KBI Biopharma
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 directing and overseeing 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. Qualifications
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. Compensation
Salary Range: $173,000 - $238,700/yr. In addition to a competitive base salary, KBI provides an annual bonus structure, medical, dental and vision coverage, paid PTO and holidays, 401(k) matching with 100% vesting in 60 days and employee recognition programs. About KBI
KBI Biopharma, Inc. is a global contract development and manufacturing organization providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. Visit
www.kbibiopharma.com . KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. All qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
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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 directing and overseeing 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. Qualifications
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. Compensation
Salary Range: $173,000 - $238,700/yr. In addition to a competitive base salary, KBI provides an annual bonus structure, medical, dental and vision coverage, paid PTO and holidays, 401(k) matching with 100% vesting in 60 days and employee recognition programs. About KBI
KBI Biopharma, Inc. is a global contract development and manufacturing organization providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. Visit
www.kbibiopharma.com . KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. All qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
#J-18808-Ljbffr