Senior Director, Quality Control, Microbiology

Job Description

Salary:

Overview

The Senior Director, Quality Control (QC) Microbiology, will lead the day-to-day operations of Iovance’s microbiology laboratory. The incumbent will direct microbial programs and staff for the company’s clinical and commercial programs at two manufacturing sites in Philadelphia. To be successful in this role, you will have strong leadership and substantial experience leading QC microbiology teams in a Pharmaceutical or Biotechnology environment. This position will be responsible for helping to ensure GMP compliance and the timely provision of test results.

Essential Functions and Responsibilities

Direct the day-to-day QC microbiology testing activities at the company’s two manufacturing facilities in Philadelphia.

Ensure all safety testing is performed according to company procedures and cGMP. Safety testing includes in-process and final products, aseptic process validation, operator qualification, stability, and environmental monitoring.

Support problem-solving during testing and for unexpected test results, working collaboratively with analysts and management as needed.

Ensure that QC staff are adequately trained and are performing tests per method procedures, and are consistent with implementing the required techniques.

Receive the technical transfer of revised or new methods, ensuring adequate documentation (i.e., written test method), controls, and training.

Initiate, revise, and approve site-related microbial Ensure all procedures reflect current operations. Serve as a document reviewer, owner, or approver as appropriate.

Participate in preparing CMC regulatory submissions and associated Health Authority interactions (e.g., IND, BLA submissions).

Support the QC function interface during facility tours and pre-approval inspections

Accurately interpret and discuss all laboratory-related data within cross functional teams and with health authorities

Required Education, Skills, and Knowledge

Bachelor’s degree in a relevant discipline (biological sciences or equivalent), advanced degree preferred

Minimum 12 years of experience in the pharmaceutical industry within a Quality Control microbiology role

Quality Control laboratory management experience, including management of direct reports

Broad knowledge of quality control for biologics with experience in a leadership role

Successfully interface with multi-disciplined teams

Extremely detail-oriented with strong analytical, written, and verbal communication skills

Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity

High level of ownership and accountability

Demonstrate a sense of urgency; ability to recognize time sensitivity

Flexible and adaptable style with an eagerness to take on challenges

Problem solver who identifies issues and leads efforts to resolve them

Preferred Education, Skills, and Knowledge

Advanced degree preferred

Experience with cell therapy products is a plus

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required:

Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE)

, i.e., scrubs, gowning coveralls, masks, gloves, etc.

Must meet requirements for and be able to wear a half-face respirator.

Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps

Must be able to use near vision to view samples at close range

Able to crouch, bend, twist, reach, and perform activities with repetitive motion

Must be able to lift and carry objects weighing 45 pounds

Mental:

Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to manage multiple priorities simultaneously; and ability to meet deadlines.

Work Environment:

This position will work in an office and a manufacturing lab setting

When in the lab, must be able to work in a Lab setting with various chemical/biochemical exposures, including latex and bleach.

Able to work in a cleanroom with biohazards, human blood components, and chemicials

Potential exposure to noise and equipment hazards and strong odors.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or change the position’s responsibilities at any time.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal- opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please get in touch with

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