Director, Microbiology

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. 

Position Summary:

This individual will direct microbiology activities at Patriot Park. Responsible for the development, maintenance and harmonization of microbiology procedures and systems related to Quality Control oversight. Provides strategic and technical expertise in all cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the KBI internal requirements.

Responsible for the directing and overseeing of microbiology monitoring and product testing at Patriot Park.

Responsibilities:

·       Develop strategy and drive harmonization of microbiology programs.

·       Provide strategic and technical expertise to Patriot Park and Hamlin Rd. KBI sites to ensure microbiology procedures, and decisions meet regulatory and KBI requirements and are based on documented scientific rationales.

·       Lead, assess, coach and develop departmental associates. Manage performance; ensure team meets company, site and personal expectations and meets objectives;

·       guide the professional growth of team.

·       Ensure all personnel at both facilities are trained to appropriately perform expected duties.

·       Encourage a quality culture of inclusion and high standards to ensure a high performing team.

·       Expert understanding of regulations and industry expectations. Support regulatory and client audits.

Requirements: 

• BS and 12+ years’ experience or MS and 10+ years’ experience in a QA or GMP environment or equivalent.

• Experience leading and managing microbiology laboratories in an FDA regulated manufacturing environment.

• Demonstrated expert knowledge of relevant FDA and EU regulations as well as hands on experience in a low bioburden and aseptic processing setting.

Language Ability

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedures. Ability to effectively present information and respond to questions from staff, colleagues, managers and clients. Ability to read, analyze and author complex documentation.

Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Math Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Computer Skills

Word processing, Database, Spreadsheets, Power Point, Internet, E-mail, Calendar Management, quality management electronic systems

Salary Range: $173,000 - $238,700/yr.

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs.   

About KBI: 

KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life scie