineering, or relevant field with minimum of 8+ years of industrial experience
• B.S. or M.S. in chemical engineering, chemistry, pharmaceutical sciences, pharmaceuti