Director, Research Project for Quality Control - Baltimore, United States - University of Maryland, Baltimore

Description

University of Maryland, Baltimore (UMB) is seeking to fill the position of Director, Research Projects for the School of Pharmacy Good Manufacturing Practices (GMP) Facility within the Pharmaceutical Sciences Department. The selected candidate will direct the Quality Control (QC) Compliance and testing of clinical supplies with activities funded by the NIH, FDA, and/or private corporations. The Director, Research Projects primarily involves both independent research project(s), working closely with the PI and senior GMP staff, as well as collaborative research studies with members of internal and external to the School of Pharmacy. The selected candidate will interface with the faculty, staff, students, and clients.

Established in 1841, the University of Maryland School of Pharmacy (UMSOP) is the fourth oldest school of pharmacy in the United States. As a leader in pharmacy education, scientific discovery, patient care, and community engagement; the School conducts cutting-edge research and engages in a wide variety of professional practice activities to improve the health and well-being of citizens in the state of Maryland and beyond.

BENEFITS (Exempt Regular):

UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development. This position participates in a retirement program (pension or optional retirement plan/ORP) that must be selected and is effective on your date of hire. Exempt regular staff receive a generous paid leave package that includes over 4 weeks of vacation accrued each year, 15 paid holidays, 3 personal leave, unlimited accrual of sick time, and comprehensive health insurance; professional learning and development programs; tuition remission for employees and their dependents at any University System of Maryland school; and flexible work schedules and teleworking options (if applicable per job).

UMB is Ranked Among the Best Employers for Diversity by Forbes 2022 & 2023.

UMB CORE VALUES:
Respect & Integrity, Well-Being & Sustainability, Equity & Justice, and Innovation & Discovery

COMMITMENT to DIVERSITY
We believe every person brings with them unique strengths, experiences, and perspectives and we value these differences. One of our best opportunities to deliver a workplace that is diverse, inclusive, and focused on equality is to hire candidates who share these values.

The successful candidate for this position will be able to describe and demonstrate their commitment to diversity, equity, and inclusiveness as well as how they contribute to a respectful, positive workplace.

PRIMARY DUTIES:

• Uses subject matter expertise to plan and coordinate the content and delivery of research studies or Good Manufacturing Practices (GMP) projects.
• Provides strategic direction for the research studies or GMP projects, to include establishing goals. Ensure that goals and objectives specified for the research project are accomplished in accordance with priorities, time and funding limitations, or other specifications.
• Evaluate project effectiveness in order to develop and implement new or improved methods. Devise and implement evaluation methodologies.
• Prepares, coordinates, and maintains research study or GMP QC testing content and delivery methods for the daily operations and events within that research study. Plan, develop, administer, and coordinate new or revised project goals, objectives, workflows, and policies through the duration of the research study or GMP project. Implement approved study or trial policies and procedures.
• Organizes and/or participates in various committees and teams to consult with program heads and administrative officials on policy and project needs as well as various administrative issues.
• Assists Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing research studies or clinical trial supplies.
• Ensures compliance with protocols and all relevant local, federal, and state regulatory and institutional policies.
• Manages research project budgets, expenditure adherence, grant applications, and maintenance of inventory on equipment and supplies.
• Coordinates the regular publication of summary reports and serves as an information resource to coworkers, the university, and external figures.
• Develops funding sources for the program, through grant writing.
• Attends research study or GMP related meetings, conferences, and teleconferences, as well as participating in any additional planning and development related activities.
• Develops, validates, and performs High Pressure Liquid Chromatography "HPLC" and "UPLC" assay methods including basic equipment maintenance.
• Performs other analytical methods such as gas chromatography (GC), dissolution testing, and spectroscopy.
• Creates and maintains GMP and GLP compliance documentation.
• Conducts GMP and non-GMP stability studies.
• Maintains careful laboratory records including written lab notebooks and well-organized electronic data files; and for GMP projects, which must be done in accordance with GMP documentation requirements.
• Presents results to PI and contributes to discussions about data and direction of studies.
• Compiles, analyzes, and interprets research data using various relevant computer software applications.
• Prepares manuscripts, reports, reviews, and summaries. Creates GMP documents such as test methods, standard operating procedures, (SOP) and batch records.
• Provides assistance in writing, editing, and feedback for grant proposals and funding applications.
• Presents research findings at national meetings.
• Provides daily operation oversight and orient new students to the team. Develops policies, procedures and/or methods for laboratory experimentation, and for ordering supplies.
• Communicates with lab safety officer to keep students and lab environment safe and compliant with University and GMP regulations. Identifies and addresses issues and deficiencies and implements effective solutions.
• Schedules and coordinates with vendors and tech support for various equipment calibration and instrument maintenance or repair.
• Communicates with clients about project status. Addresses and solves client concerns and problems.
• Troubleshoots problems with experiments, equipment, or other issues that may arise.
• Performs other duties as assigned.

MINIMUM QUALIFICATIONS

EDUCATION: Bachelor's degree in nursing, chemistry, biology, public health, psychology or another scientific discipline appropriate to position required. PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field preferred.

EXPERIENCE: Five (5) years of experience involving program planning and coordination experience in a related field with at least two (2) years in research specialization. Experience in the development and validation of HPLC or UPLC methods strongly preferred.

SUPERVISORY EXPERIENCE: Two (2) years of experience with overall responsibility for program direction, coordination and implementation.

CERTIFICATION/LICENSURE: N/A.

OTHER: No substitution of experience for minimum education requirement.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Thorough knowledge of position requirements.
• Thorough knowledge of all applicable requirements, regulations, and laws.
• Skill in effective use of applicable technology/systems.
• Ability to effectively communicate both verbal and written thoughts, ideas, and facts. Ability to support a mission and strategic vision.
• Instructional, training, and teambuilding skills to strengthen and cultivate relationships. Skill in consultation and change management.
• Ability to demonstrate, understand, apply, and adhere to the UMB Core Values of Respect and Integrity, Well-being and Sustainability, Equity and Justice, and Innovation and Discovery.
• General analytical knowledge of spectroscopy and multivariate data analysis.
• Excellent interpersonal and organizational skills.

Hiring Range: $101,000 – $115,000 per year (Commensurate with education and experience)

UMB is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law or policy. For assistance related to employment, please contact the Staffing department at .

If you anticipate needing a reasonable accommodation for a disability under the Americans With Disabilities Act (ADA), during any part of the employment process, please submit a UMB Job Applicant Accommodation Request . You may also contact . Please note that only inquiries concerning an ADA request for reasonable accommodation will be responded to from this email address.

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