The Associate Director, Validation is accountable for validation activities at the KBI Boulder facility for the following disciplines:

• Facilities qualification

• Utilities qualification

• Equipment qualification

• GAMP 3-5 automation qualification including Part 11

• Cleaning validation including changeover equipment strategies

• Steaming validation

• Air visualization validation

• Product independent liquid to liquid mixing

• Controlled temperature units/areas

• Validation maintenance

• TOC recovery studies

Staff will provide technical decision-making regarding validation strategies as well as requirements for projects and change controls. This position will ensure that validation programs are effectively implemented to produce biopharmaceuticals in a multi-product facility. This includes drafting and owning risk assessments, plans, and procedures. Staff will be responsible for reviewing and approving team member's work.

Staff will actively manage a team of full time employees and contractors. This includes the following:

* Ensuring adequate onboarding, support administration, and training for staff

* Providing managerial support for staff working in cross functional teams

* Providing technical guidance to ensure work is completed in a compliant and efficient manner

* Ensuring adequate resource management to ensure projects are adequately staffed with trained team members and that staff can maintain work life balance

* Facilitating staff development

Staff member will be expected to provide exceptional customer service to internal and external clients. Staff must have the ability to interface effectively with personnel across quality, engineering and other technical disciplines. Staff are responsible for the inspection ready state of the Validation Group and will be the primary presenter in inspections and client audits. Knowledge of Quality Systems and cGMP requirements for multiple regulatory jurisdictions (FDA, EU, ICH) and the ability to effectively evaluate and escalate risk is required.

Minimum Requirements

• Minimum of Bachelor's degree in a scientific, engineering, or biochemical engineering discipline and 10+ experience in validation in the pharmaceutical/biotechnology field equivalent required and 5+ years management experience.

Demonstrated track record in the following key areas:

• Strong orientation for quality and customer service

• High level of integrity and personal responsibility

• Communication skills within all levels of an organization

• Understanding guidance and predicate rules associated with subject matter expertise

• Risk assessment and risk management

• Project management including project delivery under aggressive timelines

• Staff development and coaching

Salary Range: $130,000 - 165,000

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, FTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, 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.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.