Senior Director, CMC Product Development Team Leader
Senior Director, CMC Product Development Team Leader
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1 Vacancy
Job Description
Overview
Iovance Biotherapeutics is seeking an Senior Director in the CMC organization
to support its Tumor Infiltrating Lymphocytes (TIL) products. This position is a critical leadership role within Iovances Commercial and Clinical programs focusing on coordinating and driving crossfunctional activities within the Chemistry Manufacturing and Controls (CMC) domain. As the CMC Lead this individual will need a blend of strategic leadership program management expertise and indepth knowledge of CMC processes in the pharmaceutical and biopharmaceutical industry.
The candidate should possess strong leadership skills be resourceful and be able to navigate complex crossfunctional environments effectively. They will need to balance highlevel strategic oversight with attention to operational details to ensure smooth execution of all CMCrelated activities.
Key responsibilities include:
Portfolio Management & Strategy: Overseeing and guiding the implementation of integrated CMC portfolio strategies for commercial and clinical products and associated goals budgets and timelines.
CrossFunctional Leadership:
Leading CMC teams and coordinating activities across multiple departments including Process and Analytical Development Manufacturing Sciences and Technology Analytical Sciences and Technology Manufacturing Quality Control Quality Assurance Regulatory CMC and Supply Chain.
Program Execution & Risk Management:
Managing the daytoday execution of the program strategy ensuring all CMC timelines and milestones are met. This will involve identifying risks and mitigating them in coordination with other departments.
Stakeholder Interaction:
Proactively managing the interactions between clinical commercial and CMC activities fostering strong relationships with key stakeholders.
Collaboration:
Working closely with the key stakeholders to determine project timelines manage resources and define the comprehensive portfolio strategy
Experience and ability to develop and deliver presentation to senior leadership
Strong understanding of project planning principles and ability to lead effectively
Must adhere to Iovance Biotherapeutics core values policies procedures and business ethics.
Perform miscellaneous duties as assigned.
Travel
- Travel < 1020% for meeting workshop presentations at Iovance facilities
Required Education Skills and Knowledge
- Bachelors degree in scientific discipline or related field required.
- 13 years of experience managing and leading multiple complex projects/programs within the biopharmaceutical industry.
- Demonstrated ability to manage multiple projects interfacing with multidisciplined teams.
- Basic understanding of scientific and quality principles as they apply to oncology drug products.
- Ability to apply scientific principles assess regulatory issues request and collect relevant information analyze data establish facts and draw valid conclusions.
- Excellent interpersonal verbal and written communication skills as well as the ability to effectively lead and influence others are essential in this collaborative work environment.
- Proven experience working and leading in a matrix environment.
- Comfortable in a fastpaced small company environment and able to adjust workload based upon changing priorities and ability to manage ambiguity.
- Able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic growing environment while providing clear direction to team members.
- Strong analytical problem solving and critical thinking skills.
- Demonstrate sense of urgency; ability to recognize time sensitivity
- Flexible and adaptable style with an eagerness to take on challenges
- Problem solver who not only identifies issues but leads efforts to resolve them
- Preferred Education Skills and Knowledge
- Familiarity/experience with endtoend CMC drug development and/or cell therapy.
- Previous experience supporting ramp up in a quality control environment.
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 remain in a stationary position standing or sitting for prolonged periods of time.
- Must be able to move about inside an office andexert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift carry push pull or otherwise move objects.
- Must have visual acuity to perform activities such as: preparing and analyzing data and figures viewing a computer screen and extensive reading.
- This position requires repetitive motion substantial movements (motions) of the wrist hands and/or fingers.
- Must be able to communicate with others to exchange information.
Mental: Clear and conceptual thinking ability; excellent judgment troubleshooting problemsolving analysis and discretion; ability to handle workrelated stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Work Environment
This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex bleach loud noise lab equipment hazards strong odors and chemical/biochemical is possible. Requires operating standard office equipment and keyboards.
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 to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equalopportunity employer our employees and applicants will be considered without regard to an individuals 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 contact .
By voluntarily providing information and clicking Submit Application you explicitly consent to the collection and use of your personal information for the purposes described above and in ourCandidate Privacy Notice.
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Required Experience:
Senior IC
Employment Type
Full-Time
