PharmaDX Scientific Manager

Job Details

Description

Schedule:
Monday - Friday (40 hrs/wk)
8:00 AM - 5:00 PM

Department: PharmaDx - 511

Primary Purpose:

The PharmaDx Scientific Manager is a member of the PharmaDx management team who oversees and guides the technical and laboratory aspects of companion diagnostic assay development and manufacturing under design control. The PharmaDx Scientific Manager also oversees the manufacturing of components for companion diagnostic assays under Good Manufacturing Practice (GMP) guidelines and participates in preparing data and documents for FDA submission. The PharmaDx Scientific Manager ensures that companion diagnostic development and component manufacturing milestones and deliverables are met as outlined in contracts with PharmaDx partners. Manages direct reports and provides leadership for the PharmaDx technical team which may include scientists, project managers, and technicians. This position reports to the PharmaDx Director and works with limited supervision with wide latitude for independent judgment and decision making. Strong project management skills are required to provide oversight for multiple complex projects occurring simultaneously.

About ARUP:

ARUP Laboratories is a national clinical and anatomic pathology reference laboratory and an enterprise of the University of Utah and its Department of Pathology. Based in Salt Lake City, Utah.

ARUP proudly hires top talent to create a work environment of diversity, professional growth and continuous development. Our workforce is committed to the important service we provide to over one million patients each month. We always strive for excellence and have a strong desire to have involvement with the advances in medicine and the role laboratory services plays within each patient’s life. We never forget that there is a patient behind every specimen we receive.

We are looking for individuals who want to contribute to ARUP's culture of accountability, integrity, service, and excellence. Consider joining our dynamic team.

Essential Functions:

Personnel Management Functions:
Trains, supervises, and provides leadership for direct reports in the PharmaDx technical team, which may include scientists, project managers, technicians, and other technical staff.

Ensures new and existing staff are properly trained in all technical and safety procedures.

Responsible for performance reviews and providing professional development opportunities for direct reports.

Collaborates with the PharmaDx Directors and Human Resources to post new positions, interview, and hire new team members and performs disciplinary actions as needed.

Oversees projects and their assigned resources in order to meet requirements, timelines and deliverables and to maintain compliance with applicable standards, regulations and policies.

Manage schedule logistics for project dependent timelines and manufactured product planning.

Leads regular laboratory meetings.

Motivates employees to maintain a positive professional, productive, and safe work environment.

Allocates time and resources among project team members needed to carry out activities.

Reviews deliverables and reports produced by project team members prior to sharing with stakeholders.

Oversees the manufacturing of components for companion diagnostic assays under Good Manufacturing Practice (GMP) guidelines per device master records.

Oversees the development of assays under design control (21 CFR part 820).

Oversees the development and performance of exploratory biomarker assays.

Organizes and analyzes data, draws conclusions, and assembles those conclusions in written format for sharing with stakeholders.

In conjunction with appropriate laboratory and QA staff, prepares and monitors procedures and schedules for quality control, equipment and instrument maintenance. Reviews and initials quality control and preventative maintenance records as defined by SOP. Ensures that testing frequency and results comply with all regulatory guidelines. Enforces compliance.

Assists the PharmaDx Directors in formulating and implementing strategic goals for the department in the technical area.

Provides budget information and needs to PharmaDx Directors.

Demonstrates advanced knowledge of applicable regulations and guidelines.

Contributes to planning, writing and conducting feasibility and verification studies for companion diagnostics and exploratory biomarkers.

Investigates and resolves technical problems, identifying root cause, and proposing process improvements through clear communication to PharmaDx Directors.

Maintains professional relationships with all relevant internal and external stakeholders.

Works independently and under the direction and general supervision of the PharmaDx Director.

Participates in PharmaDx Management Review meetings.

Other duties as assigned.

Physical and Other Requirements:

Stooping: Bending body downward and forward by bending spine at the waist.

Reaching: Extending hand(s) and arm(s) in any direction.

Mobility: The person in this position needs to occasionally move between work sites and inside the office to access file cabinets, office machinery, etc.

Communicate: Frequently and effectively communicate with others.

PPE: Biohazard laboratory environment that requires use of personal protective equipment in accordance with CDC and OSHA regulations and company policies.

ARUP Policies and Procedures: To conduct self in compliance with all ARUP Policies and Procedures.

Sedentary Work: Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body.

Fine Motor Control: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.

Vision: Having close, far, and peripheral visual acuity to perform a variety of tasks such as make general observations of depth

Qualifications

Education

Required

Bachelor's Degree or better in Biochemistry or related field.

Experience

Required

Six years of R&D experience Five years of experience in development, optimization, and/or validation of assays under design control and/or Good Manufacturing Practices Three years of demonstrated experience designing and interpreting spreadsheets and using word processing software in a research, IVD, pharmaceutical, and/or medical device manufacturing environment

Preferred

Advanced graduate degree in a relevant discipline Experience in pharmaceutical, IVD, or medical device industry working under design control Experience in companion diagnostics development and submission for FDA approval Experience in managing personnel Advanced experience with Microsoft Word, Excel and PowerPoint Excellent oral communication skills Excellent written communication skills

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 contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)