Director, Biologics Laboratory

Description

Who is USP?

The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

Brief Job Overview

The Biologics Laboratory Director role is a hands-on supervisory position responsible for managing both internal and external analytical method development, characterization, and testing to support a comprehensive portfolio of biological standards and platforms. The therapeutic areas and product modalities impacted by this role are extensive and enable manufacturers to develop and release biological medicines. The incumbent will lead and develop staff through mentoring and coaching to cultivate future science leaders. The director will work cross-functionally with other groups within USP Global Biologics as well as other internal and external laboratories to deliver on departmental goals.

How will YOU create impact here at USP?

A comprehensive pipeline of next generation biological standards is critical for the implementation of the Global Biologics strategy. The Director, Biologics Laboratory will be responsible for overseeing proof-of concept, analytical method development, and collaborative testing activities to support development and release of reference materials across multiple therapeutic modalities, including peptides, mAbs/proteins, cell and gene therapy, vaccines, and others. The incumbent will lead an internal team of scientists and will identify and manage external resources that can help advance the biologics strategy.

Provides operational leadership and management of the USP Biologics Laboratory

o Oversees the testing of USP reference materials; supports laboratory team to resolve issues and enhance efficiency.

o Recruits, develops, and mentors laboratory personnel to ensure full staffing and performance.

o Develops staff and succession plans to meet the business needs of the organization.

o Develops and implements laboratory budget, including expenses for personnel, travel, supplies, and capital expenditures.

o Supports implementation, maintenance, and improvement of the lab quality management systems.

o Collaborates with internal staff across USP Divisions to ensure alignment and improve operational efficiency.

Supports Strategic Collaborations and Stakeholder Engagement

o Engages and builds relationships with external stakeholders and laboratories to support development and testing of reference materials.

o Partners with the pipeline development and production team to identify new opportunities and resources.

o Leads efforts to identify collaborators and contract research laboratories; engages with internal legal and quality teams to establish contracts.

o Participates in strategic planning for the department.

o Establishes and monitors priorities consistent with department goals.

o Supports USP to build its external presence through presentations at conferences and publications.

Who USP is Looking For?

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

Ph.D. in biochemistry or related field with at least ten (10) years of experience in analytical testing of biotherapeutics.

Minimum of 5 years of experience supervising, leading teams, and training and mentoring staff members.

Excellent interpersonal skills and written and verbal communication skills.

Ability to work independently and to handle multiple priorities in a fast-paced environment; Strong scientific, computer and organizational skills.

Additional Desired Preferences

Demonstrated success in a people leadership role. Strong business acumen combined with both management and leadership ability.

Effective coach and mentor to staff. Ability to identify and develop talent.

Demonstrated stakeholder collaboration experience, with the ability to quickly develop and manage internal and external relationships and contacts.

Expertise in microbiology and/or viral testing is a plus.

Adept at working in a matrixed organization.

Evidence of learning new areas quickly (has successfully learned and applied learning in new areas multiple times).

Strong experience in the areas of characterization and analysis of biopharmaceuticals.

Knowledge of compendial standards related to biopharmaceutical products/industry.

Strong understanding of the regulatory guidelines applicable to biopharmaceuticals, specifically the chemistry and manufacturing control (CMC) requirements.

Supervisory Responsibilities

The incumbent will have operational management responsibilities for a team of 6-8 laboratory scientists as well. The Director, Biologics Laboratory will also work cross-functionally with other USP laboratories in the US and India and will manage external projects performed by contract labs and collaborators.

Benefits

USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing is protected.

COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired):

As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our workfrom the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)

Job Category Chemistry & Scientific Standards

Job Type Full-Time