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Associate Director, Autologous Cell Therapy Process Development - 2406176241W

Description

Johnson & Johnson is currently seeking an Associate Director, Autologous Cell Therapy Process Development to join our API Cell and Gene Therapy Organization located in Spring House, PA or Raritan, NJ.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

We are seeking an energetic and highly motivated candidate for the role of Associate Director, who possesses proven expertise in autologous cell therapy process development. The ideal candidate will be responsible for late-stage process development of autologous cell therapies, with a strong focus on process improvement, life-cycle management, and tech transfer. This role involves integrating new equipment/technologies, developing unit operations, and investigating root causes to facilitate transformative manufacturing processes for cGMP Manufacturing. The successful candidate will oversee the monitoring of Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs) using statistical analysis, ensuring the robustness and capability of manufacturing processes. They will also identify and implement process improvements to support the commercialization of cell therapy products. This position requires collaboration with a cross-functional team to support CMC development and commercial production.

Key Responsibilities

• Use own experience in cell therapy process development to guide autologous platform and process development efforts

• Collaborate with and participate in cross-functional teams to facilitate BLA enabling workstreams, BLA submission, commercial launching, and post-approval activities

• Identify, critically assess, and evaluate opportunities to improve manufacturing outcomes such as improving process robustness, manufacturing successful rate, product quality of final product, and reducing COGs

• Drive successful technology transfer activities, writing protocols, reports, and performing and coordinating activities to support successful manufacturing with internal and external partners

• Communicate program progress and issues to management, to regulatory agencies and at national conferences, if needed

• As a people leader manage and mentor to 3-4 scientists to support project activities

• Other duties, if needed

Qualifications

Education:

• PhD, MS, or BS in Immunology, Biological Sciences, or Biomedical Engineering are preferred, but equivalent experience in these fields, along with at least 5-8 years of relevant industry experience (academic experience post-graduate also considered), will also be considered.

Required:

• Knowledge of biology/immunology/biochemistry as applied in cell and gene therapy processes

• Previous experience in preparing CMC documents to support regulatory filings for post-approval changes to a commercial product

• Collaborate cross-functionally to develop cell therapies for future commercial production in support of BLA/NDA applications

• Maintain a high level of knowledge in cell therapy drug product manufacturing and characterization methodology through familiarity with scientific literature; share information with colleagues in CMC, R&D, QA and RA

• Problem-solving experience in cell therapy industry with an emphasis on pipeline projects

• Exposure to and knowledge of GMP manufacturing

• Demonstrated ability to work in a dynamic environment as a teammate with a strong work ethic

• Highly adaptable and responsive, and committed to completing tasks in a timely fashion

• Must be diligent, highly organized, and able to manage multiple tasks, handle tight timelines and deliver quality data

• Must have excellent communication, interpersonal and collaborative skills

Preferred:

• Extensive knowledge of process development strategies and effective approaches used in the biologics industry, from early development to late stage and commercialization.

Other:

• This role is based can be based in Spring House, PA or Raritan, NJ and may require up to 10% travel.

The anticipated base pay range for this position is $135,000 to $232,300.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k).

Employees are eligible for the following time off benefits:

• Vacation – up to 120 hours per calendar year.

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year.

• Holiday pay, including Floating Holidays – up to 13 days per calendar year.

• Work, Personal and Family Time - up to 40 hours per calendar year.

Additional information can be found through the link below.

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits .

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

Primary Location NA-US-Pennsylvania-Spring House

Other Locations NA-US-New Jersey-Raritan

Organization Janssen Research & Development, LLC (6084)

Relocation Eligible: Yes - Within Country

Travel Yes, 10 % of the Time

Job Function Biotherapeutics R&D

Req ID: 2406176241W